COVID-19: Epidemiological Study of the Spread of SARS-CoV-2 in the Household of a Person Who Has Had a COVID-19 Disease
NCT04511949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2021-02-03
Summary
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus.
Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach.
As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people.
All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved.
If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus.
The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.
Conditions
- Coronavirus Infection
Interventions
- DIAGNOSTIC_TEST
-
COVID-19 IgG / IgM rapid test (whole blood, serum, plasma)
* The rapid test is performed using a drop of blood obtained at the fingertip (10 microliters) using a lancet. * The dropper pipette, held vertically, collects the drop of whole blood up to the "sample line" * Place 1 drop of whole blood (10 μL in the sample well (S) of the cassette. * Immediately add 2 drops (80μL) of buffer to the well (B) of the cassette. * Avoid air bubbles; if there is an air bubble, add a 3rd drop of buffer. The reading is taken after 10 minutes at most by the healthcare professional under medical supervision. In case of sepositivity of the rapid test, it may be offered to index cases and adult contacts, a blood sample of 5 ml of blood for a serothèque allowing a characterization of the antibodies and in particular of the neutralizing antibodies.
Sponsors & Collaborators
-
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-12
- Primary Completion
- 2020-09-30
- Completion
- 2020-11-30
Countries
- France
Study Locations
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