NCT04341675

Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2020-04-24
• Primary completion: 2020-07-15
• Completion: 2020-09-15
• First posted: 2020-04-10
• Last updated: 2024-04-05
• Results posted: 2024-04-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study