A Trial of GC4419 in Patients With Critical Illness Due to COVID-19

• Status: Terminated
• Trial end date: 2021-05-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galera Therapeutics, Inc.
• Treatments: Avasopasem manganese

Criteria

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