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Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure (GRAIL)

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ClinicalTrials.gov Identifier: NCT01335932
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : September 13, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Information provided by (Responsible Party):
Michael Boeckh, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Failure
Interventions Drug: IV Ganciclovir
Drug: Placebo
Enrollment 160

Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Period Title: Overall Study
Started 84 76
Completed 84 72
Not Completed 0 4
Arm/Group Title IV Ganciclovir Placebo Total
Hide Arm/Group Description

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Total of all reporting groups
Overall Number of Baseline Participants 84 76 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 76 participants 160 participants
55.2
(18 to 95)
58.2
(18 to 95)
56.6
(18 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 76 participants 160 participants
Female
35
  41.7%
36
  47.4%
71
  44.4%
Male
49
  58.3%
40
  52.6%
89
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 84 participants 76 participants 160 participants
84 76 160
1.Primary Outcome
Title Serum IL-6 Level
Hide Description Change between baseline and 14 days post-randomization between placebo & ganciclovir groups
Time Frame Baseline and Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.79  (0.65) -0.79  (0.69)
2.Secondary Outcome
Title Number of Participants With CMV Reactivation at 28 Days in Plasma
Hide Description Number of participants in baseline negatives with CMV reactivation at any level at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 77 67
Measure Type: Count of Participants
Unit of Measure: Participants
CMV viremia at any level
3
   3.9%
23
  34.3%
no CMV viremia at any level
74
  96.1%
44
  65.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title BAL Levels of IL-6
Hide Description Levels of IL-6 from BALs at 7 days post-randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
1.01  (0.78) 1.66  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Organ System Failure at 14 Days
Hide Description Number of participants experiencing organ system failure at 14 days
Time Frame at 14 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
with organ failure
0
   0.0%
2
   2.8%
without organ failure
84
 100.0%
70
  97.2%
5.Secondary Outcome
Title Number of Days Alive and Not in the ICU
Hide Description Number of ICU days alive and not in the ICU by day 28
Time Frame by 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: days
10.02  (6.84) 10.97  (8.23)
6.Secondary Outcome
Title CMV Disease
Hide Description Need to be biopsy-proven
Time Frame by 180 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
Biopsy proven CMV disease
0
   0.0%
0
   0.0%
No Biopsy proven CMV disease
84
 100.0%
72
 100.0%
7.Secondary Outcome
Title Grade 3 AEs or Higher
Hide Description Number of patients with greater than one AE of grade 3 or more
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
number with AE greater than grade 3
11
  13.1%
10
  13.9%
number without AE greater than grade 3
73
  86.9%
62
  86.1%
8.Secondary Outcome
Title SF-36 Health Survey
Hide Description Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time Frame at 1 day post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 53 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
36.37  (10.93) 35  (11.28)
9.Secondary Outcome
Title Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma
Hide Description Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 77 67
Measure Type: Count of Participants
Unit of Measure: Participants
CMV viremia >1,000 copies per mL
0
   0.0%
5
   7.5%
No CMV viremia >1,000 copies per mL
77
 100.0%
62
  92.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Incidence of CMV Reactivation at Any Level at 28 Days in Throat
Hide Description CMV reactivation in baseline negatives at any level at day 28 in throat
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 80 67
Measure Type: Count of Participants
Unit of Measure: Participants
CMV reactivation at any level at day 28 in throat
2
   2.5%
6
   9.0%
No CMV reactivation at any level at day 28in throa
78
  97.5%
61
  91.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat
Hide Description Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 80 67
Measure Type: Count of Participants
Unit of Measure: Participants
CMV reactivation >1,000 in IU per mL
0
   0.0%
1
   1.5%
No CMV reactivation >1,000 IU per mL in throat
80
 100.0%
66
  98.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title CMV AUC in Blood
Hide Description CMV AUC in blood from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
0.11  (0.39) 0.39  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title CMV AUC in Throat
Hide Description CMV AUC in Throat from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
0.03  (0.14) 0.17  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title CMV Peak Viral Load in Blood
Hide Description CMV Peak Viremia in blood at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 IU/mL
0.24  (0.67) 0.89  (1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title BAL Levels of IL-8
Hide Description Levels of IL-8 in BALs at day 7
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
2.21  (0.66) 2.61  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title BAL Levels of TNFa
Hide Description Levels of TNFa in BALs at day 7
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
0.18  (0) 0.46  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Plasma Levels of IL-6
Hide Description Plasma levels of IL-6.
