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Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia | Clinical Trials | Clareo Health

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Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

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

NCT04341675•University of Cincinnati

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 \<1,000/uL
•Age ≥ 18 years
•Completed informed consent

Exclusion Criteria

•Known allergy or hypersensitivity to sirolimus
•Inability or refusal to provide informed consent
•Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
•Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
•Pregnant women
•Breast feeding
•On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
•Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):
•* History of liver cirrhosis
•* End stage renal disease or need for renal replacement therapy
+4 more criteria

Locations (2)

Loyola University Medical Center

Chicago, Illinois, United States

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

April 24, 2020

Primary Completion Date

July 15, 2020

Completion Date

September 15, 2020

Last Updated

April 5, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Sirolimus

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

Inclusion Criteria

Exclusion Criteria

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