Can a transplant drug stop COVID lung damage?
NCT ID NCT04948203
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the drug sirolimus can prevent lung scarring (fibrosis) in people hospitalized with severe COVID-19 pneumonia. About 60 adults who need extra oxygen will receive sirolimus to see if it reduces the chance of long-term lung damage. The goal is to find a way to protect lungs after a serious COVID-19 infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sirolimus (also known as rapamycin)
- What this could lead to
- If it works, this could point toward a treatment to prevent permanent lung scarring after severe COVID-19 pneumonia.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. Sirolimus can have side effects like increased infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2021
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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