Clinical trial NCT04405492: Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
Official title: Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV 2
COVID-19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

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 especially intensive care unit (ICU) capacities thus resulting in high mortality. On 16 March 2020, WHO Director-General called on all countries to ramp up their testing programs as the best way to slow the advance of the coronavirus pandemic. Although the current gold standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices. Before these tests can be recommended, they must be validated in the appropriate populations and settings.

Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study which aims to assess clinical performances of serological and antigenic assays for the diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG Biotech), which has shown excellent biological performance, compatible with the recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity\> 90% and specificity\> 98%, 15 days after symptoms) (1). Finally, AID funding will be used to develop 100% French-made serological and antigenic RDTs in less than a year.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Total duration of the study is 10 months
Secondary outcomes:
measure: Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated
timeFrame: Total duration of the study is 10 months
measure: Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence
timeFrame: 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.
measure: Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms
timeFrame: Total duration of the study is 10 months
measure: 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
timeFrame: Total duration of the study is 10 months
measure: Suitability of rapid tests in view of its intended purpose for self-testing
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References: