Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
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.
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