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Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

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: NCT04389840
Recruitment Status : Terminated (Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual.)
First Posted : May 15, 2020
Results First Posted : August 30, 2022
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Chimerix

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Coronavirus Disease 2019 (COVID-19)
Acute Lung Injury
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Interventions Drug: Dociparstat sodium
Drug: Placebo
Enrollment 27
Recruitment Details  
Pre-assignment Details Study enrollment was terminated on 20 May 2021 due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual. At the time of termination, a total of 27 subjects of the planned 75 subjects had been enrolled, of which 26 subjects were treated and 22 subjects had completed the study across Cohorts 1, 2, and 3 (partial) of the Phase 2 portion of the study.
Arm/Group Title Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Hide Arm/Group Description Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Period Title: Overall Study
Started 6 6 8 4 2 1
Intent-to-Treat Analysis Set 6 6 8 4 2 1
Safety Analysis Set 6 6 8 3 [1] 2 1
Completed 4 5 8 3 1 1
Not Completed 2 1 0 1 1 0
Reason Not Completed
Adverse Event             0             0             0             1             0             0
Subject request and prohibited concomitant medication             2             0             0             0             1             0
Death             0             1             0             0             0             0
[1]
The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Arm/Group Title Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo Total
Hide Arm/Group Description Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Total of all reporting groups
Overall Number of Baseline Participants 6 6 8 3 2 1 26
Hide Baseline Analysis Population Description
Note: Baseline characteristics were evaluated for the Safety Analysis Set. The Intent-to-Treat Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 8 participants 3 participants 2 participants 1 participants 26 participants
50.5
(32 to 67)
63.0
(47 to 70)
62.0
(36 to 66)
62.0
(56 to 65)
39.5
(38 to 41)
41
(41 to 41)
57.0
(32 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 3 participants 2 participants 1 participants 26 participants
Female
6
 100.0%
4
  66.7%
2
  25.0%
3
 100.0%
0
   0.0%
0
   0.0%
15
  57.7%
Male
0
   0.0%
2
  33.3%
6
  75.0%
0
   0.0%
2
 100.0%
1
 100.0%
11
  42.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 3 participants 2 participants 1 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
2
  33.3%
2
  25.0%
2
  66.7%
0
   0.0%
1
 100.0%
9
  34.6%
White
4
  66.7%
4
  66.7%
4
  50.0%
1
  33.3%
1
  50.0%
0
   0.0%
14
  53.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   7.7%
NIAID Score (actual)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 3 participants 2 participants 1 participants 26 participants
3
2
  33.3%
5
  83.3%
2
  25.0%
0
   0.0%
2
 100.0%
1
 100.0%
12
  46.2%
4
4
  66.7%
1
  16.7%
6
  75.0%
3
 100.0%
0
   0.0%
0
   0.0%
14
  53.8%
[1]
Measure Description:

NIAID Score (actual) was calculated using hospitalization and ventilation status at the time of randomization. The ordinal scale is an assessment of the clinical status of the participant at a given time point. Scores 3 and 4 are as follows:

3. Hospitalized, on noninvasive ventilation or high flow oxygen devices. 4. Hospitalized, requiring supplemental oxygen.

Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 8 participants 3 participants 2 participants 1 participants 26 participants
32.5  (6.57) 33.9  (5.85) 31.0  (6.17) 36.4  (12.34) 28.6  (5.05) 45.4 [1]   (NA) 33.0  (6.85)
[1]
There was only 1 subject in this cohort.
1.Primary Outcome
Title Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28
Hide Description The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (<Day 25), whichever occurred first, by Day 28.
Time Frame Day 1 to Day 28 (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Note: This outcome measure was analyzed using the Intent-to-Treat (ITT) Analysis Set. In the ITT Analysis Set included 4 placebo-treated subjects for Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. This subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Arm/Group Title Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Hide Arm/Group Description:
Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Overall Number of Participants Analyzed 6 6 8 4 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
4
  66.7%
7
  87.5%
3
  75.0%
2
 100.0%
1
 100.0%
Time Frame From randomization through Day 28
Adverse Event Reporting Description Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
 
Arm/Group Title Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Hide Arm/Group Description Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
All-Cause Mortality
Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%)   0/8 (0.00%)   0/3 (0.00%)   0/2 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   3/6 (50.00%)   1/8 (12.50%)   0/3 (0.00%)   0/2 (0.00%)   0/1 (0.00%) 
General disorders             
Multiple organ dysfunction syndrome  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Infections and infestations             
COVID-19 pneumonia  1  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pneumonia bacterial  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Sepsis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Septic shock  1  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Respiratory failure  1  2/6 (33.33%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Acute respiratory distress syndrome  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Acute respiratory failure  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pulmonary embolism  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vascular disorders             
Deep vein thrombosis  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Peripheral artery thrombosis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Venous thrombosis limb  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Dociparstat Cohort 1 Placebo Cohort 2 Dociparstat Cohort 2 Placebo Cohort 3 Dociparstat Cohort 3 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   6/6 (100.00%)   5/8 (62.50%)   2/3 (66.67%)   1/2 (50.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders             
Leukocytosis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Cardiac disorders             
Atrial fibrillation  1  1/6 (16.67%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Sinus bradycardia  1  1/6 (16.67%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders             
Diarrhoea  1  1/6 (16.67%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Constipation  1  0/6 (0.00%)  2/6 (33.33%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Melaena  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
General disorders             
Chest pain  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Facial pain  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Multiple organ dysfunction  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Infections and infestations             
Oesophageal candidiasis  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pneumonia bacterial  1  1/6 (16.67%)  1/6 (16.67%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
COVID-19 pneumonia  1  0/6 (0.00%)  2/6 (33.33%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Genital herpes  1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Pneumonia staphylococcal  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Sepsis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Septic shock  1  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Investigations             
Alanine aminotransferase increased  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Aspartate aminotransferase increased  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Blood phosphorous decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders             
Fluid overload  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypocalcaemia  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypokalaemia  1  1/6 (16.67%)  1/6 (16.67%)  2/8 (25.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Lactic acidosis  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Metabolic acidosis  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hyperkalaemia  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypoglycaemia  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Nervous system disorders             
Encephalopathy  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Headache  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Visual field defect  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Dizziness  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Psychiatric disorders             
Anxiety  1  1/6 (16.67%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders             
Urinary retention  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Acute kidney injury  1  0/6 (0.00%)  3/6 (50.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pleural effusion  1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory failure  1  2/6 (33.33%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Acute respiratory distress syndrome  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Acute respiratory failure  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Cough  1  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Dyspnoea  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Epistaxis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Haemoptysis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hiccups  1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Nasal congestion  1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Pleuritic pain  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Productive cough  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pulmonary embolism  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Tachypnoea  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vascular disorders             
Deep vein thrombosis  1  1/6 (16.67%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypotension  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Peripheral artery thrombosis  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Thrombophlebitis  1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Venous thrombosis limb  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual, study enrollment was prematurely terminated on 20 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about docipartstat with regards to efficacy.
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.
Within 18 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publications may be delayed up to an additional 60 days to allow Sponsor to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Chimerix, Inc.
Phone: 919-806-1074 ext 101
EMail: dmoore@chimerix.com
Layout table for additonal information
Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT04389840    
Other Study ID Numbers: CMX-DS-004
First Submitted: May 13, 2020
First Posted: May 15, 2020
Results First Submitted: May 27, 2022
Results First Posted: August 30, 2022
Last Update Posted: August 30, 2022