COVID-19 Respiratory Outcomes Registry

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: 6 Minute Walk Test; Diagnostic Test: Medical Research Council Sum Score; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Sit to Stand (STS) Measurement; Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR); Diagnostic Test: Physical Exam and Vital Signs; Diagnostic Test: Spirometry; Genetic: Blood Samples for Biomarkers; Diagnostic Test: High Resolution Computed Tomography; Other: Questionnaires and Patient Reported Outcomes (PROs); Diagnostic Test: Diffusing Capacity of Carbon Monoxide

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05074875

20-05022161

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Male or female ≥ 18 years of age at the time of consent
3. SARS-CoV-2 positive confirmed by a positive serology or PCR or antigen test
4. COVID-19 induced hypoxemia or reduced oxygen saturation requiring treatment with supplemental oxygen.
5. COVID-19 hospital discharge date or outpatient COVID-19 infection within 24 weeks of enrollment

Exclusion criteria

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

Trial design

37 participants in 4 patient groups

Cohort 1

Description:

Subjects with a diagnosis of hypoxemic respiratory failure associated with COVID-19 who meet the inclusion and exclusion criteria will be eligible for participation in this study. Cohort 1 subjects will undergo Visit 0 after informed consent is obtained. Eligible subjects will return for follow-up at Visits 2, 3, and 4, at weeks 24, 36, and 48 weeks

Treatment:

Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR)

Diagnostic Test: Diffusing Capacity of Carbon Monoxide

Diagnostic Test: High Resolution Computed Tomography

Other: Questionnaires and Patient Reported Outcomes (PROs)

Diagnostic Test: Hand Grip Strength

Diagnostic Test: Medical Research Council Sum Score

Diagnostic Test: 6 Minute Walk Test

Diagnostic Test: Spirometry

Genetic: Blood Samples for Biomarkers

Diagnostic Test: Physical Exam and Vital Signs

Diagnostic Test: Sit to Stand (STS) Measurement

Cohort 2

Description:

Subjects with a diagnosis of hypoxemic respiratory failure associated with COVID-19 who meet the inclusion and exclusion criteria will be eligible for participation in this study. Cohort 2 subjects will undergo Visit 1, within 4 (+/- 2) weeks of hospital discharge or outpatient infection, after informed consent is obtained. Eligible subjects will return for follow-up Visits 2, 3, and 4, at weeks 24, 36, and 48 weeks.

Treatment:

Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR)

Diagnostic Test: Diffusing Capacity of Carbon Monoxide

Diagnostic Test: High Resolution Computed Tomography

Other: Questionnaires and Patient Reported Outcomes (PROs)

Diagnostic Test: Hand Grip Strength

Diagnostic Test: Medical Research Council Sum Score

Diagnostic Test: 6 Minute Walk Test

Diagnostic Test: Spirometry

Genetic: Blood Samples for Biomarkers

Diagnostic Test: Physical Exam and Vital Signs

Diagnostic Test: Sit to Stand (STS) Measurement

Cohort 3a

Description:

Subjects with a diagnosis of hypoxemic respiratory failure associated with COVID-19 who meet the inclusion and exclusion criteria will be eligible for participation in this study. Cohorts 3a and 3b subjects will undergo their first study visit between 6 and 24 weeks of hospital discharge or outpatient infection, after informed consent is obtained. Participants should not be scheduled for chest HRCTs less than 12 weeks apart, however all subjects should have an HRCT done at Week 24 for analysis purposes. To prevent scheduling of HRCTs within less than 12 weeks. Subjects enrolled within ≤ 12 weeks of hospital discharge or outpatient COVID- 19 infection will undergo their first study visit at Visit 1 (Weeks 6-12).

Treatment:

Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR)

Diagnostic Test: Diffusing Capacity of Carbon Monoxide

Diagnostic Test: High Resolution Computed Tomography

Other: Questionnaires and Patient Reported Outcomes (PROs)

Diagnostic Test: Hand Grip Strength

Diagnostic Test: Medical Research Council Sum Score

Diagnostic Test: 6 Minute Walk Test

Diagnostic Test: Spirometry

Genetic: Blood Samples for Biomarkers

Diagnostic Test: Physical Exam and Vital Signs

Diagnostic Test: Sit to Stand (STS) Measurement

Cohort 3b

Description:

Subjects with a diagnosis of hypoxemic respiratory failure associated with COVID-19 who meet the inclusion and exclusion criteria will be eligible for participation in this study. Cohorts 3a and 3b subjects will undergo their first study visit between 6 and 24 weeks of hospital discharge or outpatient infection, after informed consent is obtained. Participants should not be scheduled for chest HRCTs less than 12 weeks apart, however all subjects should have an HRCT done at Week 24 for analysis purposes. To prevent scheduling of HRCTs within less than 12 weeks. Subjects enrolled ≥ 12 weeks from hospital discharge or outpatient COVID- 19 infection will undergo their first visit within 4 weeks before week 24. Subjects that are enrolled into Cohort 3 will be followed until Week 72.

Treatment:

Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR)

Diagnostic Test: Diffusing Capacity of Carbon Monoxide

Diagnostic Test: High Resolution Computed Tomography

Other: Questionnaires and Patient Reported Outcomes (PROs)

Diagnostic Test: Hand Grip Strength

Diagnostic Test: Medical Research Council Sum Score

Diagnostic Test: 6 Minute Walk Test

Diagnostic Test: Spirometry

Genetic: Blood Samples for Biomarkers

Diagnostic Test: Physical Exam and Vital Signs

Diagnostic Test: Sit to Stand (STS) Measurement