CORE Study COVID-19

Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04531202

Enrollment

2000

Registered

2020-08-28

Start date

2020-03-02

Completion date

2021-09-30

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection (COVID-19)

Keywords

coronavirus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Contacts

Primary ContactFernando Bozza, phD

bozza.fernando@gmail.com55 21 993031551

Outcome results