Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19 (ERap-COV)
Primary Purpose
SARS-CoV 2, COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
Capillary and salivary sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for SARS-CoV 2
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Population 1 : Patients
Population 2 : Hospital caregivers exposed to SARS-CoV-2
Population 3 : Lay users
Arm Description
Hospitalized patients, positive or suspected of SARS-CoV-2 infection
Longitudinal study of a hospital caregiver cohort
Suitability of rapid test in view of its intended purpose for self-testing
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04405492
First Posted
May 19, 2020
Last Updated
May 25, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04405492
Brief Title
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
Acronym
ERap-COV
Official Title
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Anticipated)
Primary Completion Date
March 25, 2021 (Anticipated)
Study Completion Date
March 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Population 1 : Patients
Arm Type
Experimental
Arm Description
Hospitalized patients, positive or suspected of SARS-CoV-2 infection
Arm Title
Population 2 : Hospital caregivers exposed to SARS-CoV-2
Arm Type
Experimental
Arm Description
Longitudinal study of a hospital caregiver cohort
Arm Title
Population 3 : Lay users
Arm Type
Experimental
Arm Description
Suitability of rapid test in view of its intended purpose for self-testing
Intervention Type
Device
Intervention Name(s)
Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
Intervention Description
After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. 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.
Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different 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.
Intervention Type
Device
Intervention Name(s)
Capillary and salivary sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Total duration of the study is 10 months
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated
Description
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.
Time Frame
Total duration of the study is 10 months
Title
Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence
Description
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.
Time Frame
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.
Title
Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms
Description
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.
Time Frame
Total duration of the study is 10 months
Title
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
Description
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.
Time Frame
Total duration of the study is 10 months
Title
Suitability of rapid tests in view of its intended purpose for self-testing
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Naas
Phone
+33145212986
Email
thierry.naas@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Marie Roque-Afonso
Phone
+33145593720
Email
anne-marie.roque@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
We'll reach out to this number within 24 hrs