Pulmonary FibrosisPhase 2/3NCT04948203
Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis
A Phase 2/3 study testing Sirolimus in people with Pulmonary Fibrosis and COVID-19 Pneumonia, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID
- What is being tested?
- Sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Hospitalized patients with a diagnosis of COVID-19 pneumonia will be referred to the study team for potential recruitment. Initial screening will take place using the existing medical record and in collaboration with the treating team. The study consists of 3 randomly assigned arms of varying dosages of the study drug
All procedures, with the exception of drug dosing and option sample analysis, align with the subject's standard of care. Prior to initiating study drug, the subject's standard of care labs, imaging and oxygen requirements will be reviewed.
Sirolimus will be administered as an oral medication. Subjects who are discharged prior to receiving 14 days of study drug will be provided with enough study drug to finish at home.
On-study evaluation includes measurement of vital signs and laboratory studies before and after a patient has received sirolimus while inpatient. As part of routine care, subjects will be seen daily while in the hospital and will be monitored through blood tests for general health as well as renal function. Vital signs will be monitored daily while in the hospital, physical exams, assessment of COVID-19, and CT scans or chest x-rays as necessary for routine care.
Subjects will return to clinic at 12 weeks for routine lab work and imaging as a part of study follow-up and will be assessed for pulmonary fibrosis at this time.
Additionally, University of Chicago Medicine patients will have the option to allow investigators to use leftovers from tubes of blood drawn for clinical tests that would otherwise be discarded. This will apply to any blood collected during that respective hospital stay as well as up to 1 year after study enrollment.
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID
- Being tested
- Sirolimus
- Keywords
- SECOVID, Sirolimus, Rapamune, Post-COVID Fibrosis, PASC
- Medical subject headings
- Pulmonary Fibrosis, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called RAPAMUNE
Triangular-shaped tablet
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus 0.5mg | Active comparator | Subject will take Sirolimus 0.5mg orally daily for 14 days. Receives: Drug: Sirolimus |
| Sirolimus 1mg | Active comparator | Subject will take Sirolimus 1mg orally daily for 14 days. Receives: Drug: Sirolimus |
| Sirolimus 2mg | Active comparator | Subject will take Sirolimus 2mg orally daily for 14 days. Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Pulmonary Fibrosis as evidenced by CT scan
Number of patients with >10% pulmonary fibrosis on chest CT
Measured: 12 Weeks
Secondary outcomes (5)
10% Threshold for Pulmonary Fibrosis evidenced by CT scan
Number of patients with >10% pulmonary fibrosis on chest CT
Measured: 12 Weeks
Qualitative Fibrotic markers on chest CT
Number of patients with the presence or absence of chest CT imaging markers of fibrosis
Measured: 12 Weeks
Quantitative Fibrosis Score on chest CT
Quantitative Fibrosis Score on chest CT
Measured: 12 Weeks
Duration of Increased Supplemental Oxygen from Baseline
Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.
Measured: 84 Days
Pulmonary Function Test impairment
Number of subjects with the presence of abnormal indices of lung function tests
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start9 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayodeji Adegunsoye, MD, MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948203
- Sponsor's protocol ID
- IRB21-0400
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04948203
- Acronym / sponsor ID
- IRB21-0400
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID
- Keywords
- SECOVID, Sirolimus, Rapamune, Post-COVID Fibrosis, PASC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hospitalized patients with a diagnosis of COVID-19 pneumonia will be referred to the study team for potential recruitment. Initial screening will take place using the existing medical record and in collaboration with the treating team. The study consists of 3 randomly assigned arms of varying dosages of the study drug
All procedures, with the exception of drug dosing and option sample analysis, align with the subject's standard of care. Prior to initiating study drug, the subject's standard of care labs, imaging and oxygen requirements will be reviewed.
Sirolimus will be administered as an oral medication. Subjects who are discharged prior to receiving 14 days of study drug will be provided with enough study drug to finish at home.
On-study evaluation includes measurement of vital signs and laboratory studies before and after a patient has received sirolimus while inpatient. As part of routine care, subjects will be seen daily while in the hospital and will be monitored through blood tests for general health as well as renal function. Vital signs will be monitored daily while in the hospital, physical exams, assessment of COVID-19, and CT scans or chest x-rays as necessary for routine care.
Subjects will return to clinic at 12 weeks for routine lab work and imaging as a part of study follow-up and will be assessed for pulmonary fibrosis at this time.
Additionally, University of Chicago Medicine patients will have the option to allow investigators to use leftovers from tubes of blood drawn for clinical tests that would otherwise be discarded. This will apply to any blood collected during that respective hospital stay as well as up to 1 year after study enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sirolimus 0.5mg | Active comparator | Drug: SirolimusSubject will take Sirolimus 0.5mg orally daily for 14 days. |
| Sirolimus 1mg | Active comparator | Drug: SirolimusSubject will take Sirolimus 1mg orally daily for 14 days. |
| Sirolimus 2mg | Active comparator | Drug: SirolimusSubject will take Sirolimus 2mg orally daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: RAPAMUNETriangular-shaped tablet | Drug | Sirolimus 0.5mg, Sirolimus 1mg, Sirolimus 2mg |
Primary outcome
Prevalence of Pulmonary Fibrosis as evidenced by CT scan
Time frame: 12 Weeks
Number of patients with >10% pulmonary fibrosis on chest CT
5 secondary outcomes
10% Threshold for Pulmonary Fibrosis evidenced by CT scan
Time frame: 12 Weeks
Qualitative Fibrotic markers on chest CT
Time frame: 12 Weeks
Quantitative Fibrosis Score on chest CT
Time frame: 12 Weeks
Duration of Increased Supplemental Oxygen from Baseline
Time frame: 84 Days
Pulmonary Function Test impairment
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayodeji Adegunsoye, MD, MS principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sirolimus in people with Pulmonary Fibrosis and COVID-19 Pneumonia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Pulmonary Fibrosis as evidenced by CT scan (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.