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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Fibrosis; COVID-19 Pneumonia; Long COVID
• Intervention / Treatment: Drug: Sirolimus

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sirolimus 0.5mg; Subject will take Sirolimus 0.5mg orally daily for 14 days.	Drug: Sirolimus; Triangular-shaped tablet; Other Names: RAPAMUNE
Active Comparator: Sirolimus 1mg; Subject will take Sirolimus 1mg orally daily for 14 days.	Drug: Sirolimus; Triangular-shaped tablet; Other Names: RAPAMUNE
Active Comparator: Sirolimus 2mg; Subject will take Sirolimus 2mg orally daily for 14 days.	Drug: Sirolimus; Triangular-shaped tablet; Other Names: RAPAMUNE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Pulmonary Fibrosis as evidenced by CT scan	Number of patients with >10% pulmonary fibrosis on chest CT	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10% Threshold for Pulmonary Fibrosis evidenced by CT scan	Number of patients with >10% pulmonary fibrosis on chest CT	12 Weeks
Qualitative Fibrotic markers on chest CT	Number of patients with the presence or absence of chest CT imaging markers of fibrosis	12 Weeks
Quantitative Fibrosis Score on chest CT	Quantitative Fibrosis Score on chest CT	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.	84 Days
Pulmonary Function Test impairment	Number of subjects with the presence of abnormal indices of lung function tests	12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Rate of Liver Function Test abnormalities	Number of patients in a study arm who develop severe impairment of liver function tests exceeding three times the upper limit of normal	12 Weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Ayodeji Adegunsoye, MD, MS, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sirolimus; Rapamune; PASC; SECOVID; Post-COVID Fibrosis
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases, Interstitial; Fibrosis; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome; Pulmonary Fibrosis; Organic Chemicals; Macrolides; Lactones; Sirolimus
• Other Study ID Numbers: IRB21-0400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes