Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376321
Recruitment Status : Terminated (Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.)
First Posted : December 18, 2017
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Influenza A
Interventions Drug: Pimodivir 600 mg
Drug: Placebo
Other: SOC Treatment
Enrollment 334
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid. Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Period Title: Overall Study
Started 168 166
Treated 163 163
Completed 145 141
Not Completed 23 25
Reason Not Completed
Other             5             1
Withdrawal by Subject             8             14
Lost to Follow-up             1             7
Death             4             0
Randomized, not treated             5             3
Arm/Group Title Pimodivir + SOC Placebo + SOC Total
Hide Arm/Group Description Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid. Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid. Total of all reporting groups
Overall Number of Baseline Participants 163 163 326
Hide Baseline Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 163 participants 326 participants
59.7  (15.46) 57.7  (16.88) 58.7  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 163 participants 326 participants
Female
92
  56.4%
75
  46.0%
167
  51.2%
Male
71
  43.6%
88
  54.0%
159
  48.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 163 participants 326 participants
Hispanic or Latino
27
  16.6%
22
  13.5%
49
  15.0%
Not Hispanic or Latino
132
  81.0%
132
  81.0%
264
  81.0%
Unknown or Not Reported
4
   2.5%
9
   5.5%
13
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 163 participants 326 participants
American Indian or Alaska Native
4
   2.5%
2
   1.2%
6
   1.8%
Asian
34
  20.9%
30
  18.4%
64
  19.6%
Native Hawaiian or Other Pacific Islander
1
   0.6%
1
   0.6%
2
   0.6%
Black or African American
5
   3.1%
11
   6.7%
16
   4.9%
White
113
  69.3%
114
  69.9%
227
  69.6%
More than one race
3
   1.8%
0
   0.0%
3
   0.9%
Unknown or Not Reported
3
   1.8%
5
   3.1%
8
   2.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 163 participants 326 participants
ARGENTINA
4
   2.5%
5
   3.1%
9
   2.8%
AUSTRALIA
1
   0.6%
1
   0.6%
2
   0.6%
AUSTRIA
8
   4.9%
10
   6.1%
18
   5.5%
BELGIUM
0
   0.0%
2
   1.2%
2
   0.6%
BRAZIL
3
   1.8%
0
   0.0%
3
   0.9%
BULGARIA
5
   3.1%
5
   3.1%
10
   3.1%
CANADA
1
   0.6%
0
   0.0%
1
   0.3%
CHILE
0
   0.0%
1
   0.6%
1
   0.3%
FRANCE
2
   1.2%
7
   4.3%
9
   2.8%
GERMANY
0
   0.0%
1
   0.6%
1
   0.3%
INDIA
8
   4.9%
10
   6.1%
18
   5.5%
ISRAEL
20
  12.3%
16
   9.8%
36
  11.0%
ITALY
4
   2.5%
0
   0.0%
4
   1.2%
LATVIA
2
   1.2%
1
   0.6%
3
   0.9%
LITHUANIA
1
   0.6%
3
   1.8%
4
   1.2%
MALAYSIA
12
   7.4%
9
   5.5%
21
   6.4%
MEXICO
7
   4.3%
5
   3.1%
12
   3.7%
NETHERLANDS
1
   0.6%
2
   1.2%
3
   0.9%
NEW ZEALAND
0
   0.0%
1
   0.6%
1
   0.3%
POLAND
12
   7.4%
12
   7.4%
24
   7.4%
RUSSIAN FEDERATION
1
   0.6%
0
   0.0%
1
   0.3%
SINGAPORE
0
   0.0%
2
   1.2%
2
   0.6%
SLOVAKIA
0
   0.0%
1
   0.6%
1
   0.3%
SOUTH AFRICA
9
   5.5%
8
   4.9%
17
   5.2%
SPAIN
13
   8.0%
11
   6.7%
24
   7.4%
SWEDEN
8
   4.9%
8
   4.9%
16
   4.9%
TAIWAN
1
   0.6%
0
   0.0%
1
   0.3%
THAILAND
12
   7.4%
10
   6.1%
22
   6.7%
TURKEY
3
   1.8%
5
   3.1%
8
   2.5%
UKRAINE
6
   3.7%
8
   4.9%
14
   4.3%
