Status:
UNKNOWN
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
SARS-CoV 2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests based on anti...
Detailed Description
Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health systems especia...
Eligibility Criteria
Inclusion
- Common criteria for the 3 populations :
- Persons over 18 years of age
- Beneficiary or person entitled to a social security scheme
- Population 1 (Patients) :
- Patients presenting for hospital admission on suspicion of SARS-Cov-2 infection based on the WHO definition and local guidelines
- Patient or relative/trusted person who has been informed about the study and has given informed consent.
- Population 2 (Caregivers) :
- Caregivers exposed to COVID-19 in the course of their duties in the clinical departments of the Bicêtre and Paul Brousse hospitals.
- Caregiver who gave informed consent.
- Population 3 (Lay Users) :
- Clients presenting themselves in one of the volunteer dispensary pharmacies located in the Île-de-France region, who will be called "lay users".
- Presentation on a study site
- Exclusion Criteria:
- Common criteria for the 3 populations:
- \- Person subject to a justice protection measure
- Population 1 (Patients):
- Refusal to participate by the patient / support person or close friend
- Patient not speaking French and not accompanied by a translator
- Patient under guardianship or curatorship
- Person under AME (State medical aid)
- Population 2 (Caregivers):
- \- Refusal to participate
- Population 3 (lay users):
- Refusal to participate
- Person not speaking French and not accompanied by a translator
- Person under AME (State medical aid)
- Person out of state to consent, under guardianship or curatorship
- Pregnant and lactating women
Exclusion
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2021
Estimated Enrollment :
1210 Patients enrolled
Trial Details
Trial ID
NCT04405492
Start Date
May 25 2020
End Date
March 25 2021
Last Update
May 28 2020
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