Prevention and Early Treatment of Acute Lung Injury (PETAL) Network - Repository of Electronic Data COVID-19 Observational Study (RED CORAL)

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Accession Number
HLB02542121a

Study Type
Epidemiology Study

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

Study Period
March 2020 – June 2020

NHLBI Division
DLD

Dataset(s) Last Updated
November 29, 2021

Clinical Trial URLs
N/A

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Objectives

The objective of PETAL-RED CORAL was to collect data for investigation of demographics, clinical characteristics, risk factors, care practices, outcomes and resource utilization of patients hospitalized with severe acute COVID-19.

Background

Shortly after the identification of the novel pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), the World Health Organization declared COVID-19 a public health emergency of international concern. When this study began, the epidemiology of patients hospitalized with severe COVID-19 had not been well defined, especially in the American context. There were significant knowledge gaps regarding demographics, clinical characteristics, trajectory of disease, timing of recovery, predictors of organ failure and death, resource utilization, and post-hospital outcomes. Furthermore, there existed limited understanding of biologic pathways activated by this viral syndrome and which patients were at risk for progression to more severe illness. The purpose of the PETAL-RED CORAL study was to inform epidemiology and resource utilization through data collection and creation of a data repository.

Participants

Eligible participants were hospitalized adult patients who had a positive test for COVID-19 within 14 days of admission. Patients had evidence of acute COVID-19 as characterized by signs and symptoms such as fever, cough, dyspnea, hypoxemia, and infiltrates on chest imaging. PETAL-RED CORAL includes patients who presented for admission to study hospitals between March 1st, 2020 and April 1st, 2020.

Design

RED CORAL was a multicenter, observational medical record review study of patients with COVID-19 admitted to PETAL Network hospitals. Data collected includes demographics, comorbidities, clinical parameters, patient management, mortality, and functional outcomes.

Eligible patients cared for on the acute care ward underwent “focused” data collection. Eligible patients cared for in the ICU at any point of their hospital stay were eligible for “detailed” data collection. After the first 25 ICU patients across a center’s sites had been identified for detailed data collected, all following patients could be assigned to either detailed or focused data collection.

Focused collection consists of baseline data (day of presentation); daily assessments on days 1, 4, 8, 15, 21, 28, as well as ICU day 1 if applicable and not overlapping with the other listed days; and discharge data (up to study day 60). Detailed data collection consists of baseline data (day of presentation); daily assessments on hospital days 1-15, day 21 and 28, ICU days 1-15 if they do not overlap with other listed days, and discharge data (up to study day 60).

Key outcomes included respiratory failure, shock, cardiac complications, prolonged mechanical ventilation, and death.

Conclusions

In a geographically diverse early-pandemic COVID-19 cohort with complete hospital follow-up, hospital mortality was associated with older age, comorbidity burden, and male sex. Intensive care unit admissions occurred early and were associated with protracted hospital stays. Survivors often required new health care services or respiratory support at discharge.

Peltan ID, Caldwell E, Admon AJ, Attia EF, Gundel SJ, Mathews KS, Nagrebetsky A, Sahetya SK, Ulysse C, Brown SM, Chang SY, Goodwin AJ, Hope AA, Iwashyna TJ, Johnson NJ, Lanspa MJ, Richardson LD, Vranas KC, Angus DC, Baron RM, Haaland BA, Hayden DL, Thompson BT, Rice TW, Hough CL. Characteristics and Outcomes of US Patients Hospitalized With COVID-19. Am J Crit Care. 2021 Oct 28:e1-e12. doi: 10.4037/ajcc2022549. Epub ahead of print. PMID: 34709373.

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Resources Available

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Study Documents

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