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NCT04555096 Clinical Trial

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

Covid19 Clinical Trial

Official title:
A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04555096
Other study ID # COV-4419-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 9, 2020
Est. completion date May 28, 2021

Study information
Verified date March 2022
Source Galera Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GC4419
180 Minute IV Infusion
• Placebo
180 Minute IV Infusion

Locations
Country Name City State
United States University of Iowa Iowa City Iowa
United States Mercy Research Saint Louis Missouri
United States Saint Louis University Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Galera Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28 Day All-cause Mortality Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy. 28 days
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