Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronavirus
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Enrollment
- 81
- Locations
- 16
- Primary Endpoint
- Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.
Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.
Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.
Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.
The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.
This include both children and adult subjects, subject without social security, and healthcare workers.
Detailed Description
Procedures added by the research: Blood sampling for determination of the presence of SARS-CoV-2 type M immunoglobulins or type G immunoglobulins. Blood sampling for whole exome sequencing
Investigators
Eligibility Criteria
Inclusion Criteria
- •High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
- •Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
- •Obtaining informed consent.
Exclusion Criteria
- •Subject included in the CoV-CONTACT study
- •Subject deprived of freedom
- •Subject under a legal protective measure
Outcomes
Primary Outcomes
Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
Time Frame: 30 days (+/-7)
Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
Secondary Outcomes
- Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);(30 days (+/-7))
- Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.(365 days (+/-30))