Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID19.

Coronavirus Clinical Trial

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04322279
• Other study ID #: C20-16
• Secondary ID: 2020-A00609-30
• Status: Suspended
• Start date: March 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19

Intervention

Diagnostic Test:
• Serology
SARS-CoV-2 serology

Genetic:
• Sequencing
Whole exome sequencing

Locations

Country	Name	City	State
France	Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon	Besançon
France	Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin	Bordeaux
France	Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand	Clermont Ferrand
France	Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne	Dijon
France	Centre d'investigation clinique 1406 CHU Grenoble	Grenoble
France	Centre d'Investigation Clinique 1403 -CHU Lille	Lille
France	Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard	Paris
France	Centre d'Investigation Clinique Hôpital Saint Louis	Paris
France	Hôpital Cochin CIC 1417 Bâtiment Lavoisier	Paris
France	Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou	Rennes
France	Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord	Saint Denis
France	Département maladie infectieux CHU Saint Etienne	Saint Etienne
France	Centre d'Investigation Clinique Ile de la Réunion CHU sud	Saint-Pierre
France	Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau	Tours
France	Centre Investigation Clinique 1433 CHRU de NANCY	Vandœuvre-lès-Nancy
French Guiana	Service de Maladies infectieuses et tropicales Centre hospitalier	Cayenne

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  French Guiana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.	ELISA, microneutralisation assay	365 days (+/-30)