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

Primary Purpose

Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sirolimus

About this trial

This is an interventional prevention trial for Pulmonary Fibrosis focused on measuring SECOVID, Sirolimus, Rapamune, Post-COVID Fibrosis, PASC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Sirolimus 0.5mg

Sirolimus 1mg

Sirolimus 2mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Prevalence of Pulmonary Fibrosis as evidenced by CT scan

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

Secondary Outcome Measures

10% Threshold for Pulmonary Fibrosis evidenced by CT scan

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

Qualitative Fibrotic markers on chest CT

Number of patients with the presence or absence of chest CT imaging markers of fibrosis

Quantitative Fibrosis Score on chest CT

Duration of Increased Supplemental Oxygen from Baseline

Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.

Pulmonary Function Test impairment

Number of subjects with the presence of abnormal indices of lung function tests

Full Information

NCT ID

NCT04948203

First Posted

June 29, 2021

Last Updated

November 18, 2022

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04948203

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 9, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Fibrosis, COVID-19 Pneumonia, Long COVID

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sirolimus 0.5mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sirolimus 1mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sirolimus 2mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

RAPAMUNE

Intervention Description

Triangular-shaped tablet

Primary Outcome Measure Information:

Title

Prevalence of Pulmonary Fibrosis as evidenced by CT scan

Description

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

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

10% Threshold for Pulmonary Fibrosis evidenced by CT scan

Description

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

Time Frame

12 Weeks

Title

Qualitative Fibrotic markers on chest CT

Description

Number of patients with the presence or absence of chest CT imaging markers of fibrosis

Time Frame

12 Weeks

Title

Quantitative Fibrosis Score on chest CT

Description

Quantitative Fibrosis Score on chest CT

Time Frame

12 Weeks

Title

Duration of Increased Supplemental Oxygen from Baseline

Description

Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.

Time Frame

84 Days

Title

Pulmonary Function Test impairment

Description

Number of subjects with the presence of abnormal indices of lung function tests

Time Frame

12 Weeks

Other Pre-specified Outcome Measures:

Title

Safety - Rate of Liver Function Test abnormalities

Description

Number of patients in a study arm who develop severe impairment of liver function tests exceeding three times the upper limit of normal

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayodeji Adegunsoye, MD, MS

Phone

773-702-4844

deji@uchicago.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Spring Maleckar

Phone

773.834.4053

smaleckar@bsd.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayodeji Adegunsoye, MD, MS

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayodeji Adegunsoye, MD, MS

Phone

773-702-4844

aadegunsoye@medicine.bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Spring Maleckar

Phone

773.834.4053

smaleckar@bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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