Skip to content

Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.

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)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04322279
Enrollment
81
Registered
2020-03-26
Start date
2020-03-09
Completion date
2022-12-31
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus

Keywords

contact subject, high/moderate risk of transmission

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

Interventions

DIAGNOSTIC_TESTSerology

SARS-CoV-2 serology

GENETICSequencing

Whole exome sequencing

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.30 days (+/-7)Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

Secondary

MeasureTime frameDescription
Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);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.365 days (+/-30)ELISA, microneutralisation assay

Countries

France, French Guiana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026