UNITED KINGDOM
1
   0.6%
0
   0.0%
1
   0.3%
UNITED STATES
17
  10.4%
19
  11.7%
36
  11.0%
VIETNAM
1
   0.6%
0
   0.0%
1
   0.3%
1.Primary Outcome
Title Number of Participants With Hospital Recovery Scale on Day 6
Hide Description The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 152 145
Measure Type: Count of Participants
Unit of Measure: Participants
Any time since onset influenza: Not hospitalized Number Analyzed 152 participants 145 participants
73
  48.0%
69
  47.6%
Any time since onset influenza: Non-ICU hospitalization, not requiring supplemental oxygen Number Analyzed 152 participants 145 participants
50
  32.9%
42
  29.0%
Any time since onset influenza: Non-ICU hospitalization, requiring supplemental oxygen Number Analyzed 152 participants 145 participants
18
  11.8%
25
  17.2%
Any time since onset influenza: Admitted to the ICU, not requiring invasive mechanical ventilation Number Analyzed 152 participants 145 participants
6
   3.9%
6
   4.1%
Any time since onset influenza: Requiring invasive mechanical ventilation Number Analyzed 152 participants 145 participants
2
   1.3%
3
   2.1%
Any time since onset influenza: Death Number Analyzed 152 participants 145 participants
3
   2.0%
0
   0.0%
Time since onset influenza less than or equal to (<=)72 hour (h): Not hospitalized Number Analyzed 122 participants 114 participants
61
  50.0%
56
  49.1%
Time since onset influenza <=72h: Non-ICU hospitalization, not requiring supplemental oxygen Number Analyzed 122 participants 114 participants
38
  31.1%
32
  28.1%
Time since onset influenza <=72h: Non-ICU hospitalization, requiring supplemental oxygen Number Analyzed 122 participants 114 participants
15
  12.3%
19
  16.7%
Time since onset influenza <=72h: Admitted to the ICU, not requiring invasive mechanical ventilation Number Analyzed 122 participants 114 participants
4
   3.3%
5
   4.4%
Time since onset influenza <=72h: Requiring invasive mechanical ventilation Number Analyzed 122 participants 114 participants
2
   1.6%
2
   1.8%
Time since onset influenza <=72h: Death Number Analyzed 122 participants 114 participants
2
   1.6%
0
   0.0%
Time since onset influenza greater than (>) 72h: Not hospitalized Number Analyzed 30 participants 31 participants
12
  40.0%
13
  41.9%
Time since onset influenza >72h: Non-ICU hospitalization, not requiring supplemental oxygen Number Analyzed 30 participants 31 participants
12
  40.0%
10
  32.3%
Time since onset influenza >72h: Non-ICU hospitalization, requiring supplemental oxygen Number Analyzed 30 participants 31 participants
3
  10.0%
6
  19.4%
Time since onset influenza >72h: Admitted to the ICU, not requiring invasive mechanical ventilation Number Analyzed 30 participants 31 participants
2
   6.7%
1
   3.2%
Time since onset influenza >72h: Requiring invasive mechanical ventilation Number Analyzed 30 participants 31 participants
0
   0.0%
1
   3.2%
Time since onset influenza >72h: Death Number Analyzed 30 participants 31 participants
1
   3.3%
0
   0.0%
2.Secondary Outcome
Title Time to Hospital Discharge
Hide Description The time to hospital discharge was defined as the time from start of study drug to hospital discharge.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND (randomized participants with a randomization date time at or before the date time of first intake of study drug, or with a randomization date time and no study drug intake) analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 159 159
