RECRUITING

A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae

Conditions

COVID-19 SARS-CoV-2 Long COVID chronic lung sequelae post-acute

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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 purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection

Official Title

Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19

Quick Facts

Study Start:2024-01-10

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06006884

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
* Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease. * Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation). * Age ≥18 years at screening * PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49 * Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.	* Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease; * Active cigarette smoking, vaping or other inhalation use. * Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents; * \> 20 pack year smoking history. * History of chemotherapy or radiation therapy in the last two years; and pregnancy.

Inclusion Criteria

Exclusion Criteria

* Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.
* Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).
* Age ≥18 years at screening
* PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49
* Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.

* Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease;
* Active cigarette smoking, vaping or other inhalation use.
* Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents;
* \> 20 pack year smoking history.
* History of chemotherapy or radiation therapy in the last two years; and pregnancy.

Contacts and Locations

Principal Investigator

Robert Vassallo, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Robert Vassallo, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2024-01-10

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-01-10

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

COVID-19
SARS-CoV-2
Long COVID
chronic lung sequelae
post-acute

Additional Relevant MeSH Terms

COVID-19