Covid19NCT05074875

COVID-19 Respiratory Outcomes Registry

An observational study of Covid19, run by Weill Medical College of Cornell University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Questionnaires and Patient Reported Outcomes (PROs), Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR) and Blood Samples for Biomarkers
How many people: 37 participants
Where: 4 sitesUnited States
Study dates: 15 Jan 2021to 9 May 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Baylor College of Medicine
Houston, Texas, 77030
New York University Langone Medical Center
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10065
Washington University of St. Louis
St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes

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.

Read the detailed description

This is a multi-center, observational, and prospective study collecting data on subjects who were hospitalized with hypoxemic respiratory failure associated with COVID-19 or patients who have evidence of an outpatient COVID-19 infection that have been treated with supplemental oxygen.

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: Covid19
Being tested: Questionnaires and Patient Reported Outcomes (PROs), Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), Blood Samples for Biomarkers, High Resolution Computed Tomography, Physical Exam and Vital Signs
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Questionnaires and Patient Reported Outcomes (PROs)Other
- 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)Diagnostic test
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 BiomarkersGenetic
Venous blood will be collected using pre-labeled tubes.
High Resolution Computed TomographyDiagnostic test
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 SignsDiagnostic test
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 ScoreDiagnostic test
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 StrengthDiagnostic test
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.
SpirometryDiagnostic test
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 MonoxideDiagnostic test
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 TestDiagnostic 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) MeasurementDiagnostic test
The STS will be conducted at Visits 1, 2, 3, and 4 to assess the physical functioning of the adult participants.

Study groups in NCT05074875
Study group	Role	What they receive
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 Receives: Other: Questionnaires and Patient Reported Outcomes (PROs); Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR); Genetic: Blood Samples for Biomarkers; Diagnostic Test: High Resolution Computed Tomography; Diagnostic Test: Physical Exam and Vital Signs; Diagnostic Test: Medical Research Council Sum Score; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Spirometry; Diagnostic Test: Diffusing Capacity of Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Diagnostic Test: Sit to Stand (STS) Measurement
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. Receives: Other: Questionnaires and Patient Reported Outcomes (PROs); Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR); Genetic: Blood Samples for Biomarkers; Diagnostic Test: High Resolution Computed Tomography; Diagnostic Test: Physical Exam and Vital Signs; Diagnostic Test: Medical Research Council Sum Score; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Spirometry; Diagnostic Test: Diffusing Capacity of Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Diagnostic Test: Sit to Stand (STS) Measurement
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). Receives: Other: Questionnaires and Patient Reported Outcomes (PROs); Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR); Genetic: Blood Samples for Biomarkers; Diagnostic Test: High Resolution Computed Tomography; Diagnostic Test: Physical Exam and Vital Signs; Diagnostic Test: Medical Research Council Sum Score; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Spirometry; Diagnostic Test: Diffusing Capacity of Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Diagnostic Test: Sit to Stand (STS) Measurement
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. Receives: Other: Questionnaires and Patient Reported Outcomes (PROs); Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR); Genetic: Blood Samples for Biomarkers; Diagnostic Test: High Resolution Computed Tomography; Diagnostic Test: Physical Exam and Vital Signs; Diagnostic Test: Medical Research Council Sum Score; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Spirometry; Diagnostic Test: Diffusing Capacity of Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Diagnostic Test: Sit to Stand (STS) Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 48 Weeks

Secondary outcomes (15)

