COVID-19 Respiratory Outcomes Registry
Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes
1 other identifier
observational
37
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2023
CompletedJuly 27, 2023
July 1, 2023
2.3 years
April 6, 2021
July 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen
Categorized after exploratory analysis as improved, stable or worsened fibrotic changes seen on chest HRCT.
48 Weeks
Secondary Outcomes (15)
Changes from baseline and evidence of disease progression seen on high resolution computed tomography
72 Weeks
Changes from baseline and evidence of disease progression on pulmonary function testing
72 weeks
Changes from baseline and evidence of disease progression seen on pulmonary function testing
72 weeks
Changes from baseline and evidence of disease progression see on pulmonary function testing
72 weeks
Changes from baseline and evidence of disease progression via 6 Minute Walk Test
72 weeks
- +10 more secondary outcomes
Study Arms (4)
Cohort 1
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
Cohort 2
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.
Cohort 3a
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).
Cohort 3b
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.
Interventions
* 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)
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.
Venous blood will be collected using pre-labeled tubes.
Subjects will have HRCTs at Visits 1, 2, 3, and 4. Inpatient HRCT scans will be collected during the baseline visit (V0 or V1)
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.
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).
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 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.
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.
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.
The STS will be conducted at Visits 1, 2, 3, and 4 to assess the physical functioning of the adult participants.
Eligibility Criteria
Subjects with a diagnosis of COVID-19 who require therapy with supplemental oxygen and who meet the inclusion and exclusion criteria will be eligible for participation in this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- Boehringer Ingelheimcollaborator
Study Sites (4)
Washington University of St. Louis
St Louis, Missouri, 63130, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Biospecimen
Plasma, serum, and RNA will be collected at baseline, week 4, week 24, week 36, and week 48 to identify biomarkers that may put patients with COVID-19 at greater risk for development and/or progression of chronic fibrotic interstitial lung disease (ILD). Blood for DNA will be collected at baseline to assess whether genetic factors may increase the risk for development and/or progression of chronic fibrotic interstitial lung disease (ILD).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Kaner, MD
WCM Associate Professor of Clinical Medicine Associate Attending
- PRINCIPAL INVESTIGATOR
Craig S Conoscenti, MD
Boehringer Ingelheim
- PRINCIPAL INVESTIGATOR
Nina Patel, MD
Boehringer Ingelheim
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
October 12, 2021
Study Start
January 15, 2021
Primary Completion
May 9, 2023
Study Completion
May 9, 2023
Last Updated
July 27, 2023
Record last verified: 2023-07