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

IRB21-0400

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.

2021-07-09

2024-06-01

2024-06-01

Recruiting

Early phase I

60

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-11-30