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
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Infections
• SARS-CoV-2 Infection

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