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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. Identifier: NCT04389840
Recruitment Status : Terminated (Limited enrollment)
First Posted : May 15, 2020
Last Update Posted : May 26, 2021
Information provided by (Responsible Party):

Brief Summary:
A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Lung Injury SARS-CoV-2 Drug: Dociparstat sodium Drug: Placebo Phase 2 Phase 3

Detailed Description:
The study is a randomized, double-blind, placebo-controlled, Phase 2/3 trial to evaluate the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. Eligible subjects will be those with confirmed COVID-19 who require hospitalization and supplemental oxygen therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 DSTAT:Placebo (First 12 patients) Randomized 2:1 DSTAT:Placebo (All other patients)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
Actual Study Start Date : June 3, 2020
Actual Primary Completion Date : May 20, 2021
Actual Study Completion Date : May 20, 2021

Arm Intervention/treatment
Experimental: Dociparstat sodium (DSTAT)
Dociparstat 4 mg/kg IV bolus on Day 1, followed by Dociparstat by continuous IV infusion for 24 hours daily for 7 days (starting on Day 1 and ending on Day 8 [168 hours])
Drug: Dociparstat sodium
Dociparstat is a glycosaminoglycan derived from porcine heparin.
Other Names:
  • CX-01
  • 2-0,3-0 desulfated heparin
  • ODSH

Placebo Comparator: Placebo
Placebo IV bolus on Day 1, followed by Placebo by continuous IV infusion for 24 hours daily for 7 days (starting on Day 1 and ending on Day 8 [168 hours])
Drug: Placebo
0.9% Normal Saline
Other Names:
  • Normal saline
  • Sodium chloride 0.9%
  • 0.9% Normal Saline

Primary Outcome Measures :
  1. Proportion of participants who are alive and free of invasive mechanical ventilation [ Time Frame: Through Day 28 ]
    Alive and free of invasive mechanical ventilation

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Through Day 28 ]
    Time to all-cause mortality

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Hospitalized for laboratory-documented COVID-19 disease (e.g., positive for SARS-CoV-2 via nasopharyngeal swab RT-PCR [or other commercial or public health assay]).
  2. Age ≥18 years and ≤85 years.
  3. Resting oxygen saturation (SaO2) of <94% while breathing ambient air.
  4. Score of 3 or 4 on the NIAID ordinal scale (requires supplemental oxygen or noninvasive ventilation).
  5. Provide informed consent to participate in the study (by participant or legally-acceptable representative).

Exclusion Criteria:

  1. Currently receiving invasive mechanical ventilation (e.g., via an endotracheal tube) (score of 2 on NIAID ordinal scale).
  2. Active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant (in the judgment of the investigator) gastrointestinal bleeding within the 3 weeks prior to randomization.
  3. Receiving any other investigational (non-approved) therapy for the treatment of COVID-19 or participating in the treatment period of any other therapeutic invention clinical study.
  4. Receiving systemic corticosteroids for a chronic condition.
  5. Receiving chronic anticoagulation with warfarin or direct oral anticoagulants (e.g., rivaroxaban, dabigatran, apixaban, edoxaban).
  6. Receiving or anticipated to require other systemic anticoagulation dosing at a therapeutic intensity. Prophylaxis of VTE using SC unfractionated heparin or enoxaparin is permitted with appropriate monitoring of coagulation status and within guidelines provided in the protocol.
  7. Receiving antiplatelet therapy, alone or in combination, including aspirin and other antiplatelet agents (e.g., clopidogrel, ticagrelor, and prasugrel), unless able to discontinue these agents at the time of randomization and to remain off these agents throughout the duration of the study intervention infusion period.
  8. Treatment with systemic (nonsteroid) immunomodulators or immunosuppressant medications, including but not limited to TNF inhibitors, anti-interleukin-1 agents, and Janus kinase (JAK) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.
  9. Severe chronic liver disease.
  10. Severe renal impairment.
  11. QTc >500 msec (or >530-550 msec in patients with QRS greater than >120 msec).
  12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN).
  13. Activated partial thromboplastin time (aPTT) >42 seconds.
  14. Thrombocytopenia with a platelet count <80,000/mm3.
  15. Evidence of clinical improvement in COVID-19 status including, but not limited to, a sustained reduction in oxygen requirements over the previous 48 hours, or extubated and/or no longer requiring mechanical ventilation following intubation for COVID-19.
  16. Any other condition, including abnormal laboratory values, that, in the judgment of the investigator, could put the participant at increased risk, or would interfere with the conduct or planned analysis of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04389840

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Advanced Pulmonary Research Institute/Wellington Regional Medical Center
Loxahatchee Groves, Florida, United States, 33470
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Louisiana
Our Lady of the Lake
Baton Rouge, Louisiana, United States, 70808
Tulane University
New Orleans, Louisiana, United States, 70112
University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Texas Health Harris Methodist Hospital Fort Worth
Dallas, Texas, United States, 76104
United States, Wisconsin
Ascension St. Francis Hospital
Milwaukee, Wisconsin, United States, 53215
Ascension All Saints Hospital
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chimerix Identifier: NCT04389840    
Other Study ID Numbers: CMX-DS-004
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chimerix:
Additional relevant MeSH terms:
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Respiratory Insufficiency
Lung Injury
Acute Lung Injury
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action