- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531202
CORE Study COVID-19
Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Rio de Janeiro, Brazil, 22281100
- Recruiting
- D'Or Institute for Research and Education (IDOR)
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Contact:
- Fernando Bozza, phD
- Phone Number: 5521993031551
- Email: bozza.fernando@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical characterization of coronavirus disease-2019 (COVID-19)
Time Frame: 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. |
1 year
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29496920.8.0000.5262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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