Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
ERap-COV
1 other identifier
interventional
1,210
0 countries
N/A
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 antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity, specificity, predictive values)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
May 19, 2020
CompletedStudy Start
First participant enrolled
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2021
CompletedMay 28, 2020
May 1, 2020
10 months
May 19, 2020
May 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performance of several diagnostic tests : tests based either on detection of the virus SARS-CoV-2 or detection of human antibodies generated in response to infection
* Tests based on detection of the virus SARS-CoV-2 (antigenic rapid tests, molecular tests, proteomic tests): sensibility and specificity compared to RT-PCR (Ct) in salivary samples and nasopharyngeal swabs from patients and cargivers included in the study * Tests based on detection of human antibodies generated in response to infection (rapid immunodiagnostic tests, ELISA): sensibility and specificity compared to RT-PCR (Ct) and ELISA (antibody titer) in blood or serum from patients and cargivers included in the study
Total duration of the study is 10 months
Secondary Outcomes (5)
Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated
Total duration of the study is 10 months
Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence
Caregivers will be included in the study for 9 months. After inclusion (Day 0), follow-up visits at Day 15, 1 Month, 3 Months, 6 Months, 9 Months will be done.
Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms
Total duration of the study is 10 months
Sensitivity and specificity of antigenic rapid tests, molecular tests, proteomic tests according to the sample used (salivary samples or nasopharyngeal swabs) and according to the duration of the symptoms
Total duration of the study is 10 months
Suitability of rapid tests in view of its intended purpose for self-testing
4 months
Study Arms (3)
Population 1 : Patients
EXPERIMENTALHospitalized patients, positive or suspected of SARS-CoV-2 infection
Population 2 : Hospital caregivers exposed to SARS-CoV-2
EXPERIMENTALLongitudinal study of a hospital caregiver cohort
Population 3 : Lay users
EXPERIMENTALSuitability of rapid test in view of its intended purpose for self-testing
Interventions
After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank. For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.
Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 28, 2020
Study Start
May 25, 2020
Primary Completion
March 25, 2021
Study Completion
March 25, 2021
Last Updated
May 28, 2020
Record last verified: 2020-05