Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
37 participants
OBSERVATIONAL
2021-01-15
2023-05-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
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.
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.
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).
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Robert J Kaner, MD
Role: PRINCIPAL_INVESTIGATOR
WCM Associate Professor of Clinical Medicine Associate Attending
Craig S Conoscenti, MD
Role: PRINCIPAL_INVESTIGATOR
Boehringer Ingelheim
Nina Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Boehringer Ingelheim
Locations
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Washington University of St. Louis
St Louis, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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20-05022161
Identifier Type: -
Identifier Source: org_study_id
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