Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

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