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

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