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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389840
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Chimerix

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: Dociparastat sodium Drug: Placebo Phase 2 Phase 3

Detailed Description:
The study is a 1:1 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)
Estimated Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 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: Dociparastat sodium
Dociparstat is a glycosaminoglycan derived from porcine heparin.
Other Names:
  • DSTAT
  • 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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤80 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. Receiving any other investigational (non-approved) therapy for the treatment of COVID-19
  3. Receiving or anticipated to require systemic corticosteroids
  4. Receiving chronic anticoagulation with warfarin or direct oral anticoagulants, with the exception of enoxaparin 40 mg SC once daily, or unfractionated heparin up to a maximum of 5000 units SC every 8 hours, for prophylaxis of deep vein thrombosis consistent with the current guidelines of the American Society of Hematology during COVID-19
  5. Treatment with systemic 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
  6. Severe chronic liver disease
  7. Severe renal impairment
  8. QTc >500 msec (or >530-550 msec in patients with QRS greater than >120 msec).
  9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN)
  10. Activated partial thromboplastin time (aPTT) >40 seconds
  11. Thrombocytopenia with a platelet count <80,000/mm3

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 ClinicalTrials.gov identifier (NCT number): NCT04389840


Contacts
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Contact: Marion Morrison, MD 919-313-2977 mmorrison@chimerix.com
Contact: Elizabeth MacLeod 919-287-6029 ext 211 emacleod@chimerix.com

Sponsors and Collaborators
Chimerix
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT04389840    
Other Study ID Numbers: CMX-DS-004
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
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:
COVID-19
ALI
SARS-CoV-2
Additional relevant MeSH terms:
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Respiratory Insufficiency
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Thoracic Injuries
Wounds and Injuries
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action