Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID19.
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|ClinicalTrials.gov Identifier: NCT04322279|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : May 22, 2020
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.
|Condition or disease||Intervention/treatment|
|Coronavirus||Diagnostic Test: Serology Genetic: Sequencing|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||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)|
|Actual Study Start Date :||March 9, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
- Diagnostic Test: Serology
- Genetic: Sequencing
Whole exome sequencing
- 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
- Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7); [ Time Frame: 30 days (+/-7) ]Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
- Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. [ Time Frame: 365 days (+/-30) ]ELISA, microneutralisation assay
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322279
|Contact: Xavier DUVAL, MD||+33 1 40 25 71 email@example.com|
|Contact: Bruno LINA, MDfirstname.lastname@example.org|
|Principal Investigator:||Xavier DUVAL, MD||Institut National de la Santé Et de la Recherche Médicale, France|