Changes from baseline and evidence of disease progression seen on high resolution computed tomography
Percentage of subjects with evidence of disease progression by HRCT changes from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 Weeks
Changes from baseline and evidence of disease progression on pulmonary function testing
Relative change in Forced Vital Capacity percent predicted (FVC) from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Changes from baseline and evidence of disease progression seen on pulmonary function testing
Relative change in Diffusing Capacity of Carbon Monoxide percent predicted (DLCO) from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Changes from baseline and evidence of disease progression see on pulmonary function testing
Change in Maximum Inspiratory (PI Max) and Maximum Expiratory (PE Max) [cm H2O] from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Changes from baseline and evidence of disease progression via 6 Minute Walk Test
Change from baseline 6 Minute Walk Test (6MWT) distance (feet) from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Change in pre- and post- six minute walk test Borg Scale Dyspnea score from baseline and at 12, 24, and 48 weeks.
The top of the scale, "0 or nothing at all," means no breathlessness at all. The bottom of the scale, "10 or maximal," means the most severe breathlessness that you have ever experienced or could imagine experiencing from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Change in pre- and post- six minute walk test Borg Scale Fatigue score from baseline and at 12, 24, and 48 weeks.
The top of the scale, "0 or nothing at all," means no fatigue at all. The bottom of the scale, "10 or maximal," means the most severe fatigue that you have ever experienced or could imagine experiencing from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Changes from baseline and evidence of disease progression by Hand Grip Strength
Change in Hand Grip Strength value (kg) via hand dynamometer from baseline to 24, 36, 48 and 72 weeks.
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. EuroQol-5D (EQ-5D)
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
EuroQol-5D (EQ-5D) capture health status by asking 5 questions and by using a visual analog scale (0-100)
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. St. George's Respiratory Questionnaire (SGRQ)
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
St. George's Respiratory Questionnaire (SGRQ)
Patients respond to different prompts by checking off the amount of respiratory symptom occurrences.
Other prompts require true or false responses.
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Generalized Anxiety 7-Item (GAD-7)
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
Generalized Anxiety 7-Item (GAD-7) is a 7-item tool used to measure anxiety in patients. Each question is answered on a scale of 0-3
0- Not at all
1. Several Days
2. More than half the days
3. Nearly every day
Score indications:
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Patient Health Questionnaire 9 (PHQ-9)
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
Patient Health Questionnaire 9 (PHQ-9)
This is a 9-item questionnaire. Questions are answered from 0-3
0- Not at all
1. Several Days
2. More than half the days
3. Nearly every day
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- Impact of Events Scale Revised (IES-R)
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
Impact of Events Scale Revised (IES-R)
22 item patient reported outcome to measure affect of routine life stress, everyday traumas and acute stress, and potential Post Traumatic Stress Disorder (PTSD). Each question is answered from 0 to 4.
0- Not at all
1. A little bit
2. Moderately
3. Quite a bit
4. Extremely
Scores 24 or higher- PTSD is a clinical concern Scores 33 or higher- best cutoff for probable diagnosis of PTSD Scores 37 or higher- enough to suppress immune system
Measured: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- PROMIS-29 + 2 Profile
Change from baseline Quality of Life (QoL) questionnaires from baseline to 24, 36, 48 and 72 weeks.
PROMIS-29 + 2 Profile
31- item patient reported outcome to measure physical function, anxiety, depression, fatigue, sleep disturbance, social roles, cognition, and pain in adults.
Measured: 72 weeks
Examine the effects of COVID-19 on the presence of molecular biomarkers associated with Interstitial Lung Disease
Biomarkers prognostic for progression in PF patients incl. Soluble intercellular adhesion molecule-1 (sICAM-1), Surfactant protein D (SP-D), cancer antigen 125 (CA-125), cancer antigen (CA19-9), matrix metalloproteinase7 (MMP7), Krebs von den Lungen-6 (KL-6)
Biomarkers elevated in PF (vs age-matched controls) incl. cancer antigen 125 (CA-125), Carbohydrate antigen 19-9 (CA19-9), Krebs von den Lungen-6 (KL-6), Surfactant protein D (SP-D), C-C Motif Chemokine Ligand 18 (CCL18), matrix metalloproteinase7 (MMP7), von Willebrand factor (vWF)
Biomarkers elevated in COVID-19 patients incl. ferritin, Interleukin 6 (IL-6), C-reactive protein (CRP) , monocyte chemoattractant protein-1 (MCP1), Macrophage Inflammatory Protein-1 alpha (MIP1a), Vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), platelet derived growth factor (PDGF)
Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20219 May 2023

First posted12 Oct 2021
Study start15 Jan 2021
Primary completion9 May 2023
Study completion9 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05074875
Sponsor's protocol ID: 20-05022161
Status last verified: Jul 2023
First submitted: 6 Apr 2021
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes
ClinicalTrials.gov ID: NCT05074875
Acronym / sponsor ID: 20-05022161
Conditions: Covid19
Study type: Observational
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Boehringer Ingelheim
Study start: 15 Jan 2021 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 9 May 2023 (actual)
First posted: 12 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Cohort 1	–	Other: Questionnaires and Patient Reported Outcomes (PROs), Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), Genetic: Blood Samples for Biomarkers, Diagnostic Test: High Resolution Computed Tomography, Diagnostic Test: Physical Exam and Vital Signs, Diagnostic Test: Medical Research Council Sum Score, Diagnostic Test: Hand Grip Strength, Diagnostic Test: Spirometry, Diagnostic Test: Diffusing Capacity of Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Diagnostic Test: Sit to Stand (STS) MeasurementSubjects 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	–	Other: Questionnaires and Patient Reported Outcomes (PROs), Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), Genetic: Blood Samples for Biomarkers, Diagnostic Test: High Resolution Computed Tomography, Diagnostic Test: Physical Exam and Vital Signs, Diagnostic Test: Medical Research Council Sum Score, Diagnostic Test: Hand Grip Strength, Diagnostic Test: Spirometry, Diagnostic Test: Diffusing Capacity of Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Diagnostic Test: Sit to Stand (STS) MeasurementSubjects 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	–	Other: Questionnaires and Patient Reported Outcomes (PROs), Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), Genetic: Blood Samples for Biomarkers, Diagnostic Test: High Resolution Computed Tomography, Diagnostic Test: Physical Exam and Vital Signs, Diagnostic Test: Medical Research Council Sum Score, Diagnostic Test: Hand Grip Strength, Diagnostic Test: Spirometry, Diagnostic Test: Diffusing Capacity of Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Diagnostic Test: Sit to Stand (STS) MeasurementSubjects 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	–	Other: Questionnaires and Patient Reported Outcomes (PROs), Diagnostic Test: Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR), Genetic: Blood Samples for Biomarkers, Diagnostic Test: High Resolution Computed Tomography, Diagnostic Test: Physical Exam and Vital Signs, Diagnostic Test: Medical Research Council Sum Score, Diagnostic Test: Hand Grip Strength, Diagnostic Test: Spirometry, Diagnostic Test: Diffusing Capacity of Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Diagnostic Test: Sit to Stand (STS) MeasurementSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)	Other	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.	Diagnostic test	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Blood Samples for BiomarkersVenous blood will be collected using pre-labeled tubes.	Genetic	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
High Resolution Computed TomographySubjects 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Physical Exam and Vital SignsA 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Medical Research Council Sum ScoreThe 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Hand Grip StrengthEach 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
SpirometrySpirometry 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Diffusing Capacity of Carbon MonoxideThe 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
6 Minute Walk TestThe 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	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Sit to Stand (STS) MeasurementThe STS will be conducted at Visits 1, 2, 3, and 4 to assess the physical functioning of the adult participants.	Diagnostic test	Cohort 1, Cohort 2, Cohort 3a, Cohort 3b

Primary outcome

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
Time frame: 48 Weeks
Categorized after exploratory analysis as improved, stable or worsened fibrotic changes seen on chest HRCT.

15 secondary outcomes

Changes from baseline and evidence of disease progression seen on high resolution computed tomography
Time frame: 72 Weeks
Changes from baseline and evidence of disease progression on pulmonary function testing
Time frame: 72 weeks
Changes from baseline and evidence of disease progression seen on pulmonary function testing
Time frame: 72 weeks
Changes from baseline and evidence of disease progression see on pulmonary function testing
Time frame: 72 weeks
Changes from baseline and evidence of disease progression via 6 Minute Walk Test
Time frame: 72 weeks
Change in pre- and post- six minute walk test Borg Scale Dyspnea score from baseline and at 12, 24, and 48 weeks.
Time frame: 72 weeks
Change in pre- and post- six minute walk test Borg Scale Fatigue score from baseline and at 12, 24, and 48 weeks.
Time frame: 72 weeks
Changes from baseline and evidence of disease progression by Hand Grip Strength
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. EuroQol-5D (EQ-5D)
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. St. George's Respiratory Questionnaire (SGRQ)
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Generalized Anxiety 7-Item (GAD-7)
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Patient Health Questionnaire 9 (PHQ-9)
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- Impact of Events Scale Revised (IES-R)
Time frame: 72 weeks
Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- PROMIS-29 + 2 Profile
Time frame: 72 weeks
Examine the effects of COVID-19 on the presence of molecular biomarkers associated with Interstitial Lung Disease
Time frame: 72 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert J Kaner, MD principal investigator

WCM Associate Professor of Clinical Medicine Associate Attending

Craig S Conoscenti, MD principal investigator

Boehringer Ingelheim

Nina Patel, MD principal investigator

Boehringer Ingelheim

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Weill Medical College of Cornell University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05074875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.