A Multicenter Adaptive Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Coronavirus Infection, Unspecified Site
-
Age: Between 18 - 110 Years
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Subjects who are admitted to a hospital with symptoms suggestive of COVID-19 infection.
- Subjects (or legally authorized representatives) able to provide written informed consent prior to initiation of any study procedures
- Subjects who understand and agree to comply with planned study procedures.
- Subjects who agree to the collection of oropharyngeal (OP) swabs.
- Subjects =18 years of age at time of enrollment.
- Subjects who have 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
- Subjects with illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR
- Requiring supplemental oxygen, OR
- Requiring mechanical ventilation
- Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception for the duration of the study
- Subjects agree to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29
You may not be eligible for this study if the following are true:
-
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
- Meets criteria for ordinal scale category 6 or 7 at the time of screening
- Subjects have a positive test for influenza virus during this current hospital admission
- Subjects with an estimated glomerular filtration rate (eGFR) < 30 mL/min
- ALT or AST > 5 times the upper limits of normal
- Total white cell blood cell count (WBC) <1500 cells/µL
- Platelet count <50,000/µL
- History of chronic liver disease
- Pregnancy or breast feeding
- Allergy to any study medication
- Has chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the PI, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study
- Received three or more doses of remdesivir, including the loading dose, outside of the study for COVID-19
- Received convalescent plasma or intravenous immunoglobulin [IVIg]) for the treatment of COVID-19
- Prior enrollment in ACTT-3
If you are registered as a volunteer, please login to the dashboard to send referrals.