Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Functional, imaging, and respiratory evaluation in CORAL (FIRE CORAL) - Catalog

Name

Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Functional, imaging, and respiratory evaluation in CORAL (FIRE CORAL)

Accession Number

HLB02822424a

Acronym

PETAL-FIRE CORAL

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)

BSI Study IDs

PTF

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

https://petalnet.org/studies.html

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

Clinical Trial URLs
N/A
Study type

Epidemiology Study

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Study Open Date (Data)

2024-03-01

Study Open Date (Specimens)

2024-03-01

Date materials available

2024-02-15

Last updated

None

Study period

June 2021 to May 2022

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

non-HIV

COVID study classification

COVID

Pre-Website # of Specimens Shipped

None

# of Returned Specimens

None

Primary Publication URLs
N/A
Conditions

Corona Virus Infection
SARS-CoV Infection

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.

Conclusions

Disease classification

Publications

Mat types

Plasma
Whole Blood

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    50 Subjects


    Last Modified: April 3, 2024, 8:59 a.m.
  • Age
  • 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 of the BioLINCC handbook describes the components of the review process

  • 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.