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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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can sign the consent form myself or have someone legally authorized to do so.
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I am currently in the hospital.
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I am 18 years old or older.
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I have been diagnosed with COVID-19 pneumonia.

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

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

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
997 Previous Clinical Trials
817,638 Total Patients Enrolled
Ayodeji Adegunsoye, MD, MSPrincipal InvestigatorUniversity of Chicago

Media Library

Sirolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04948203 — Phase 2 & 3
Coronavirus Pneumonia Research Study Groups: Sirolimus 0.5mg, Sirolimus 1mg, Sirolimus 2mg
Coronavirus Pneumonia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of recruitment for this clinical research?

"Correct. Details found on clinicaltrials.gov verify that this medical study, which was originally posted on July 9th 2021, is actively recruiting participants. Approximately 60 people are needed to be recruited from a single site."

Answered by AI

Could you please elucidate the past experiments utilizing Sirolimus 1mg?

"Currently, there are 125 ongoing medical studies surrounding Sirolimus 1mg with 13 trials in Phase 3. Although most of these clinical trials take place in the city of Cincinnati, Ohio; globally speaking, 1074 different sites have active research for this drug."

Answered by AI

In what medical conditions is Sirolimus 1mg typically administered?

"Sirolimus 1mg is usually administered to combat organ transplant rejection and certain liver diseases. It also has potential for treating kidney disease and renal angiomyolipomas."

Answered by AI

Are there any vacant slots for participants in the experiment?

"Per the records on clinicaltrials.gov, this investigation is actively searching for participants with a commencement date of July 9th 2021 and most recent edition made on November 18th 2022."

Answered by AI
~4 spots leftby Jun 2024