NCT04531202|UnknownDMC
CORE Study COVID-19
Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
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Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
Sponsor study identifier
observational
2,000
1 country
1
Study Start
March 2, 2020
Actual (reported)Primary Completion
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2020
Actual (reported)August 26, 2020
Actual (reported)August 28, 2020
Actual (reported)September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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)
D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, 22281100, Brazil
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.
Fernando Bozza, phD
D'Or Institute for Research and Education (IDOR)
First Submitted
August 26, 2020
First Posted
August 28, 2020
Study Start
March 2, 2020
Actual (reported)Primary Completion
September 30, 2020
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 28, 2020
Record last verified: 2020-08
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