CORE Study COVID-19

Coronavirus Infection (COVID-19) Clinical Trial

Official title:

Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531202
• Other study ID #: 29496920.8.0000.5262
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: D'Or Institute for Research and Education
• Contact: Fernando Bozza, phD
• Phone: 55 21 993031551
• Email: bozza.fernando[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection (COVID-19)
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education (IDOR)	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Dunning JW, Merson L, Rohde GGU, Gao Z, Semple MG, Tran D, Gordon A, Olliaro PL, Khoo SH, Bruzzone R, Horby P, Cobb JP, Longuere KS, Kellam P, Nichol A, Brett S, Everett D, Walsh TS, Hien TT, Yu H, Zambon M, Ruiz-Palacios G, Lang T, Akhvlediani T; ISARIC Working Group 3, ISARIC Council, Hayden FG, Marshall J, Webb S, Angus DC, Shindo N, van der Werf S, Openshaw PJM, Farrar J, Carson G, Baillie JK. Open source clinical science for emerging infections. Lancet Infect Dis. 2014 Jan;14(1):8-9. doi: 10.1016/S1473-3099(13)70327-X. — View Citation

Outcome

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