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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
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 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

Arm Intervention/treatment
Experimental: Active GC4419
Arm A
Drug: GC4419
180 Minute IV Infusion

Placebo Comparator: Placebo
Arm B
Drug: Placebo
180 Minute IV Infusion




Primary Outcome Measures :
  1. 28 day all-cause mortality [ Time Frame: 28 days ]


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:

  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

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Last Update Posted: July 14, 2021
Last Verified: July 2021
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