Median (95% Confidence Interval)
Unit of Measure: hours
113
(94.20 to 118.50)
108
(92.70 to 116.30)
3.Secondary Outcome
Title Number of Participants With Adjudicated Influenza Complications
Hide Description Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 159 159
Measure Type: Count of Participants
Unit of Measure: Participants
Any time since onset influenza Number Analyzed 159 participants 159 participants
28
  17.6%
29
  18.2%
Time since onset influenza <=72h Number Analyzed 128 participants 126 participants
24
  18.8%
24
  19.0%
Time since onset influenza >72h Number Analyzed 31 participants 33 participants
4
  12.9%
5
  15.2%
4.Secondary Outcome
Title Viral Load Over Time
Hide Description Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Time Frame Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 153 151
Mean (Standard Deviation)
Unit of Measure: Log 10 viral particles per milliliter
Baseline Number Analyzed 153 participants 151 participants
5.657  (1.4693) 5.655  (1.4117)
Day 1 Number Analyzed 3 participants 4 participants
5.433  (1.3102) 6.410  (0.7826)
Day 2 Number Analyzed 151 participants 147 participants
4.561  (1.5133) 4.794  (1.4154)
Day 3 Number Analyzed 132 participants 125 participants
3.913  (1.4202) 4.057  (1.3425)
Day 4 Number Analyzed 109 participants 104 participants
3.460  (1.4952) 3.634  (1.2207)
Day 5 Number Analyzed 92 participants 85 participants
3.133  (1.3500) 3.157  (1.1112)
Day 6 Number Analyzed 74 participants 68 participants
2.552  (0.7100) 2.876  (0.9750)
Day 7 Number Analyzed 4 participants 7 participants
2.103  (0.0350) 2.269  (0.3829)
Day 8 Number Analyzed 24 participants 27 participants
2.386  (0.7052) 2.463  (0.7051)
Day 9 Number Analyzed 2 participants 7 participants
2.050  (0.0000) 2.611  (0.8281)
Day 10 Number Analyzed 138 participants 121 participants
2.287  (0.6518) 2.346  (0.6357)
Day 11 Number Analyzed 1 participants 0 participants
2.050
Day 14 Number Analyzed 135 participants 126 participants
2.137  (0.4163) 2.116  (0.2109)
Day 19 Number Analyzed 4 participants 3 participants
2.050  (0.0000) 2.050  (0.0000)
5.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
85
  52.1%
84
  51.5%
6.Secondary Outcome
Title Number of Participants With Emergence of Viral Resistance to Pimodivir
Hide Description Emergence of viral resistance to Pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 159 159
Measure Type: Count of Participants
Unit of Measure: Participants
Neuraminidase (NA) region: With emerging mutations of interest
0
   0.0%
3
   1.9%
Polymerase basic protein (PB) 2 region: With emerging mutations of interest
2
   1.3%
0
   0.0%
7.Secondary Outcome
Title Plasma Concentration of Pimodivir
Hide Description Plasma concentration of Pimodivir was reported.
Time Frame Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category.
Arm/Group Title Pimodivir + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
Day 1: 1 hour30minutes to 6 hours postdose Number Analyzed 141 participants
1696.3  (2298.4)
Day 3: Pre-Dose Number Analyzed 127 participants
854.3  (898.3)
Day 5: Pre-Dose Number Analyzed 82 participants
940.3  (1081.1)
Day 5: 1 hour30minutes to 6 hours postdose Number Analyzed 79 participants
