Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Functional, imaging, and respiratory evaluation in CORAL (FIRE CORAL)
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Accession Number
HLB02822424a
Study Type
Epidemiology Study
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
June 2021 to May 2022
NHLBI Division
DLD
Dataset(s) Last Updated
March 1, 2024
Study Website
https://petalnet.org/studies.html
Clinical Trial URLs
N/A
Primary Publication URLs
N/A
Related Studies
PETAL-BLUE CORAL,
PETAL-RED CORAL
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions Yes
Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes
Genetic Use Of Specimens Allowed? Yes, For Some Specimens
Genetic Use Area Of Research Restrictions Yes
Specific Consent Restrictions
Use of specimens in non-genetic and/or genetic research is tiered to 1) research related to COVID-19 and/or 2) research involved with other medical conditions. Specimens may not be used directly to produce commercial products.
Objectives
To examine the recovery from COVID-19 disease following acute hospitalization with an emphasis on functional, imaging, and respiratory evaluation, and assess the feasibility of conducting a larger study to evaluate variables associated with differential recovery.
Background
The BLUE CORAL study was intended to address the knowledge gaps and provide critical data to help guide clinical care, public health, and scientific efforts regarding SARS-CoV-2 (COVID-19) recovery. The understanding and treatment of long-term sequelae of COVID-19, referred to variously as post-acute sequelae of COVID-19 (PASC), post-acute COVID, Long COVID, or long-haul COVID, is fundamental to patient recovery. These long-term consequences are common and increasingly recognized, although heterogeneous in manifestation, and can result in a failure to return to baseline level of health. At the time of the FIRE CORAL study, there were limited studies that collected objective assessments following hospital discharge for a wide spectrum of patients surviving COVID-19.
Participants
FIRE CORAL enrolled adult participants as a subset of those enrolled in the BLUE CORAL study with a recent COVID-19 hospitalization and that completed the 1- or 3-month post-hospital telephone long-term outcomes assessment. The target enrollment for this pilot study cohort was 80 participants.
Design
FIRE CORAL was a multicenter prospective cohort study of participants recovering from COVID-19 disease with in-person follow-up, as an extension of the BLUE CORAL study. The study consisted of a battery of assessments objectively measuring pulmonary function, abnormalities on lung imaging, and functional status. Participants were to attend and perform initial in-person testing at 3 to 9 months after hospital discharge. Participants with abnormal findings on pulmonary function testing or chest imaging during their initial assessment or those with persistent respiratory symptoms were eligible to repeat study procedures 3 months later with a subsequent visit at 12 months. All participants were invited to return for in-person follow-up at 12 months after hospital discharge. Assessments included high-resolution chest CT scan without contrast, spirometry, lung volume assessment, diffusing capacity measured by single breath measurement, Six Minute Walk Test, Short Physical Performance Battery, St. George’s Respiratory Questionnaire, and Functional Assessment of Chronic Illness Therapy-Fatigue scale. Demographic and hospitalization data are available as part of the BLUE CORAL study.
The primary aim of the FIRE CORAL study was to examine the feasibility of conducting rigorous in-person follow-up testing of participants discharged from the hospital following COVID-19 illness to assist with planning for a larger study to evaluate variables associated with differential recovery. The secondary aim was to describe the pulmonary, imaging, and functional recovery following COVID-19 hospitalization in a diverse population of patients.
Mayer KP, Palakshappa JA, Peltan ID, Andrew JS, Gundel SJ, Ringwood NJ, Mckeehan J, Hope AA, Rogers AJ, Biehl M, Hayden DL, Caldwell E, Mehkri O, Lynch DJ, Burham EL, Hough CL, Jolley SE; NHLBI PETAL Network. Functional, imaging, and respiratory evaluation (FIRE) of patients post-hospitalization for COVID-19: protocol for a pilot observational study. Pilot Feasibility Stud. 2022 Sep 19;8(1):212. doi: 10.1186/s40814-022-01151-8. PMID: 36123599; PMCID: PMC9483889.
Additional Details
50 Subjects
| Total Subjects |
---|---|
Male | 27 |
Female | 23 |
| Total Subjects |
---|---|
BLACK | 6 |
HISPANIC | 15 |
MISSING/UNKNOWN/REFUSED | 4 |
OTHER | 3 |
WHITE | 22 |
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
Plasma, Whole blood for the purpose of DNA extraction, Whole blood for the purpose of RNA extraction
04/03/2024
All specimens are unthawed
04/03/2024
| Plasma | Whole Blood, DNA Extraction | Whole Blood, RNA Extraction | Total Vials |
---|---|---|---|---|
Post Discharge Visit 1 | 188 | 41 | 42 | 271 |
Post Discharge Visit 2 | 108 | 24 | 24 | 156 |
Post Discharge Visit 3 | 36 | 10 | 10 | 56 |
04/03/2024
| Plasma | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Post Discharge Visit 1 | 43 | 1.03 |
Post Discharge Visit 2 | 24 | 1.13 |
Post Discharge Visit 3 | 10 | 1.13 |
| Whole Blood, DNA Extraction | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Post Discharge Visit 1 | 41 | 1.96 |
Post Discharge Visit 2 | 24 | 1.96 |
Post Discharge Visit 3 | 10 | 1.93 |
| Whole Blood, RNA Extraction | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Post Discharge Visit 1 | 42 | 7.99 |
Post Discharge Visit 2 | 24 | 7.81 |
Post Discharge Visit 3 | 10 | 8.00 |
Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.
Resources Available
Specimens and Study DatasetsMaterials Available
- Plasma
- Whole Blood
- More Details
Study Documents
- Data Dictionary (PDF - 892.3 KB)
- FIRE CORAL Case Report Forms (PDF - 793.4 KB)
- FIRE CORAL Manual of Operating Procedures (PDF - 658.3 KB)
- FIRE CORAL Protocol (PDF - 632.1 KB)
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