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mTOR inhibitor

Sirolimus for Post-COVID Fibrosis Prevention

Phase 2 & 3
Recruiting
Led By Ayodeji Adegunsoye, MD, MS
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring supplemental oxygen ≥ 5LNC or ≥ 40% FiO2
Hospitalized
Must not have
History of unstable or deteriorating neurologic disease (including TIAs or stroke)
Clinical features or known diagnosis of malignancy or active non-COVID-19 infection, including untreated latent tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trialseeks to find out if a drug can stop COVID-19 pneumonia from leading to lung scarring.

Who is the study for?
Adults over 18 with COVID-19 pneumonia, needing oxygen support, and showing less than 10% lung fibrosis on a CT scan can join. They must be hospitalized, able to consent or have someone who can for them. Those with recent severe heart issues, sirolimus allergies, other serious health conditions, or women who are pregnant/lactating cannot participate.
What is being tested?
The trial is testing if Sirolimus can prevent lung scarring (pulmonary fibrosis) in patients hospitalized with COVID-19 pneumonia. It aims to see whether this drug reduces the chances of developing long-term lung damage after recovery from the virus.
What are the potential side effects?
Sirolimus may cause side effects like mouth sores, increased cholesterol levels, rash, diarrhea and lower blood cell counts which could raise infection risk. There might also be risks related to liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need extra oxygen of at least 5 liters per minute or 40% oxygen concentration.
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I am currently in the hospital.
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I have been diagnosed with COVID-19 pneumonia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had worsening or unstable brain or nerve conditions.
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I have cancer or an active infection that is not COVID-19, including untreated TB.
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I have not had serious heart problems or treatments in the last 6 months.
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I have been diagnosed with pulmonary fibrosis or interstitial lung disease.
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I am not taking drugs that strongly affect liver enzyme CYP3A4.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of Pulmonary Fibrosis as evidenced by CT scan
Secondary study objectives
10% Threshold for Pulmonary Fibrosis evidenced by CT scan
Duration of Increased Supplemental Oxygen from Baseline
Pulmonary Function Test impairment
+2 more
Other study objectives
Safety - Rate of Liver Function Test abnormalities

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Sirolimus 0.5mgActive Control1 Intervention
Subject will take Sirolimus 0.5mg orally daily for 14 days.
Group II: Sirolimus 1mgActive Control1 Intervention
Subject will take Sirolimus 1mg orally daily for 14 days.
Group III: Sirolimus 2mgActive Control1 Intervention
Subject will take Sirolimus 2mg orally daily for 14 days.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,326 Total Patients Enrolled
5 Trials studying Pulmonary Fibrosis
4,721 Patients Enrolled for Pulmonary Fibrosis
Ayodeji Adegunsoye, MD, MSPrincipal InvestigatorUniversity of Chicago

Media Library

Sirolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04948203 — Phase 2 & 3
Pulmonary Fibrosis Research Study Groups: Sirolimus 0.5mg, Sirolimus 1mg, Sirolimus 2mg
Pulmonary Fibrosis Clinical Trial 2023: Sirolimus Highlights & Side Effects. Trial Name: NCT04948203 — Phase 2 & 3
Sirolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948203 — Phase 2 & 3
~13 spots leftby Dec 2025
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