3046.7  (3860.5)
Day 6: 12hours post dose Number Analyzed 55 participants
938.2  (1374.7)
8.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Laboratory Tests
Hide Description Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis were collected at predefined time points for clinical laboratory testing.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Hide Description Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs
Hide Description Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) was reported.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description:
Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Up to Day 33
Adverse Event Reporting Description The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
 
Arm/Group Title Pimodivir + SOC Placebo + SOC
Hide Arm/Group Description Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
All-Cause Mortality
Pimodivir + SOC Placebo + SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   4/163 (2.45%)   0/163 (0.00%) 
Hide Serious Adverse Events
Pimodivir + SOC Placebo + SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   13/163 (7.98%)   15/163 (9.20%) 
Cardiac disorders     
Acute Left Ventricular Failure * 1  0/163 (0.00%)  1/163 (0.61%) 
Cardiac Arrest * 1  2/163 (1.23%)  0/163 (0.00%) 
Cardiac Failure * 1  0/163 (0.00%)  1/163 (0.61%) 
Cardiac Failure Congestive * 1  1/163 (0.61%)  0/163 (0.00%) 
Left Ventricular Failure * 1  1/163 (0.61%)  0/163 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/163 (0.61%)  0/163 (0.00%) 
Immune system disorders     
Drug Hypersensitivity * 1  0/163 (0.00%)  1/163 (0.61%) 
Infections and infestations     
Abscess Limb * 1  0/163 (0.00%)  1/163 (0.61%) 
Parotitis * 1  0/163 (0.00%)  1/163 (0.61%) 
Pneumonia * 1  1/163 (0.61%)  1/163 (0.61%) 
Pneumonia Bacterial * 1  0/163 (0.00%)  1/163 (0.61%) 
Pneumonia Escherichia * 1  1/163 (0.61%)  0/163 (0.00%) 
Pneumonia Klebsiella * 1  0/163 (0.00%)  1/163 (0.61%) 
Pneumonia Pneumococcal * 1  0/163 (0.00%)  1/163 (0.61%) 
Postoperative Wound Infection * 1  1/163 (0.61%)  0/163 (0.00%) 
Respiratory Tract Infection * 1  1/163 (0.61%)  0/163 (0.00%) 
Septic Shock * 1  1/163 (0.61%)  0/163 (0.00%) 
Nervous system disorders     
Transient Ischaemic Attack * 1  0/163 (0.00%)  1/163 (0.61%) 
Renal and urinary disorders     
Urinary Retention * 1  0/163 (0.00%)  1/163 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  0/163 (0.00%)  1/163 (0.61%) 
Acute Respiratory Failure * 1  1/163 (0.61%)  0/163 (0.00%) 
Aspiration * 1  1/163 (0.61%)  0/163 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  1/163 (0.61%)  0/163 (0.00%) 
Dyspnoea * 1  1/163 (0.61%)  0/163 (0.00%) 
Hydrothorax * 1  0/163 (0.00%)  1/163 (0.61%) 
Pulmonary Congestion * 1  0/163 (0.00%)  1/163 (0.61%) 
Respiratory Distress * 1  0/163 (0.00%)  1/163 (0.61%) 
Respiratory Failure * 1  1/163 (0.61%)  1/163 (0.61%) 
Wheezing * 1  1/163 (0.61%)  0/163 (0.00%) 
Vascular disorders     
Venous Thrombosis Limb * 1  1/163 (0.61%)  0/163 (0.00%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pimodivir + SOC Placebo + SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   81/163 (49.69%)   82/163 (50.31%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/163 (1.23%)  0/163 (0.00%) 
Anaemia of Chronic Disease * 1  0/163 (0.00%)  1/163 (0.61%) 
