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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE September 16, 2020
First Posted Date  ICMJE September 18, 2020
Results First Submitted Date  ICMJE March 14, 2022
Results First Posted Date  ICMJE March 18, 2022
Last Update Posted Date March 18, 2022
Actual Study Start Date  ICMJE September 9, 2020
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2022)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)		 28 day all-cause mortality 28 day all-cause mortality 28 day all-cause mortality [ Time Frame: 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Official Title  ICMJE A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)
Brief Summary A Trial of GC4419 in Patients with Critical Illness due to COVID-19
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: GC4419
    180 Minute IV Infusion
    Other Name: Avasopasem
  • Drug: Placebo
    180 Minute IV Infusion
Study Arms  ICMJE
  • Experimental: Active GC4419
    Arm A
    Intervention: Drug: GC4419
  • Placebo Comparator: Placebo
    Arm B
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 14, 2022)		 16
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2020)		 50
Actual Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04555096
Other Study ID Numbers  ICMJE COV-4419-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galera Therapeutics, Inc.
Study Sponsor  ICMJE Galera Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jon Holmlund, MD Study Chair
PRS Account Galera Therapeutics, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP