Clinical trial
Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes
Name
20-05022161
Description
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 arms
Trial start
2021-01-15
Estimated PCD
2023-05-09
Trial end
2023-05-09
Status
Completed
Treatment
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)
Arms:
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Blood Samples for Biomarkers
Venous blood will be collected using pre-labeled tubes.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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)
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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).
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
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.
Arms:
Cohort 1, Cohort 2, Cohort 3a, Cohort 3b
Size
37
Primary endpoint
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
48 Weeks
Eligibility criteria
Inclusion Criteria:
1. 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
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:
1. Diagnosed with Fibrotic Interstitial Lung Disease (ILD) prior to COVID-19 infection.
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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).'}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2023-07-27
1 organization
Organization
Weill Medical College of Cornell University