Hypereosinophilic Syndrome * 1  1/163 (0.61%)  0/163 (0.00%) 
Leukopenia * 1  0/163 (0.00%)  1/163 (0.61%) 
Macrocytosis * 1  1/163 (0.61%)  0/163 (0.00%) 
Neutropenia * 1  1/163 (0.61%)  1/163 (0.61%) 
Thrombocytopenia * 1  0/163 (0.00%)  1/163 (0.61%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/163 (0.61%)  0/163 (0.00%) 
Bradycardia * 1  0/163 (0.00%)  2/163 (1.23%) 
Cardiac Failure Acute * 1  1/163 (0.61%)  0/163 (0.00%) 
Cardiomegaly * 1  0/163 (0.00%)  1/163 (0.61%) 
Myocardial Ischaemia * 1  0/163 (0.00%)  1/163 (0.61%) 
Palpitations * 1  1/163 (0.61%)  1/163 (0.61%) 
Supraventricular Tachycardia * 1  0/163 (0.00%)  1/163 (0.61%) 
Congenital, familial and genetic disorders     
Dermoid Cyst * 1  1/163 (0.61%)  0/163 (0.00%) 
Ear and labyrinth disorders     
Ear Pain * 1  0/163 (0.00%)  1/163 (0.61%) 
Vertigo * 1  1/163 (0.61%)  2/163 (1.23%) 
Eye disorders     
Cataract * 1  1/163 (0.61%)  0/163 (0.00%) 
Chalazion * 1  1/163 (0.61%)  0/163 (0.00%) 
Conjunctivitis Allergic * 1  0/163 (0.00%)  1/163 (0.61%) 
Dry Eye * 1  1/163 (0.61%)  0/163 (0.00%) 
Photophobia * 1  1/163 (0.61%)  0/163 (0.00%) 
Vision Blurred * 1  1/163 (0.61%)  0/163 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  0/163 (0.00%)  1/163 (0.61%) 
Abdominal Pain Upper * 1  2/163 (1.23%)  1/163 (0.61%) 
Constipation * 1  1/163 (0.61%)  3/163 (1.84%) 
Diarrhoea * 1  15/163 (9.20%)  15/163 (9.20%) 
Diarrhoea Haemorrhagic * 1  1/163 (0.61%)  0/163 (0.00%) 
Dyspepsia * 1  3/163 (1.84%)  5/163 (3.07%) 
Dysphagia * 1  1/163 (0.61%)  0/163 (0.00%) 
Gastritis * 1  0/163 (0.00%)  1/163 (0.61%) 
Gastrooesophageal Reflux Disease * 1  1/163 (0.61%)  0/163 (0.00%) 
Ileus * 1  1/163 (0.61%)  0/163 (0.00%) 
Nausea * 1  3/163 (1.84%)  7/163 (4.29%) 
Oral Pruritus * 1  0/163 (0.00%)  1/163 (0.61%) 
Proctalgia * 1  1/163 (0.61%)  0/163 (0.00%) 
Vomiting * 1  1/163 (0.61%)  2/163 (1.23%) 
General disorders     
Asthenia * 1  2/163 (1.23%)  1/163 (0.61%) 
Chills * 1  0/163 (0.00%)  1/163 (0.61%) 
Fatigue * 1  2/163 (1.23%)  1/163 (0.61%) 
Malaise * 1  0/163 (0.00%)  1/163 (0.61%) 
Multiple Organ Dysfunction Syndrome * 1  1/163 (0.61%)  0/163 (0.00%) 
Nodule * 1  0/163 (0.00%)  1/163 (0.61%) 
Non-Cardiac Chest Pain * 1  0/163 (0.00%)  2/163 (1.23%) 
Oedema Peripheral * 1  2/163 (1.23%)  3/163 (1.84%) 
Peripheral Swelling * 1  1/163 (0.61%)  0/163 (0.00%) 
Pyrexia * 1  1/163 (0.61%)  2/163 (1.23%) 
Vessel Puncture Site Bruise * 1  1/163 (0.61%)  0/163 (0.00%) 
Hepatobiliary disorders     
Hepatic Function Abnormal * 1  1/163 (0.61%)  0/163 (0.00%) 
Hepatitis * 1  2/163 (1.23%)  0/163 (0.00%) 
Hepatitis Toxic * 1  0/163 (0.00%)  1/163 (0.61%) 
Infections and infestations     
Abscess Limb * 1  0/163 (0.00%)  1/163 (0.61%) 
Bronchitis * 1  1/163 (0.61%)  2/163 (1.23%) 
Bronchitis Bacterial * 1  1/163 (0.61%)  0/163 (0.00%) 
Candida Infection * 1  0/163 (0.00%)  1/163 (0.61%) 
Cellulitis * 1  0/163 (0.00%)  1/163 (0.61%) 
Clostridium Difficile Colitis * 1  1/163 (0.61%)  0/163 (0.00%) 
Conjunctivitis * 1  0/163 (0.00%)  1/163 (0.61%) 
Fungal Infection * 1  1/163 (0.61%)  0/163 (0.00%) 
Fungal Skin Infection * 1  0/163 (0.00%)  1/163 (0.61%) 
Gastroenteritis * 1  1/163 (0.61%)  0/163 (0.00%) 
Genital Herpes * 1  1/163 (0.61%)  0/163 (0.00%) 
Herpes Simplex * 1  0/163 (0.00%)  1/163 (0.61%) 
