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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
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.
Matching placebo
Loyola University Medical Center
Chicago, Illinois, United States
University of Cincinnati
Cincinnati, Ohio, United States
Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP\* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. \* CPAP use for known obstructive sleep apnea will not be considered as disease progression.
Time frame: 28 days
Percentage of Patients Surviving to Hospital Discharge
Survival to hospital discharge
Time frame: 28 days
Drug Safety Profile
Number of patients with adverse events
Time frame: 28 days
Duration of Hospital Stay
Length of hospitalization is measured as the number of days in the hospital from the date of randomization until the date of discharge or death from any cause, whichever came first, assessed up to 28 days post discharge.
Time frame: days
Number of Patients Who Require Initiation of Off-label Therapies
Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians
Time frame: 28 days
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