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About
The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.
Enrollment
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Inclusion criteria
Subjects enrolled in the trial must meet all of the following criteria.
Exclusion criteria
Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:
Known allergy or hypersensitivity to sirolimus
Inability or refusal to provide informed consent
Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
Pregnant women
Breast feeding
On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups, including a placebo group
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Central trial contact
Nishant Gupta, MD
Data sourced from clinicaltrials.gov
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