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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Covid19, SARS-CoV-2 Infection

In brief

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

Key facts

Study ID

NCT04555096

Run by

Galera Therapeutics, Inc.

People needed

16

Starts

2020-09-09

Expected to finish

2021-05-28

Last updated by the study team

2022-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Saint Louis University — St Louis, Missouri, United States
• Mercy Research — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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