Using Sirolimus to Prevent Pulmonary Fibrosis in COVID-19 Pneumonia Patients
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
This study is testing if the drug sirolimus can help prevent lung scarring in patients with COVID-19 pneumonia while they are in the hospital.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | Tofacitinib |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04948203 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sirolimus in reducing the risk of pulmonary fibrosis in hospitalized patients diagnosed with COVID-19 pneumonia. Participants will be randomly assigned to receive different dosages of sirolimus, while their standard care continues. The study will monitor vital signs, laboratory tests, and imaging to assess the drug's impact on lung health over a 12-week follow-up period. Patients discharged before completing the treatment will receive enough medication to finish at home.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with COVID-19 pneumonia requiring supplemental oxygen.
Not a fit: Patients with a known diagnosis of previous pulmonary fibrosis or interstitial lung disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of pulmonary fibrosis in patients recovering from COVID-19 pneumonia.
How similar studies have performed: While the use of sirolimus in this context is novel, other studies have explored its potential in various inflammatory conditions, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full 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.
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Ayodeji Adegunsoye, MD, MS — University of Chicago
- Study coordinator: Ayodeji Adegunsoye, MD, MS
- Email: deji@uchicago.edu
- Phone: 773-702-4844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.