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
0.87  (0.84) 0.92  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Plasma Levels of IL-8
Hide Description Levels of IL-8 in plasma at day 7
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
1.38  (0.6) 1.38  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Plasma Levels of TNF a
Hide Description Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
-0.07  (0.36) -0.1  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Plasma Levels of TNF a
Hide Description Plasma levels of TNF a from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cytokines are summarized on a log 10 scale. When the logged value is negative, the raw value would be less than 1.
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
-0.06  (0.37) -0.11  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Plasma Levels of IL-6
Hide Description Plasma levels of IL-6 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
0.35  (0.51) 0.59  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Plasma Levels of IL-8
Hide Description Plasma levels of IL-8 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
1.09  (0.46) 1.27  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Plasma Levels of Soluble ICAM-1
Hide Description Plasma levels of soluble ICAM-1 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
5.34  (0.19) 5.48  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
24.Secondary Outcome
Title Plasma Levels of Soluble ICAM-1
Hide Description Plasma levels of soluble ICAM-1 at day 7
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
5.43  (0.21) 5.45  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Peak Plasma Levels of Soluble ICAM-1
Hide Description Peak Plasma levels of soluble ICAM-1 from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
5.52  (0.2) 5.57  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
26.Secondary Outcome
Title Peak Plasma Levels of TNF-a
Hide Description Peak Plasma levels of TNF-a at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
0.16  (0.3) 0.17  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title Peak Plasma Levels of IL-10
Hide Description Peak Plasma levels of IL-10 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
0.88  (0.52) 0.82  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title Peak Plasma Levels of IL-8
Hide Description Peak Plasma levels of IL-8 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
1.67  (0.65) 1.66  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
29.Secondary Outcome
Title Peak Plasma Levels of IL-6
Hide Description Peak Plasma levels of IL-6 at day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: log 10 pg/mL
1.57  (0.78) 1.56  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
30.Secondary Outcome
Title AUC Plasma Levels of IL-6
Hide Description AUC Plasma levels of IL-6 from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
0.68  (0.49) 0.75  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
31.Secondary Outcome
Title AUC Plasma Levels of IL-8
Hide Description AUC Plasma levels of IL-8 from day 0 to day 28
Time Frame Day 0 to 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
1.15  (0.45) 1.13  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
32.Secondary Outcome
Title AUC Plasma Levels of IL-10
Hide Description AUC Plasma levels of IL-10 from day 0 to day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
0.36  (0.36) 0.35  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
33.Secondary Outcome
Title AUC Plasma Levels of TNF-a
Hide Description AUC Plasma levels of TNF-a from day 0 to day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
-0.14  (0.28) -0.14  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
34.Secondary Outcome
Title AUC Plasma Levels of Soluble ICAM-1
Hide Description AUC Plasma levels of soluble ICAM-1 from day 0 to day 28
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: IU*day/mL
4.78  (0.98) 4.65  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Ganciclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
35.Secondary Outcome
Title Length of Stay
Hide Description Hospital days alive and not hospitalized by day 180
Time Frame by 180 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 55 47
Mean (Standard Deviation)
Unit of Measure: days
145.13  (47.63) 145.94  (47.88)
36.Secondary Outcome
Title Length of Stay
Hide Description Hospital days alive and not hospitalized by day 28
