COVID-19 Respiratory Outcomes Registry

  • End date
    Dec 20, 2023
  • participants needed
  • sponsor
    Weill Medical College of Cornell University
Updated on 20 October 2021


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.


This is a multi-center, observational, and prospective study collecting data on subjects who were hospitalized with hypoxemic respiratory failure associated with COVID-19 or patients who have evidence of an outpatient COVID-19 infection that have been treated with supplemental oxygen.

A total of approximately 300 subjects will be enrolled in the study. Subjects will be enrolled into one of 3 cohorts.

Cohort 1: Inpatient Enrollment: Subjects enrolled while hospitalized for COVID-19, prior to discharge.

Cohort 2: Outpatient Enrollment: Subjects enrolled up to 4 weeks after discharge from hospitalization for COVID-19 or 4 weeks post their outpatient COVID -19 infection.

Cohort 3: Outpatient Enrollment: Subjects enrolled between 6 and 24 weeks after discharge from hospitalization for COVID-19 or 6 and 24 weeks post their outpatient COVID -19 infection. Cohort 3 will be sub-divided into 3a and 3b depending on the timepoint of enrollment.

After signing the Informed Consent Form, the screening visit will be performed. Screening and enrollment can occur at Visit 0 (inpatient) or Visit 1 (outpatient). Following completion of Visit 0 or 1 the subjects' data will be assessed by the investigator to confirm eligibility and a decision will be made if the patient is to be enrolled. If not the reason for non-enrollment will be listed in the trial log.

Each subject will either have a total of 4 or 5 visits, depending on if subjects complete enrollment while still admitted to the hospital (Visit 0) or at Visit 1. At weeks 4, 24, 36, 48, all subjects will complete questionnaires, have physical exams, spirometry test with DLCO, HRCTs, 6MWTs, blood draws, and review of medical history since the previous visit.

The primary analysis of this study will be performed once the last enrolled subject reaches Week 48. At that time, there will be a data-base lock. Unless otherwise noted, Visit 1 is treated as baseline measurement. In addition, for patients enrolled at discharge, a second set of analysis will be performed treating Visit 0 as baseline for the measurements collected at Visit 0.

Aim 1: To identify whether the trajectory of COVID-19 associated respiratory failure results in progressive pulmonary fibrosis with clinical features or biomolecular changes.

Aim 2: To identify biomarkers that may indicate those patients at risk for developing a chronic fibrotic HRCT pattern that may go on to progression.

Condition COVID19
Treatment spirometry, hand grip strength, 6 Minute Walk Test, Blood Samples for Biomarkers, Questionnaires and Patient Reported Outcomes (PROs), Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), High Resolution Computed Tomography, High Resolution Computed Tomography, Physical Exam and Vital Signs, Medical Research Council Sum Score, Diffusing Capacity of Carbon Monoxide, Sit to Stand (STS) Measurement
Clinical Study IdentifierNCT05074875
SponsorWeill Medical College of Cornell University
Last Modified on20 October 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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