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

Galera Therapeutics

Status and phase: Terminated; Phase 2

Conditions: SARS-CoV-2 Infection; Covid19

Treatments: Drug: Placebo; Drug: GC4419

Study type: Interventional

Funder types: Industry

Identifiers

NCT04555096

COV-4419-201

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Active GC4419

Experimental group

Description:

Arm A

Treatment:

Drug: GC4419

Placebo

Placebo Comparator group

Description:

Arm B

Treatment:

Drug: Placebo