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

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ClinicalTrials.gov Identifier: NCT04555096

Recruitment Status : Terminated (Participants are no longer receiving intervention)

First Posted : September 18, 2020

Results First Posted : March 18, 2022

Last Update Posted : March 18, 2022

Sponsor:

Information provided by (Responsible Party):

Galera Therapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Covid19 SARS-CoV-2 Infection	Drug: GC4419 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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)
Actual Study Start Date :	September 9, 2020
Actual Primary Completion Date :	May 28, 2021
Actual Study Completion Date :	May 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active GC4419 Arm A	Drug: GC4419 180 Minute IV Infusion Other Name: Avasopasem
Placebo Comparator: Placebo Arm B	Drug: Placebo 180 Minute IV Infusion

Outcome Measures

Primary Outcome Measures :

28 Day All-cause Mortality [ Time Frame: 28 days ]
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555096

Locations

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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Mercy Research
Saint Louis, Missouri, United States, 63141

Sponsors and Collaborators

Galera Therapeutics, Inc.

Investigators

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Study Chair:	Jon Holmlund, MD	Study Chair

Study Documents (Full-Text)

Documents provided by Galera Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan [PDF] March 8, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karlsson JOG, Jynge P, Ignarro LJ. May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients? Antioxidants (Basel). 2020 Oct 10;9(10). pii: E971. doi: 10.3390/antiox9100971.

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Responsible Party:	Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT04555096
Other Study ID Numbers:	COV-4419-201
First Posted:	September 18, 2020 Key Record Dates
Results First Posted:	March 18, 2022
Last Update Posted:	March 18, 2022
Last Verified:	March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Galera Therapeutics, Inc.:


COVID19 SARS-CoV-2 Infection

Additional relevant MeSH terms:

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Infections COVID-19 Critical Illness Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections	Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Avasopasem manganese Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

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