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Purpose

A Trial of GC4419 in Patients with Critical Illness due to COVID-19

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female subjects at least 18 years of age. 2. Ability to understand and the willingness to sign a written informed consent. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization 4. Requirement for intensive inpatient hospital care 5. Acute hypoxemic respiratory failure typifying ARDS 6. Adequate liver function 7. Use of effective contraception

Exclusion Criteria

  1. Expected survival for less than 48 hours after randomization 2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis 3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis 4. Requirement for extra-corporeal membrane oxygenation (ECMO) 5. Acute Myocardial Infarction (AMI) 6. Active bleeding requiring transfusion 7. Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2 8. Female patients who are pregnant or breastfeeding 9. Requirement for concurrent treatment with nitrates

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active GC4419 		Arm A
  • Drug: GC4419
    180 Minute IV Infusion
    Other names:
    • Avasopasem
Placebo Comparator
Placebo 		Arm B
  • Drug: Placebo
    180 Minute IV Infusion

Recruiting Locations

More Details

NCT ID
NCT04555096
Status
Terminated
Sponsor
Galera Therapeutics, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.