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

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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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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
Arm/Group Description	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...
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.

Baseline Characteristics

Arm/Group Title		Cohort 1 Dociparstat	Cohort 1 Placebo	Cohort 2 Dociparstat	Cohort 2 Placebo	Cohort 3 Dociparstat	Cohort 3 Placebo	Total
Arm/Group Description		Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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.

Outcome Measures

1.Primary Outcome


Title	Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28
Description	The primary efficacy endpoint was to be the proportion of participants...
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)

Outcome Measure Data

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
Arm/Group Description:	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...
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%

Adverse Events

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
Arm/Group Description	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received placebo IV bolus ...	Subjects received 4 mg/kg of docipa...	Subjects received 4 mg/kg of docipa...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

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.

More Information

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

Publications:

Lasky JA, Fuloria J, Morrison ME, Lanier R, Naderer O, Brundage T, Melemed A. Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19. Adv Ther. 2021 Jan;38(1):782-791. doi: 10.1007/s12325-020-01539-z. Epub 2020 Oct 27.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

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

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