COVID-19 Respiratory Outcomes Registry

CompletedOBSERVATIONAL
Enrollment

37

Participants

Timeline

Start Date

January 15, 2021

Primary Completion Date

May 9, 2023

Study Completion Date

May 9, 2023

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.

Trial Locations (4)

10016

New York University Langone Medical Center, New York

10065

Weill Cornell Medicine, New York

63130

Washington University of St. Louis, St Louis

77030

Baylor College of Medicine, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER

NCT05074875 - COVID-19 Respiratory Outcomes Registry | Biotech Hunter | Biotech Hunter