CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Sirolimus +1 moredrug
Likely dose
Sirolimus 6mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04341675
NCT04341675Phase 2Completed

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

University of Cincinnati·interventional·Posted Apr 10, 2020·Updated Apr 5, 2024

In Brief

A Phase 2 clinical trial evaluating Sirolimus and Placebo for COVID-19. Completed, enrolled 32 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartApr 24, 2020
Primary CompletionJul 15, 2020
Study CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.2 years ago

Interventions

Sirolimusdrug

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.

Placebodrug

Matching placebo