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

NCT04948203 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB21-0400
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Fibrosis; Long COVID; COVID-19 Pneumonia

Keywords

SECOVID; Sirolimus; Rapamune; Post-COVID Fibrosis; PASC

Outcome Measures

Primary Outcomes (1)

• Prevalence of Pulmonary Fibrosis as evidenced by CT scan

  Number of patients with \>10% pulmonary fibrosis on chest CT

  12 Weeks

Secondary Outcomes (5)

• 10% Threshold for Pulmonary Fibrosis evidenced by CT scan

  12 Weeks

• Qualitative Fibrotic markers on chest CT

  12 Weeks

• Quantitative Fibrosis Score on chest CT

  12 Weeks

• Duration of Increased Supplemental Oxygen from Baseline

  84 Days

• Pulmonary Function Test impairment

  12 Weeks

Other Outcomes (1)

• Safety - Rate of Liver Function Test abnormalities

  12 Weeks

Study Arms (3)

Sirolimus 0.5mg

ACTIVE COMPARATOR

Subject will take Sirolimus 0.5mg orally daily for 14 days.

Drug: Sirolimus

Sirolimus 1mg

ACTIVE COMPARATOR

Subject will take Sirolimus 1mg orally daily for 14 days.

Drug: Sirolimus

Sirolimus 2mg

ACTIVE COMPARATOR

Subject will take Sirolimus 2mg orally daily for 14 days.

Drug: Sirolimus

Interventions

Sirolimus DRUG

Triangular-shaped tablet

Also known as: RAPAMUNE

Sirolimus 0.5mg; Sirolimus 1mg; Sirolimus 2mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Post-Acute COVID-19 Syndrome

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Ayodeji Adegunsoye, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 1, 2021
• Study Start: July 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)