Coronavirus Infection (COVID-19) Clinical Trial
Official title:
Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04278404 -
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
|