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Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis

Study Purpose

The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adults ≥ 18 years of age.
  • - Approval from the patient's primary inpatient service.
  • - Hospitalized.
  • - Diagnosed with COVID-19 pneumonia.
  • - Positive test for active SARS-CoV-2 infection.
  • - Requiring supplemental oxygen ≥ 5LNC or ≥ 40% FiO2.
  • - Chest computed tomography (CT) at admission with < 10% pulmonary fibrosis.
  • - Ability to provide written informed consent on the part of the subject or, in the absence of decisional capacity of the subject, an appropriate surrogate (e.g. a legally authorized representative).

Exclusion Criteria:

  • - Known diagnosis of previous pulmonary fibrosis or an interstitial lung disease.
  • - Clinical features or known diagnosis of malignancy or active non-COVID-19 infection, including untreated latent tuberculosis.
  • - History of unstable or deteriorating cardiac disease (including myocardial infarction, coronary artery bypass surgery or angioplasty within the past 6 months, congestive heart failure requiring hospitalization within the past 6 months, or uncontrolled arrhythmia.
  • - Known history of hypersensitivity to sirolimus.
  • - History of unstable or deteriorating neurologic disease (including TIAs or stroke).
  • - Pregnant or lactating females.
Females of child bearing potential are required to have a negative pregnancy test prior to treatment and practice abstinence or prevent pregnancy by at least a barrier method of birth control.
  • - Investigational therapy for any indication within 28 days prior to treatment.
  • - Current treatment with any drugs that are strong inhibitors of CYP3A4.
  • - Tofacitinib.
  • - Clarithromycin.
  • - Telithromycin.
  • - Nefazodone.
  • - Itraconazole.
  • - Ketoconazole.
  • - Atazanavir.
  • - Darunavir.
  • - Indinavir.
  • - Lopinavir.
  • - Nelfinavir.
  • - Ritonavir.
  • - Saquinavir.
  • - Tipranavir.
  • - Inability or unwillingness to comply with the requirements for the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Chicago
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ayodeji Adegunsoye, MD, MS
Principal Investigator Affiliation University of Chicago
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID
Additional Details

Hospitalized patients with a diagnosis of COVID-19 pneumonia will be referred to the study team for potential recruitment. Initial screening will take place using the existing medical record and in collaboration with the treating team. The study consists of 3 randomly assigned arms of varying dosages of the study drug. All procedures, with the exception of drug dosing and option sample analysis, align with the subject's standard of care. Prior to initiating study drug, the subject's standard of care labs, imaging and oxygen requirements will be reviewed. Sirolimus will be administered as an oral medication. Subjects who are discharged prior to receiving 14 days of study drug will be provided with enough study drug to finish at home. On-study evaluation includes measurement of vital signs and laboratory studies before and after a patient has received sirolimus while inpatient. As part of routine care, subjects will be seen daily while in the hospital and will be monitored through blood tests for general health as well as renal function. Vital signs will be monitored daily while in the hospital, physical exams, assessment of COVID-19, and CT scans or chest x-rays as necessary for routine care. Subjects will return to clinic at 12 weeks for routine lab work and imaging as a part of study follow-up and will be assessed for pulmonary fibrosis at this time. Additionally, University of Chicago Medicine patients will have the option to allow investigators to use leftovers from tubes of blood drawn for clinical tests that would otherwise be discarded. This will apply to any blood collected during that respective hospital stay as well as up to 1 year after study enrollment.

Arms & Interventions


Active Comparator: Sirolimus 0.5mg

Subject will take Sirolimus 0.5mg orally daily for 14 days.

Active Comparator: Sirolimus 1mg

Subject will take Sirolimus 1mg orally daily for 14 days.

Active Comparator: Sirolimus 2mg

Subject will take Sirolimus 2mg orally daily for 14 days.


Drug: - Sirolimus

Triangular-shaped tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Chicago, Chicago, Illinois




University of Chicago

Chicago, Illinois, 60637

Site Contact

Ayodeji Adegunsoye, MD, MS