Covid19 Clinical Trial
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)
Verified date | March 2022 |
Source | Galera Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Trial of GC4419 in Patients with Critical Illness due to COVID-19
Status | Terminated |
Enrollment | 16 |
Est. completion date | May 28, 2021 |
Est. primary completion date | May 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
United States | Mercy Research | Saint Louis | Missouri |
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Galera Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28 Day All-cause Mortality | Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy. | 28 days |
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