Time Frame by 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 78 69
Mean (Standard Deviation)
Unit of Measure: days
9.96  (8.52) 8.72  (8.24)
37.Secondary Outcome
Title Organ System Failure at 28 Days
Hide Description Number of participants with organ system failure at 28 days
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
with organ failure
0
   0.0%
2
   2.8%
without organ failure
84
 100.0%
70
  97.2%
38.Secondary Outcome
Title Duration of Mechanical Ventilation as Assessed by Ventilator Free Days
Hide Description Number of days of mechanical ventilation duration as assessed by ventilator free days
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: days
18.71  (9.08) 15.97  (9.72)
39.Secondary Outcome
Title Duration of Mechanical Ventilation as Assessed by Ventilator Days
Hide Description Number of days of mechanical ventilation duration as assessed by ventilator days
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: days
6.95  (6.16) 8.5  (7.17)
40.Secondary Outcome
Title Bacteremia and/or Fungemia
Hide Description Number of participants with bacteremia and/or fungemia
Time Frame at 28 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
with bacteremia and /or fungemia
15
  17.9%
11
  15.3%
without bacteremia and /or fungemia
69
  82.1%
61
  84.7%
41.Secondary Outcome
Title Mortality
Hide Description Mortality at 60 days post randomization
Time Frame at 60 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
dead
13
  15.5%
12
  16.7%
alive
71
  84.5%
60
  83.3%
42.Secondary Outcome
Title Mortality at 180 Days
Hide Description Mortality at 180 days post-randomization
Time Frame at 180 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
dead
18
  21.4%
19
  26.4%
alive
66
  78.6%
53
  73.6%
43.Secondary Outcome
Title SF-36 Functional Assessment Physical Component
Hide Description Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame at 180 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 40 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
35.51  (11.38) 38.17  (10.96)
44.Secondary Outcome
Title SF-36 Functional Assessment Mental Component
Hide Description Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame at 180 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 40 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
45.55  (11.52) 44.08  (12.25)
45.Secondary Outcome
Title SF-36 Functional Assessment Mental Component on Day 1
Hide Description SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame at 1 day post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 53 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
43.83  (12) 42.73  (13.78)
46.Secondary Outcome
Title Patients With Serious Adverse Events
Hide Description Number of patients with Serious Adverse Events by day 35
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with a Serious adverse event
0
   0.0%
0
   0.0%
Number of patients without a Serious adverse event
84
 100.0%
72
 100.0%
47.Secondary Outcome
Title Time to Neutropenia
Hide Description Time to neutropenia by 35 days post-randomization
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Number
Unit of Measure: days
0 0
48.Secondary Outcome
Title Use of Granulocyte-colony Stimulating Factor
Hide Description Number of participants requiring Granulocyte-colony stimulating factor
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients that required GCSF
0
   0.0%
0
   0.0%
Number of patients that did not require GCSF
84
 100.0%
72
 100.0%
49.Secondary Outcome
Title Renal Insufficiency
Hide Description Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
Glomerular filtration rate less than 60 mL/min
36
  42.9%
41
  56.9%
Glomerular filtration rate greater than 60 mL/min
48
  57.1%
31
  43.1%
50.Secondary Outcome
Title Red Blood Cell Transfusions Required Per Patients
Hide Description Red blood cell transfusions required per patients by day 35
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Median (Inter-Quartile Range)
Unit of Measure: transfusions
2
(1 to 2)
1
(1 to 4)
51.Secondary Outcome
Title Platelet Transfusions
Hide Description Platelet transfusions per patient
Time Frame by 35 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 721
Median (Inter-Quartile Range)
Unit of Measure: transfusions
1
(1 to 1)
1
(1 to 2)
52.Secondary Outcome
Title Clinical Outcomes
Hide Description Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine.
