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

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Accession Number
HLB02732323a

Study Type
Epidemiology Study

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
June 2020 to March 2022

NHLBI Division
DLD

Dataset(s) Last Updated
July 5, 2023

Clinical Trial URLs
N/A

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 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.

Additional Details

Subjects:

1,375 Subjects

Sex:

 

Total Subjects

Male

741

Female

634

Race:

 

Total Subjects

BLACK

253

HISPANIC

385

MISSING/UNKNOWN/REFUSED

58

OTHER

63

WHITE

616

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

General Freeze/Thaw Status:

03/18/2024

All specimens are unthawed

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

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

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Resources Available

Specimens and Study Datasets

Materials Available

  • Bronchial Lavage
  • Plasma
  • Tracheal Aspirate
  • Urine
  • Whole Blood
  • More Details

Study Documents

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