Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design

Iván J. Núñez-Gil, Vicente Estrada, Cristina Fernández-Pérez, Gisela Feltes, Oscar Vedia, Carlos E. Vergara-Uzcategui, Víctor H. Moreno-Menguía, Enrico Cerrato, Fabrizio D'Ascenzo, Sergio Raposeiras-Roubin, F. Javier Martín-Sánchez, Emilio Alfonso-Rodríguez, Jia Huang, Harish Ramakrishna, Emma Gil-Higes, Antonio Fernández-Ortiz, Carlos Macaya

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

The disease produced by the new coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), named COVID-19 (Coronavirus Disease-2019) has recently been classified as a pandemic by the World Health Organization (WHO). However, scarce clinical data is available and generally limited to the Chinese population due to the first cases were identified in Wuhan (Hubei, China). This article describes the rationale and design of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) registry (ClinicalTrials.gov Identifier: NCT04334291). With an ambispective cohort design, eligible patients are those discharged, deceased or alive, from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion. With a current recruitment of more than 7000 cases, in 46 hospitals in 8 countries, since it is not possible to estimate the sample size based on literature reports, the investigators will try to get the maximum numbers of patients possible. The study primary objective is all cause mortality and aims to characterize the clinical profile of patients infected in order to develop a prognostic clinical score allowing, rapid logistic decision making. As secondary objectives, the analysis of other clinical events, the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed. The results of HOPE COVID-19 will contribute to a better understanding of this condition. We aim to describe the management of this condition as well as the outcomes in relation to the therapy chosen, in order to gain insight into improving patient care in the coming months. Clinical Trial registration: ClinicalTrials.gov. Unique identifier: NCT04334291.

Original languageEnglish (US)
Article number100654
JournalContemporary Clinical Trials Communications
Volume20
DOIs
StatePublished - Dec 2020

Keywords

  • COVID-19
  • Mortality
  • Prognosis
  • Registry
  • Score

ASJC Scopus subject areas

  • Pharmacology

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