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

NCT04322279 | Terminated

• 2 other identifiers: C20-162020-A00609-30
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus

Keywords

contact subject; high/moderate risk of transmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Interventions

Serology DIAGNOSTIC_TEST

SARS-CoV-2 serology

Sequencing GENETIC

Whole exome sequencing

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Subject included in the CoV-CONTACT study
• Subject deprived of freedom
• Subject under a legal protective measure

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (16)

Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

Besançon, 25030, France

Location

Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin

Bordeaux, 33076, France

Location

Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

Dijon, 21 079, France

Location

Centre d'investigation clinique 1406 CHU Grenoble

Grenoble, 38043, France

Location

Centre d'Investigation Clinique 1403 -CHU Lille

Lille, 59037, France

Location

Centre d'Investigation Clinique Hôpital Saint Louis

Paris, 75010, France

Location

Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Hôpital Cochin CIC 1417 Bâtiment Lavoisier

Paris, 75679, France

Location

Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

Saint-Denis, 97400, France

Location

Département maladie infectieux CHU Saint Etienne

Saint-Etienne, 42055, France

Location

Centre d'Investigation Clinique Ile de la Réunion CHU sud

Saint-Pierre, 97448, France

Location

Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

Tours, 37000, France

Location

Centre Investigation Clinique 1433 CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Service de Maladies infectieuses et tropicales Centre hospitalier

Cayenne, 97306, French Guiana

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Xavier DUVAL, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: March 9, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

FR (1)