COVID-19 Respiratory Outcomes Registry

Completed

Conditions studied: Covid19

In brief

This is a 48-week, observational study looking to see if the inflammatory process of hypoxemic respiratory failure associated with COVID-19 leads to progressive pulmonary fibrosis. Inpatient, as well as outpatient adults with recent COVID-19 hospitalization will be recruited. Data from hospitalization will be collected and subjects will return to the center for follow-up visits. Subjects will undergo the following procedures: High Resolution Computed Tomography (HRCT) of the chest, Pulmonary Function Tests (PFT), Muscle Strength Measurement, and blood draw for biomolecular data such as biomarkers found in ribonucleic acid (RNA), deoxyribonucleic acid (DNA), serum, and plasma. Quality of Life (QoL) measurements will also be collected through the study.

Key facts

Study ID

NCT05074875

Run by

Weill Medical College of Cornell University

People needed

37

Starts

2021-01-15

Expected to finish

2023-05-09

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent consistent with International Conference on Harmonization Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study
• Male or female ≥ 18 years of age at the time of consent
• SARS-CoV-2 positive confirmed by a positive serology or PCR or antigen test
• COVID-19 induced hypoxemia or reduced oxygen saturation requiring treatment with supplemental oxygen.
• COVID-19 hospital discharge date or outpatient COVID-19 infection within 24 weeks of enrollment

You may not qualify if…

• Diagnosed with Fibrotic Interstitial Lung Disease (ILD) prior to COVID-19 infection.
• Prior treatment with an antifibrotic agent, including nintedanib or pirfenidone
• Pregnant women or women planning on becoming pregnant in the next 12 months
• Patients planned for discharge from the hospital to hospice
• Patients with significant cognitive impairment

Where it is running

• Washington University of St. Louis — St Louis, Missouri, United States
• New York University Langone Medical Center — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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