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Trial record 1 of 1 for:    NCT04389840
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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 : Recruiting
First Posted : May 15, 2020
Last Update Posted : February 17, 2021
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: 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)
Estimated Enrollment : 525 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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 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:
  • 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

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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
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 ≤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 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

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Tejaswini Kulkarni, MD         
United States, Florida
Advanced Pulmonary Research Institute/Wellington Regional Medical Center Recruiting
Loxahatchee Groves, Florida, United States, 33470
Contact: Neal Warshoff, DO         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Joyce Gonzales, MD         
United States, Louisiana
Our Lady of the Lake Completed
Baton Rouge, Louisiana, United States, 70808
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Joseph Lasky, MD         
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Jyotsna Fuloria, MD         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Harold Friedman, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Caryn Morse, MD         
United States, Texas
Texas Health Harris Methodist Hospital Fort Worth Recruiting
Dallas, Texas, United States, 76104
Contact: Cheryl McDonald, MD         
United States, Virginia
Sentara Clinical Trials Withdrawn
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Ascension St. Francis Hospital Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Jonathan Treisman, MD         
Ascension All Saints Hospital Recruiting
Racine, Wisconsin, United States, 53405
Contact: Young Choi, MD         
Sponsors and Collaborators
Chimerix
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: February 17, 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:
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