Official Title
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)
Brief Summary

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.

Recruiting
COVID-19

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.
Sirolimus
Other Name: Rapamycin

Drug: Placebo
Matching placebo
Placebo
Other Name: placebo capsules

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Loyola University Medical Center
Chicago, Illinois, 60153

Active, not recruiting

University of Cincinnati
Cincinnati, Ohio, 45267

Recruiting

Investigator: Davis Alexandria
Contact: 513-558-2187
davis5ax@ucmail.uc.edu

Investigator: Nishant Gupta, MD

Contacts

Nishant Gupta, MD
5135584831
guptans@ucmail.uc.edu

Nishant Gupta, MD
Principal Investigator
University of Cincinnati

University of Cincinnati
NCT Number
MeSH Terms
Pneumonia
Sirolimus