Back to resultsA Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Primary Purpose
Covid19, SARS-CoV-2 Infection
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GC4419
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID19, SARS-CoV-2 Infection
Eligibility 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
Sites / Locations
- University of Iowa
- Saint Louis University
- Mercy Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active GC4419
Placebo
Arm Description
Arm A
Arm B
Outcomes
Primary Outcome Measures
28 Day All-cause Mortality
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT04555096
First Posted
September 16, 2020
Last Updated
March 14, 2022
Sponsor
Galera Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04555096
Brief Title
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Participants are no longer receiving intervention
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galera Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Trial of GC4419 in Patients with Critical Illness due to COVID-19
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV-2 Infection
Keywords
COVID19, SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active GC4419
Arm Type
Experimental
Arm Description
Arm A
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm B
Intervention Type
Drug
Intervention Name(s)
GC4419
Other Intervention Name(s)
Avasopasem
Intervention Description
180 Minute IV Infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
180 Minute IV Infusion
Primary Outcome Measure Information:
Title
28 Day All-cause Mortality
Description
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Holmlund, MD
Organizational Affiliation
Study Chair
Official's Role
Study Chair
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33050459
Citation
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):971. doi: 10.3390/antiox9100971.
Results Reference
derived
Learn more about this trial
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
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