CORE Study COVID-19

• Conditions: Coronavirus Infection (COVID-19)

• Registration Number: NCT04531202
• Lead Sponsor: D'Or Institute for Research and Education

Brief Summary

This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.

Detailed Description

The study will be conducted at multiple sites (to be determined by the spread of disease and availability of resources). It is appreciated that settings will vary in terms of clinical infrastructure, resources and capacity. This study will enrol eligible patients (adults) with confirmed or suspected infection with a pathogen relevant to the study objectives. Recruitment of patients with Day 1 (enrolment) data and biological samples is the priority.

Observational analyses will be stratified according to available data. Outcome data for primary and secondary objectives will be derived from data from routine clinical and laboratory assessments performed as part of standard inpatient medical management at the treating site, documented using proportionate case report forms (CRF; either paper or web-based electronic 'eCRF'). Clinical and laboratory data will be collected throughout the acute illness period according to local resources. Priority at all times will be given to the collection of clinical information. Research data will be integrated as much as possible with information available from hospital and regulatory files.

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2020-08
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-27
• Last Update Submitted: 2020-08-27
• Study First Posted: 2020-08-28
• Last Update Posted: 2020-08-28
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Suspected or proven Coronavirus infection (COVID-19)

Exclusion Criteria

• Confirmed diagnosis of a pathogen unrelated to the objectives of this study (or other non-infectious diagnosis) and no indication or likelihood of co-infection with a relevant pathogen.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical characterization of coronavirus disease-2019 (COVID-19)	1 year	Describe the clinical features of the illness or syndrome and complications, and determinants of severity.; Assessment daily for 14 days, then hospital discharge.

Trial Locations

Locations (1)

D'Or Institute for Research and Education (IDOR); 🇧🇷 Rio de Janeiro, Brazil