CORE Study COVID-19
Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2020
CompletedFirst Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedAugust 28, 2020
August 1, 2020
7 months
August 26, 2020
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients with confirmed or suspected of coronavirus infe
Clinical and laboratory data will be collected throughout the acute illness period. Research data will be integrated with information available from hospital and regulatory files.
Eligibility Criteria
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)
You may qualify if:
- Suspected or proven Coronavirus infection (COVID-19)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, 22281100, Brazil
Related 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. No abstract available.
PMID: 24355025BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Bozza, phD
D'Or Institute for Research and Education (IDOR)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 14 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 28, 2020
Study Start
March 2, 2020
Primary Completion
September 30, 2020
Study Completion
September 30, 2021
Last Updated
August 28, 2020
Record last verified: 2020-08