Herpes Zoster * 1  1/163 (0.61%)  0/163 (0.00%) 
Impetigo * 1  0/163 (0.00%)  1/163 (0.61%) 
Nasopharyngitis * 1  2/163 (1.23%)  0/163 (0.00%) 
Oral Candidiasis * 1  2/163 (1.23%)  2/163 (1.23%) 
Oral Fungal Infection * 1  1/163 (0.61%)  0/163 (0.00%) 
Oral Herpes * 1  2/163 (1.23%)  2/163 (1.23%) 
Pharyngitis * 1  2/163 (1.23%)  0/163 (0.00%) 
Pneumonia * 1  2/163 (1.23%)  2/163 (1.23%) 
Pneumonia Bacterial * 1  0/163 (0.00%)  1/163 (0.61%) 
Pneumonia Haemophilus * 1  0/163 (0.00%)  2/163 (1.23%) 
Pneumonia Staphylococcal * 1  0/163 (0.00%)  1/163 (0.61%) 
Respiratory Tract Infection * 1  1/163 (0.61%)  1/163 (0.61%) 
Septic Shock * 1  1/163 (0.61%)  0/163 (0.00%) 
Staphylococcal Bacteraemia * 1  0/163 (0.00%)  1/163 (0.61%) 
Superinfection Bacterial * 1  0/163 (0.00%)  1/163 (0.61%) 
Upper Respiratory Tract Infection * 1  1/163 (0.61%)  0/163 (0.00%) 
Urinary Tract Infection * 1  2/163 (1.23%)  1/163 (0.61%) 
Urinary Tract Infection Staphylococcal * 1  0/163 (0.00%)  1/163 (0.61%) 
Vulvovaginal Candidiasis * 1  1/163 (0.61%)  0/163 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/163 (0.61%)  0/163 (0.00%) 
Haematuria Traumatic * 1  1/163 (0.61%)  0/163 (0.00%) 
Traumatic Haemorrhage * 1  0/163 (0.00%)  1/163 (0.61%) 
Investigations     
Alanine Aminotransferase Abnormal * 1  1/163 (0.61%)  0/163 (0.00%) 
Alanine Aminotransferase Increased * 1  1/163 (0.61%)  2/163 (1.23%) 
Amylase Increased * 1  1/163 (0.61%)  1/163 (0.61%) 
Aspartate Aminotransferase Increased * 1  1/163 (0.61%)  1/163 (0.61%) 
Blood Creatine Phosphokinase Increased * 1  1/163 (0.61%)  1/163 (0.61%) 
Blood Creatinine Increased * 1  1/163 (0.61%)  0/163 (0.00%) 
Blood Uric Acid Increased * 1  1/163 (0.61%)  0/163 (0.00%) 
Electrocardiogram Abnormal * 1  1/163 (0.61%)  0/163 (0.00%) 
Gamma-Glutamyltransferase Increased * 1  1/163 (0.61%)  2/163 (1.23%) 
Hepatic Enzyme Increased * 1  2/163 (1.23%)  0/163 (0.00%) 
Lipase Increased * 1  1/163 (0.61%)  0/163 (0.00%) 
Neutrophil Count Decreased * 1  1/163 (0.61%)  0/163 (0.00%) 
Pancreatic Enzymes Increased * 1  1/163 (0.61%)  0/163 (0.00%) 
Platelet Count Decreased * 1  0/163 (0.00%)  1/163 (0.61%) 
Transaminases Increased * 1  0/163 (0.00%)  1/163 (0.61%) 
Metabolism and nutrition disorders     
Diabetes Mellitus * 1  1/163 (0.61%)  0/163 (0.00%) 
Diabetic Metabolic Decompensation * 1  1/163 (0.61%)  0/163 (0.00%) 
Fluid Overload * 1  1/163 (0.61%)  0/163 (0.00%) 
Fluid Retention * 1  1/163 (0.61%)  0/163 (0.00%) 
Gout * 1  0/163 (0.00%)  1/163 (0.61%) 
Hyperglycaemia * 1  1/163 (0.61%)  3/163 (1.84%) 
Hypernatraemia * 1  1/163 (0.61%)  0/163 (0.00%) 
Hypertriglyceridaemia * 1  0/163 (0.00%)  1/163 (0.61%) 
Hyperuricaemia * 1  0/163 (0.00%)  1/163 (0.61%) 
Hypocalcaemia * 1  1/163 (0.61%)  0/163 (0.00%) 
Hypokalaemia * 1  4/163 (2.45%)  7/163 (4.29%) 
Hyponatraemia * 1  2/163 (1.23%)  3/163 (1.84%) 
Hypophosphataemia * 1  1/163 (0.61%)  2/163 (1.23%) 
Metabolic Acidosis * 1  0/163 (0.00%)  1/163 (0.61%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/163 (1.23%)  0/163 (0.00%) 
Arthritis * 1  1/163 (0.61%)  0/163 (0.00%) 
Back Pain * 1  2/163 (1.23%)  1/163 (0.61%) 
Musculoskeletal Chest Pain * 1  0/163 (0.00%)  4/163 (2.45%) 
Musculoskeletal Pain * 1  1/163 (0.61%)  1/163 (0.61%) 
Nervous system disorders     
