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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555096
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : September 22, 2020
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)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 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


Contacts
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Contact: Amanda Sanders 610-725-1500 info@galeratx.com
Contact: Jon Holmlund, MD 610-725-1500 info@galeratx.com

Locations
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United States, Missouri
Mercy Research Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Analyn Howells    314-251-1481      
Principal Investigator: George Matuschak, MD         
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: September 22, 2020
Last Verified: September 2020
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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Infection
Critical Illness
Disease Attributes
Pathologic Processes