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)

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.

Study Overview

• Status: Terminated
• Conditions: Coronavirus
• Intervention / Treatment: Diagnostic test: Serology; Genetic: Sequencing

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

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon
  • Bordeaux, France, 33076
    • Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin
  • Clermont Ferrand, France, 63000
    • Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand
  • Dijon, France, 21 079
    • Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne
  • Grenoble, France, 38043
    • Centre d'investigation clinique 1406 CHU Grenoble
  • Lille, France, 59037
    • Centre d'Investigation Clinique 1403 -CHU Lille
  • Paris, France, 75010
    • Centre d'Investigation Clinique Hôpital Saint Louis
  • Paris, France, 75018
    • Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard
  • Paris, France, 75679
    • Hôpital Cochin CIC 1417 Bâtiment Lavoisier
  • Rennes, France, 35033
    • Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou
  • Saint Denis, France, 97400
    • Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord
  • Saint Etienne, France, 42055
    • Département maladie infectieux CHU Saint Etienne
  • Saint-Pierre, France, 97448
    • Centre d'Investigation Clinique Ile de la Réunion CHU sud
  • Tours, France, 37000
    • Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Investigation Clinique 1433 CHRU de NANCY
• French Guiana
  • Cayenne, French Guiana, 97306
    • Service de Maladies infectieuses et tropicales Centre hospitalier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);	Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay	30 days (+/-7)
Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.	ELISA, microneutralisation assay	365 days (+/-30)

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Xavier Duval, MD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: contact subject; high/moderate risk of transmission
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections
• Other Study ID Numbers: C20-16; 2020-A00609-30 (Registry Identifier: RCB-ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No