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History of Changes for Study: NCT04389840
Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
Latest version (submitted August 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 13, 2020 None (earliest Version on record)
2 June 3, 2020 Recruitment Status, Study Status and Contacts/Locations
3 June 4, 2020 Contacts/Locations and Study Status
4 June 25, 2020 Eligibility and Study Status
5 July 14, 2020 Contacts/Locations and Study Status
6 July 24, 2020 Contacts/Locations and Study Status
7 August 6, 2020 Contacts/Locations and Study Status
8 August 16, 2020 Contacts/Locations and Study Status
9 August 24, 2020 Eligibility and Study Status
10 September 18, 2020 Contacts/Locations and Study Status
11 September 30, 2020 Contacts/Locations and Study Status
12 February 16, 2021 Contacts/Locations, Arms and Interventions, Study Design, Study Status and Study Description
13 May 24, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 May 27, 2022
Quality Control Review has not concluded Returned: June 22, 2022
Arms and Interventions, Study Status, Outcome Measures, Study Design, Study Description, Document Section, References, Contacts/Locations, Eligibility and Conditions
15 August 8, 2022 Study Status, Outcome Measures, Baseline Characteristics, Participant Flow, Document Section
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Study NCT04389840
Submitted Date:  May 13, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CMX-DS-004
Brief Title: Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: May 2020
Primary Completion: February 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: May 13, 2020
First Submitted that
Met QC Criteria:
May 13, 2020
First Posted: May 15, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 13, 2020
Last Update Posted: May 15, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Chimerix
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: COVID-19
Acute Lung Injury
SARS-CoV-2
Keywords: COVID-19
ALI
SARS-CoV-2
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Randomized 1:1
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 524 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Marion Morrison, MD
Telephone: 919-313-2977
Email: mmorrison@chimerix.com
Central Contact Backup: Elizabeth MacLeod
Telephone: 919-287-6029 Ext. 211
Email: emacleod@chimerix.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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