Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study (BLUE CORAL) - Catalog

Name

Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study (BLUE CORAL)

Accession Number

HLB02732323a

Acronym

PETAL-BLUE CORAL

Related studies

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

PBC

Is public use dataset

False

Keywords

COVID-19

SARS-CoV-2

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)

2023-07-05

Study Open Date (Specimens)

2023-12-05

Date materials available

2023-07-05

Last updated

None

Study period

June 2020 to March 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

71

Conditions

Corona Virus Infection
SARS-CoV Infection

Objectives

To measure the incidence and changes over time in symptoms, disability, and financial status after COVID-19–related hospitalization.

Background

For many individuals, the effects of COVID-19 persist after the acute phase and result in prolonged symptoms and disability. This has led to widespread efforts to characterize the epidemiologic characteristics of such post-COVID-19 sequelae. However, accurate data were limited, hindering the ability to counsel patients, caregivers, and policy makers and to plan relevant recovery-focused clinical research. Thus, 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.

Participants

Participants included English- or Spanish-speaking adults that were hospitalized at one of the 44 PETAL Network hospitals across the U.S. within 14 days of a positive molecular test for SARS-CoV-2 with fever and/or respiratory signs or symptoms compatible with COVID-19. Patients were enrolled within the first 72 hours of hospital admission and were excluded if they had opted for comfort care, were incarcerated, or had severe prehospitalization disabilities or cognitive impairment.


A total of 1388 COVID-19 patents were enrolled, with 825 (444 male, and 379 female) that completed at least one follow-up survey.


A subset of the BLUE CORAL adult participants were enrolled in the extension study, FIRE CORAL. FIRE CORAL was a multicenter prospective cohort study of participants recovering from COVID-19 disease after discharge from the hospital.

Design

BLUE CORAL was a prospective cohort study. Participants were enrolled between August 24, 2020, and July 20, 2021, with follow-up occurring through March 30, 2022. Posthospital surveys were administered by trained interviewers in English or Spanish to patients or their proxies at 1, 3, and 6 months after enrollment. Cardiopulmonary symptoms were assessed using the Airways Questionnaire 20, the Kansas City Cardiomyopathy Questionnaire, and the Seattle Angina Questionnaire. Fatigue was assessed using the Patient Health Questionnaire-9. Disability was assessed by self-report of limitations in activities of daily living (ADLs) or instrumental activities of daily living (IADLs). Financial problems were assessed using the World Health Organization Disability Assessment Schedule 2.0 question and questions regarding job changes, time off work, and insurance coverage developed with the Mi-COVID-19 study using qualitative interviews. Quality of life was measured using the European Quality of Life 5-dimension 5-level instrument.


The primary outcomes were new or worsened cardiopulmonary symptoms, financial problems, functional impairments, perceived return to baseline health, and quality of life. Symptoms that were not present before hospitalization or specifically reported as increased in severity were counted as new or worsened.

Conclusions

The findings of this cohort study of people discharged after COVID-19 hospitalization suggest that recovery in symptoms, functional status, and fatigue was limited at 6 months, and some participants reported new problems 6 months after hospital discharge.


Admon AJ, Iwashyna TJ, Kamphuis LA, Gundel SJ, Sahetya SK, Peltan ID, Chang SY, Han JH, Vranas KC, Mayer KP, Hope AA, Jolley SE, Caldwell E, Monahan ML, Hauschildt K, Brown SM, Aggarwal NR, Thompson BT, Hough CL; National Heart, Lung, and Blood Institute PETAL Network. Assessment of Symptom, Disability, and Financial Trajectories in Patients Hospitalized for COVID-19 at 6 Months. JAMA Netw Open. 2023 Feb 1;6(2):e2255795. doi: 10.1001/jamanetworkopen.2022.55795. PMID: 36787143; PMCID: PMC9929698.

Disease classification

Publications

Mat types

Bronchial Lavage
Plasma
Tracheal Aspirate
Urine
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

    1,375 Subjects


    Last Modified: March 18, 2024, 10:27 a.m.
  • Age
  • Sex

     

    Total Subjects

    Male

    741

    Female

    634


    Last Modified: March 18, 2024, 10:27 a.m.
  • Race

     

    Total Subjects

    BLACK

    253

    HISPANIC

    385

    MISSING/UNKNOWN/REFUSED

    58

    OTHER

    63

    WHITE

    616


    Last Modified: March 18, 2024, 10:27 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, Urine, BAL, Sputum


    Last Modified: March 18, 2024, 10:27 a.m.
  • General Freeze/Thaw Status

    03/18/2024

    All specimens are unthawed


    Last Modified: March 18, 2024, 10:27 a.m.
  • Visits (Vials)

    03/18/2024

     

    Plasma

    Whole Blood, DNA Extraction

    Whole Blood, RNA Extraction

    Urine

    Bronchoalveolar Lavage (BAL)

    Sputum

    Total Vials

    Floor Draw

    2,123

    544

    549

    .

    .

    .

    3,216

    ICU Draw A

    873

    192

    194

    588

    175

    30

    2,052

    ICU Draw B

    634

    138

    140

    .

    .

    .

    912

    ICU Draw C

    364

    75

    78

    .

    .

    .

    517

    ICU Draw D

    279

    55

    56

    .

    .

    .

    390

    ICU Draw E

    193

    39

    41

    .

    .

    .

    273


    Last Modified: March 18, 2024, 10:30 a.m.
  • Visits (Subjects)

    03/18/2024

     

    Plasma

    Total number of subjects

    Average volume (mL) per subject

    Floor Draw

    534

    1.05

    ICU Draw A

    195

    1.19

    ICU Draw B

    137

    1.32

    ICU Draw C

    78

    1.33

    ICU Draw D

    57

    1.29

    ICU Draw E

    39

    1.43

     

     

    Urine

    Total number of subjects

    Average volume (mL) per subject

    ICU Draw A

    99

    7.83

     

     

    Bronchoalveolar Lavage (BAL)

    Total number of subjects

    Average volume (mL) per subject

    ICU Draw A

    36

    4.29

     

     

    Sputum

    Total number of subjects

    Average volume (mL) per subject

    ICU Draw A

    20

    1.18

     

     

    Whole Blood, DNA Extraction

    Total number of subjects

    Average volume (mL) per subject

    Floor Draw

    544

    2.33

    ICU Draw A

    192

    2.41

    ICU Draw B

    138

    2.49

    ICU Draw C

    75

    2.45

    ICU Draw D

    55

    2.45

    ICU Draw E

    39

    2.28

     

     

    Whole Blood, RNA Extraction

    Total number of subjects

    Average volume (mL) per subject

    Floor Draw

    549

    7.23

    ICU Draw A

    194

    7.48

    ICU Draw B

    140

    7.45

    ICU Draw C

    78

    7.53

    ICU Draw D

    56

    7.63

    ICU Draw E

    41

    7.43


    Last Modified: March 18, 2024, 10:30 a.m.