Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Functional, imaging, and respiratory evaluation in CORAL (FIRE CORAL) - Catalog
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Name
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
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Acronym
PETAL-FIRE CORAL
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Related studies(PETAL-BLUE CORAL) Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study (BLUE CORAL)
(PETAL-RED CORAL) Prevention and Early Treatment of Acute Lung Injury (PETAL) Network - Repository of Electronic Data COVID-19 Observational Study (RED CORAL)
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BSI Study IDs
PTF
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Is public use dataset
False
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Keywords
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Ingestion StatusReleased
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Has Study Datasets
True
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Has Specimens
True
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Specimen ID TypeCoded
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Study Website
https://petalnet.org/studies.html
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The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.
False
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Clinical Trial URLsN/A
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Study typeEpidemiology Study
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Collection TypeOpen BioLINCC Study
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Cohort typeAdult
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Interventions
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Study Open Date (Data)
2024-03-01
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Study Open Date (Specimens)
2024-03-01
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Date materials available
2024-02-15
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Last updated
None
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Study period
June 2021 to May 2022
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Study Contacts
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NHLBI Division
DLD
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ClassificationLung
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HIV study classificationnon-HIV
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COVID study classificationCOVID
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Pre-Website # of Specimens Shipped
None
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# of Returned Specimens
None
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Primary Publication URLs
N/A
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsYes
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Non-genetic use specimen restrictions based on area of useYes
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Genetic use of specimens allowed?Yes, For Some Specimens
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Genetic use area of research restrictionsYes
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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.
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ConditionsCorona Virus Infection
SARS-CoV Infection
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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.
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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.
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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.
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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.
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Conclusions
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Disease classification
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Publications
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Mat typesPlasma
Whole Blood
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NetworkPrevention and Early Treatment of Acute Lung Injury (PETAL)
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
50 Subjects
Last Modified: April 3, 2024, 8:59 a.m. -
Age
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Sex
Total Subjects
Male
27
Female
23
Last Modified: April 3, 2024, 8:59 a.m. -
Race
Total Subjects
BLACK
6
HISPANIC
15
MISSING/UNKNOWN/REFUSED
4
OTHER
3
WHITE
22
Last Modified: April 3, 2024, 8:59 a.m.
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 3.0 of the BioLINCC Handbook
describes the components of the review process.
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Material Types
Plasma, Whole blood for the purpose of DNA extraction, Whole blood for the purpose of RNA extraction
Last Modified: April 3, 2024, 8:59 a.m. -
General Freeze/Thaw Status
04/03/2024
All specimens are unthawed
Last Modified: April 3, 2024, 8:59 a.m. -
Visits (Vials)
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
Last Modified: April 3, 2024, 9 a.m. -
Visits (Subjects)
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
Last Modified: April 3, 2024, 9 a.m.