Clinical trial NCT04531202: CORE Study COVID-19
Official title: Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection (COVID-19)
Keywords: coronavirus
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronavirus infection and molecular laboratory diagnosis of COVID-19, made from material collected from the upper respiratory tract (nasopharynx or oropharynx) or from the lower respiratory tract (sputum, tracheal aspirate or bronchoalveolar lavage)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical characterization of coronavirus disease-2019 (COVID-19)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'Or Institute for Research and Education (IDOR)
Study officials:
affiliation: D'Or Institute for Research and Education (IDOR)
name: Fernando Bozza, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.