Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

NCT ID: NCT04341675

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-24
• Study Completion Date: 2020-09-15

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sirolimus

Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.

Group Type: ACTIVE_COMPARATOR

Sirolimus

Intervention Type: DRUG

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.

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

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.

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Other Intervention Names

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

Exclusion Criteria

Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:

• 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
• Decompensated heart failure
• Known active tuberculosis or history of incompletely treated tuberculosis
• Uncontrolled systemic bacterial or fungal infections
• Active viral infection other than COVID-19

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Nishant Gupta, MD, MS

Adjunct Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nishant Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Loyola University Medical Center

Chicago, Illinois, United States

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2020-0337

Identifier Type: -

Identifier Source: org_study_id