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. 30 subjects will be 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.
Drug: Sirolimus
Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.
Other Name: Rapamycin
Drug: Placebo
Matching placebo
Other Name: placebo capsules
Inclusion Criteria:
Subjects enrolled in the trial must meet all of the following criteria.
- Confirmed COVID-19 pneumonia
- Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
- Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count
Loyola University Medical Center
Chicago, Illinois, 60153
University of Cincinnati
Cincinnati, Ohio, 45267
Investigator: Davis Alexandria
Contact: 513-558-2187
Investigator: Nishant Gupta, MD
Nishant Gupta, MD
5135584831
guptans@ucmail.uc.edu
Nishant Gupta, MD
Principal Investigator
University of Cincinnati