37
Participants
Start Date
January 15, 2021
Primary Completion Date
May 9, 2023
Study Completion Date
May 9, 2023
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)"
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.
Blood Samples for Biomarkers
Venous blood will be collected using pre-labeled tubes.
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)
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."
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).
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.
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.
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.
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."
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.
New York University Langone Medical Center, New York
Weill Cornell Medicine, New York
Washington University of St. Louis, St Louis
Baylor College of Medicine, Houston
Collaborators (1)
Boehringer Ingelheim
INDUSTRY
Weill Medical College of Cornell University
OTHER