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 | Completed DMC

• 1 other identifier: CREPATS 012
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measure of the proportion of contact persons who have developed anti-SARS-CoV-2 antibodies (secondary transmission rate) within the same household of a subject who had a COVID-19 disease assessed by a rapid diagnostic-oriented test

  Measure of anti-SARS-CoV-2 antibodies using COVID-PRESTO (AAZ company)

  4 hours

Study Arms (1)

No arm

OTHER

No arm

Diagnostic Test: COVID-19 IgG / IgM rapid test (whole blood, serum, plasma)

Interventions

COVID-19 IgG / IgM rapid test (whole blood, serum, plasma) DIAGNOSTIC_TEST

* 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.

No arm

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Index case
• Adult\> 18 years old
• Having presented a SARS-CoV-2 infection confirmed by PCR (INDEX COVID / PCR +)
• or having presented clinical symptoms compatible with the diagnosis of COVID-19 (COVID-like) with at least 3 of the following symptoms for ⩾ 48 hours: fever, cough, anosmia, ageusia, headache, diarrhea, or CT scan with pneumopathy image in frosted glass
• Living at the time of symptoms with at least 2 other people in the same household
• Written consent for himself and for minors for whom he is responsible
• Contact case
• Adult (s) or child (ren), aged 3 to 17 (school age including kindergarten), living in the same household as the index case at the time of the symptoms of the index case
• Written consent for adults
• Consent given by parents for minors

You may not qualify if:

• Patient protected by law (patient under guardianship and guardianship, person deprived of liberty)
• Patient with major cognitive disorders.

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Christine KATLAMA

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cross-sectional, single-center study carried out on the cohort of index patients followed on an outpatient basis

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 13, 2020
• Study Start: July 12, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

FR (1)