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

Phase 2

Terminated

• Conditions: Covid19; SARS-CoV-2 Infection
• Interventions: Drug: GC4419; Drug: Placebo

• Registration Number: NCT04555096
• Lead Sponsor: Galera Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-18
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2022-03
• Results First Submitted: 2022-03-14
• Results First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Results First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active GC4419	GC4419	Arm A
Placebo	Placebo	Arm B

Primary Outcome Measures

Name	Time	Method
28 Day All-cause Mortality	28 days	Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.

Trial Locations

Locations (3)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Mercy Research; 🇺🇸 Saint Louis, Missouri, United States