COVID-19 Respiratory Outcomes Registry

Summary

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.

Conditions

• Covid19

Interventions

OTHER

Questionnaires and Patient Reported Outcomes (PROs)

* EuroQol 5 Dimensional Quality of Life Questionnaire (EQ-5D). * St. George's Respiratory Questionnaire (SGRQ) * Impact of Events Scale Revised (IES-R) * Generalized Anxiety Disorder 7-Item (GAD-7) * Patient Health Questionnaire (PHQ-9)

DIAGNOSTIC_TEST

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

If required by the local site's COVID-19 guidelines, subjects should have the COVID-19 RT-PCR Nasal Swab collected at the beginning of the visit or within 5 days prior to the scheduled visit.

GENETIC

Blood Samples for Biomarkers

Venous blood will be collected using pre-labeled tubes.

DIAGNOSTIC_TEST

High Resolution Computed Tomography

Subjects will have HRCTs at Visits 1, 2, 3, and 4. Inpatient HRCT scans will be collected during the baseline visit (V0 or V1)

DIAGNOSTIC_TEST

Physical Exam and Vital Signs

A complete physical exam, including height, weight, general appearance, neck, lungs, cardiovascular system, abdomen, extremities, and skin will be performed at Visit 1.A brief physical exam will be completed at subsequent visits, including weight, general appearance, lungs, cardiovascular symptoms, extremities, and other body systems pertinent to the participants health status, at the discretion of the investigator. Blood pressure, heart rate, and oxygen saturation will be collected at all visits, prior to blood draws and after subjects have rested.

DIAGNOSTIC_TEST

Medical Research Council Sum Score

The Medical Research Council Sum Score (MRC-SS) is used globally to detect peripheral muscle strength and to help diagnose ICU-acquired muscle weakness. The MRC-SS ranging from 0 (complete paralysis) to 60 (normal).

DIAGNOSTIC_TEST

Hand Grip Strength

Each subject will have hand grip strength measured at each visit. This is being done in order to assess the maximum isometric strength of hand and forearm muscles.

DIAGNOSTIC_TEST

Spirometry

Spirometry will be assessed at Visits 1, 2, 3 and 4. Each site will use its own spirometry machine. Each subject should use the same machine at each visit and conduct measurements at approximately the same time. Before any testing, the maneuver should be demonstrated to the subject. The spirometry should be reviewed by the investigator.

DIAGNOSTIC_TEST

Diffusing Capacity of Carbon Monoxide

The site will use its own DLCO equipment for measurements at Visits, 1, 2, 3, and 4. The Single-breath DLCO maneuver will be carried out in accordance with the 2017 American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Subjects should use the same device at approximately that same time at each visit. The maneuver should be demonstrated to the subject prior to the test.

DIAGNOSTIC_TEST

6 Minute Walk Test

The 6 Minute Walk Test (6MWT) will assess exercise capacity and tolerance. 6MWTs will be conducted at Visits 1, 2, 3, and 4. The procedure of the 6MWT should be explained and demonstrated to the subject prior to the start of the test.

DIAGNOSTIC_TEST

Sit to Stand (STS) Measurement

The STS will be conducted at Visits 1, 2, 3, and 4 to assess the physical functioning of the adult participants.

Sponsors & Collaborators

• Boehringer Ingelheim

  collaborator INDUSTRY

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Robert J Kaner, MD · WCM Associate Professor of Clinical Medicine Associate Attending

• Craig S Conoscenti, MD · Boehringer Ingelheim

• Nina Patel, MD · Boehringer Ingelheim

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2023-05-09

Completion

2023-05-09

Countries

• United States

Study Locations