ACTIVE_NOT_RECRUITING

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

Conditions

Pulmonary Fibrosis COVID-19 Pneumonia Long COVID SECOVID Sirolimus Rapamune Post-COVID Fibrosis PASC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-07-09

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04948203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Principal Investigator

Ayodeji Adegunsoye, MD, MS

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Ayodeji Adegunsoye, MD, MS, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-09

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-07-09

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

SECOVID
Sirolimus
Rapamune
Post-COVID Fibrosis
PASC

Additional Relevant MeSH Terms

Pulmonary Fibrosis
COVID-19 Pneumonia
Long COVID