drugset / Trial / NCT04341675

Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

NCT04341675

Phase 2 Completed 32 enrolled University of Cincinnati
RandomizedParallel-groupQuadruple-blindTreatment

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. 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.

Timeline

Start
2020-04-24
Primary completion
2020-07-15
Completion
2020-09-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sirolimus Small molecule 2 mg Oral

Indications