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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Sirolimus

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.