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

Description

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.

Conditions

Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID

Study Overview

Study Details

Study overview

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.

SECOVID: A Multi-center, Randomized, Dose-ranging Parallel-group Trial Assessing the Efficacy of Sirolimus in Hospitalized Patients With COVID-19 Pneumonia for the Prevention of Post-COVID Fibrosis

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

Condition
Pulmonary Fibrosis
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Chicago,

Ayodeji Adegunsoye, MD, MS, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2025-12