COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Initially, the trial will have two arms and subjects will be randomized to receive either active product or placebo as follows:
1. Remdesivir will be administered as a 200 mg intraveno
Sponsors
University of Minnesota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Admitted to a hospital with symptoms suggestive of COVID-19 infection 2. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures 3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures 4. Male or non-pregnant female adult =18 years of age at time of enrollment 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization. Note – 72 hours is not necessarily time from initial diagnosis. If =72 hours since positive PCR, the PCR may be repeated to assess eligibility 6. Illness of any duration, and at least one of the following: 6.1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR 6.2. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR 6.3. Requiring supplemental oxygen, OR 6.4. Requiring mechanical ventilation 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2. through Day 29
Exclusion criteria
Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal 2. Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis 3. Pregnancy or breastfeeding 4. Anticipated transfer to another hospital which is not a study site within 72 hours 5. Allergy to any study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery: day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Not hospitalized, no limitations on activities Measured from Day 1 to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical status measured using an eight-category ordinal scale from Day 3 to Day 29 2. Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) measured using patients’ medical records from Day 1 to Day 29 3. Cumulative incidence of serious adverse events (SAEs) measured using patients’ medical records from Day 1 to Day 29 4. Duration of hospitalization measured using patients’ medical records from Day 1 to Day 29 5. 14-day mortality measured using patients’ medical records from Day 1 to Day 15 6. 29-day mortality measured using patients’ medical records from Day 1 to Day 29 | — |
Countries
Denmark, England, Greece, United Kingdom
Outcome results
None listed