Ageusia * 1  0/163 (0.00%)  1/163 (0.61%) 
Dizziness * 1  1/163 (0.61%)  1/163 (0.61%) 
Dizziness Exertional * 1  0/163 (0.00%)  1/163 (0.61%) 
Dizziness Postural * 1  0/163 (0.00%)  2/163 (1.23%) 
Dysgeusia * 1  1/163 (0.61%)  1/163 (0.61%) 
Headache * 1  8/163 (4.91%)  8/163 (4.91%) 
Intercostal Neuralgia * 1  0/163 (0.00%)  1/163 (0.61%) 
Presyncope * 1  1/163 (0.61%)  0/163 (0.00%) 
Psychomotor Hyperactivity * 1  1/163 (0.61%)  0/163 (0.00%) 
Psychiatric disorders     
Alcohol Withdrawal Syndrome * 1  1/163 (0.61%)  0/163 (0.00%) 
Delirium * 1  0/163 (0.00%)  1/163 (0.61%) 
Insomnia * 1  0/163 (0.00%)  1/163 (0.61%) 
Panic Attack * 1  0/163 (0.00%)  1/163 (0.61%) 
Restlessness * 1  1/163 (0.61%)  0/163 (0.00%) 
Renal and urinary disorders     
Chronic Kidney Disease * 1  0/163 (0.00%)  1/163 (0.61%) 
Dysuria * 1  1/163 (0.61%)  0/163 (0.00%) 
Haematuria * 1  2/163 (1.23%)  0/163 (0.00%) 
Proteinuria * 1  2/163 (1.23%)  0/163 (0.00%) 
Urinary Retention * 1  1/163 (0.61%)  1/163 (0.61%) 
Reproductive system and breast disorders     
Menstruation Irregular * 1  0/163 (0.00%)  1/163 (0.61%) 
Pelvic Pain * 1  0/163 (0.00%)  1/163 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/163 (0.61%)  0/163 (0.00%) 
Atelectasis * 1  1/163 (0.61%)  0/163 (0.00%) 
Bronchospasm * 1  1/163 (0.61%)  1/163 (0.61%) 
Chronic Obstructive Pulmonary Disease * 1  1/163 (0.61%)  0/163 (0.00%) 
Cough * 1  2/163 (1.23%)  3/163 (1.84%) 
Dysphonia * 1  1/163 (0.61%)  1/163 (0.61%) 
Dyspnoea * 1  3/163 (1.84%)  1/163 (0.61%) 
Dyspnoea Exertional * 1  0/163 (0.00%)  1/163 (0.61%) 
Epistaxis * 1  3/163 (1.84%)  1/163 (0.61%) 
Hypersensitivity Pneumonitis * 1  1/163 (0.61%)  0/163 (0.00%) 
Hypoxia * 1  0/163 (0.00%)  1/163 (0.61%) 
Oropharyngeal Pain * 1  1/163 (0.61%)  0/163 (0.00%) 
Productive Cough * 1  1/163 (0.61%)  0/163 (0.00%) 
Pulmonary Mass * 1  1/163 (0.61%)  0/163 (0.00%) 
Pulmonary Oedema * 1  1/163 (0.61%)  0/163 (0.00%) 
Rhinorrhoea * 1  3/163 (1.84%)  0/163 (0.00%) 
Sputum Increased * 1  0/163 (0.00%)  1/163 (0.61%) 
Skin and subcutaneous tissue disorders     
Dermatitis Allergic * 1  1/163 (0.61%)  0/163 (0.00%) 
Night Sweats * 1  1/163 (0.61%)  0/163 (0.00%) 
Pruritus * 1  1/163 (0.61%)  0/163 (0.00%) 
Rash * 1  1/163 (0.61%)  1/163 (0.61%) 
Rash Erythematous * 1  0/163 (0.00%)  1/163 (0.61%) 
Rash Macular * 1  0/163 (0.00%)  1/163 (0.61%) 
Seborrhoeic Dermatitis * 1  0/163 (0.00%)  1/163 (0.61%) 
Skin Exfoliation * 1  0/163 (0.00%)  2/163 (1.23%) 
Urticaria * 1  0/163 (0.00%)  1/163 (0.61%) 
Vascular disorders     
Aortic Dilatation * 1  0/163 (0.00%)  1/163 (0.61%) 
Hypertension * 1  11/163 (6.75%)  3/163 (1.84%) 
Hypertensive Crisis * 1  0/163 (0.00%)  1/163 (0.61%) 
Hypotension * 1  1/163 (0.61%)  1/163 (0.61%) 
Phlebitis * 1  0/163 (0.00%)  1/163 (0.61%) 
Thrombophlebitis * 1  0/163 (0.00%)  1/163 (0.61%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters only.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Medical Leader
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03376321    
Other Study ID Numbers: CR108399
2017-002156-84 ( EudraCT Number )
63623872FLZ3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: December 12, 2017
First Posted: December 18, 2017
Results First Submitted: March 19, 2021
Results First Posted: April 14, 2021
Last Update Posted: April 14, 2021