COVID-19 Clinical Trial
— ERap-COVOfficial title:
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
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)
Status | Not yet recruiting |
Enrollment | 1210 |
Est. completion date | March 25, 2021 |
Est. primary completion date | March 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated | Hospitalized patients, positive or suspected of SARS-CoV-2 infection are included in the study. Medical data related to COVID-19 infection will be recorded. Caregivers will be asked information about their health status related to a possible COVID-19 infection: symptoms if any, symptoms duration, severity. |
Total duration of the study is 10 months | |
Secondary | Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence | At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit. | 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. | |
Secondary | Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms | Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded. | Total duration of the study is 10 months | |
Secondary | 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 | Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded. | Total duration of the study is 10 months | |
Secondary | Suitability of rapid tests in view of its intended purpose for self-testing | 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. | 4 months |
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