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 <1,000/uL
- Age ≥ 18 years
- Completed informed consent
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):
- History of liver cirrhosis
- End stage renal disease or need for renal replacement therapy
- Decompensated heart failure
- Known active tuberculosis or history of incompletely treated tuberculosis
- Uncontrolled systemic bacterial or fungal infections
- Active viral infection other than COVID-19
Loyola University Medical Center
Chicago, Illinois, United States
University of Cincinnati
Cincinnati, Ohio, United States
Nishant Gupta, MD
5135584831
guptans@ucmail.uc.edu
Nishant Gupta, MD, Principal Investigator
University of Cincinnati