Participants are no longer receiving intervention

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

Baseline analysis population is the same.

Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo

Study was terminated early due to the inability to enroll critically ill COVID 19 patients as the height of the pandemic was over and the sites that were open for enrollment to the clinical study were no longer treating these types of patients.