Time Frame at 14 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 84 72
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with composite endpoint
42
  50.0%
49
  68.1%
Number of patients without composite endpoint
42
  50.0%
23
  31.9%
53.Secondary Outcome
Title Bacteremia and Fungemia Outcomes
Hide Description Bacteremia and fungemia outcomes among subjects who survive at least 7 days
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Measure Type: Number
Unit of Measure: events
number of events 15 9
number of no events 67 55
54.Secondary Outcome
Title Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets
Hide Description Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame at 7 through 14 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Measure Type: Number
Unit of Measure: events
number of events 6 9
number of no events 24 24
55.Secondary Outcome
Title Overall Mortality
Hide Description Overall mortality amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Measure Type: Number
Unit of Measure: events
number of deaths 16 11
number of alive 66 53
56.Secondary Outcome
Title Number of Mechanical Ventilated Days
Hide Description Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Mean (Standard Deviation)
Unit of Measure: days
7.05  (6.19) 9.05  (7.4)
57.Secondary Outcome
Title Number of Ventilator-free Days
Hide Description Number of ventilator-free days amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Mean (Standard Deviation)
Unit of Measure: days
19.17  (8.7) 17.97  (8.37)
58.Secondary Outcome
Title Number of Days in the ICU
Hide Description Number of days in the ICU amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Mean (Standard Deviation)
Unit of Measure: days
10.20  (6.82) 11.83  (8.32)
59.Secondary Outcome
Title Number of ICU-free Days
Hide Description Number of ICU-free days amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 82 64
Mean (Standard Deviation)
Unit of Measure: days
15.38  (27) 13.89  (25)
60.Secondary Outcome
Title Number of Days in the Hospital
Hide Description Number of days in the hospital amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 67 57
Mean (Standard Deviation)
Unit of Measure: days
6.21  (4.85) 5.53  (4.9)
61.Secondary Outcome
Title Number of Hospital-free Days
Hide Description Number of hospital-free days amongst subjects who survive at least 7 days after randomization
Time Frame at 7 days post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 76 61
Mean (Standard Deviation)
Unit of Measure: days
10.22  (8.47) 9.87  (8.09)
62.Secondary Outcome
Title Mortality Among Subjects Mechanically Ventilated From Day 7 to 14
Hide Description Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Measure Type: Number
Unit of Measure: events
number of events 9 6
number of no events 21 27
63.Secondary Outcome
Title Number of Mechanically Ventilated Days Among Subjects by Day 28
Hide Description Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Mean (Standard Deviation)
Unit of Measure: days
13.4  (6.12) 14.42  (6.64)
64.Secondary Outcome
Title Number of Ventilator-free Days Among Subjects by Day 28
Hide Description Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Mean (Standard Deviation)
Unit of Measure: days
11.4  (8.29) 12.45  (7.26)
65.Secondary Outcome
Title Number of Days in ICU Amongst Subjects by Day 28
Hide Description Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Mean (Standard Deviation)
Unit of Measure: days
16.73  (5.75) 17.79  (7.41)
66.Secondary Outcome
Title Number of ICU-free Days Amongst Subjects by Day 28
Hide Description Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 30 33
Mean (Standard Deviation)
Unit of Measure: days
7.73  (18) 8.15  (18)
67.Secondary Outcome
Title Number of Hospital-free Days Among Subjects by Day 28
Hide Description Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description:

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Overall Number of Participants Analyzed 28 32
Mean (Standard Deviation)
Unit of Measure: days
3.54  (5.15) 4.59  (5.55)
Time Frame Clinical adverse events were collected from day 1(start of study drug) through day 35 (7 days after the stop of study drug).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Ganciclovir Placebo
Hide Arm/Group Description

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

All-Cause Mortality
IV Ganciclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/84 (11.90%)   11/72 (15.28%) 
Show Serious Adverse Events Hide Serious Adverse Events
IV Ganciclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/72 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Ganciclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/72 (0.00%) 
Inclusion of too few trauma patients to assess treatment effects, a long enrollment window length, discontinuation of BAL sampling due to feasibility and changes in oral drug availability (later part of the study)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr.Michael Boeckh
Organization: FHCRC
Phone: 206 667-6706
Responsible Party: Michael Boeckh, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01335932     History of Changes
Other Study ID Numbers: 7217
U01HL102547 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2011
First Posted: April 15, 2011
Results First Submitted: June 21, 2017
Results First Posted: September 13, 2017
Last Update Posted: August 21, 2018