NCT Number: NCT05074875
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.
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Notify Me18 year and older
All sexes
Observational
Washington University of St. Louis, St Louis, Missouri, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 Weeks
Categorized after exploratory analysis as improved, stable or worsened fibrotic changes seen on chest HRCT.
Time frame: 72 Weeks
Percentage of subjects with evidence of disease progression by HRCT changes from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 weeks
Relative change in Forced Vital Capacity percent predicted (FVC) from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 weeks
Relative change in Diffusing Capacity of Carbon Monoxide percent predicted (DLCO) from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 weeks
Change in Maximum Inspiratory (PI Max) and Maximum Expiratory (PE Max) [cm H2O] from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 weeks
Change from baseline 6 Minute Walk Test (6MWT) distance (feet) from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 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.
Time frame: 72 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.
Time frame: 72 weeks
Change in Hand Grip Strength value (kg) via hand dynamometer from baseline to 24, 36, 48 and 72 weeks.
Time frame: 72 weeks
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)
Time frame: 72 weeks
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.
Time frame: 72 weeks
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
Score indications:
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Time frame: 72 weeks
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
Time frame: 72 weeks
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
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
Time frame: 72 weeks
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.
Time frame: 72 weeks
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)
Weill Medical College of Cornell University
Other
Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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