## Protocol Section
### Identification Module
**NCT ID:** NCT04322279

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

**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)

#### Organization Study ID Info
**ID:** C20-16
#### Organization
**Class:** OTHER_GOV
**Full Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### Secondary ID Infos
**Domain:** RCB-ID
**ID:** 2020-A00609-30
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-30

**Overall Status:** SUSPENDED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-09

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2020-03-26
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-24
**Study First Submit QC Date:** 2020-03-24
**Why Stopped:** no topics to include
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Institut National de la Santé Et de la Recherche Médicale, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Coronavirus

**Keywords:**

- contact subject

- high/moderate risk of transmission

### Design Module

#### Bio Spec

**Description:** Blood samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** SARS-CoV-2 serology

**Name:** Serology

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Description:** Whole exome sequencing

**Name:** Sequencing

**Type:** GENETIC

### Outcomes Module

#### Primary Outcomes

**Description:** Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

**Measure:** 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)

#### Secondary Outcomes

**Description:** Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

**Measure:** Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);

**Time Frame:** 30 days (+/-7)

**Description:** ELISA, microneutralisation assay

**Measure:** Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

**Time Frame:** 365 days (+/-30)

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Besançon

**Country:** France

**Facility:** Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

**Zip:** 25030

**Location 2:**

**City:** Bordeaux

**Country:** France

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

**Zip:** 33076

**Location 3:**

**City:** Clermont Ferrand

**Country:** France

**Facility:** Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

**Zip:** 63000

**Location 4:**

**City:** Dijon

**Country:** France

**Facility:** Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

**Zip:** 21 079

**Location 5:**

**City:** Grenoble

**Country:** France

**Facility:** Centre d'investigation clinique 1406 CHU Grenoble

**Zip:** 38043

**Location 6:**

**City:** Lille

**Country:** France

**Facility:** Centre d'Investigation Clinique 1403 -CHU Lille

**Zip:** 59037

**Location 7:**

**City:** Paris

**Country:** France

**Facility:** Centre d'Investigation Clinique Hôpital Saint Louis

**Zip:** 75010

**Location 8:**

**City:** Paris

**Country:** France

**Facility:** Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

**Zip:** 75018

**Location 9:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Cochin CIC 1417 Bâtiment Lavoisier

**Zip:** 75679

**Location 10:**

**City:** Rennes

**Country:** France

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

**Zip:** 35033

**Location 11:**

**City:** Saint Denis

**Country:** France

**Facility:** Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

**Zip:** 97400

**Location 12:**

**City:** Saint Etienne

**Country:** France

**Facility:** Département maladie infectieux CHU Saint Etienne

**Zip:** 42055

**Location 13:**

**City:** Saint-Pierre

**Country:** France

**Facility:** Centre d'Investigation Clinique Ile de la Réunion CHU sud

**Zip:** 97448

**Location 14:**

**City:** Tours

**Country:** France

**Facility:** Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

**Zip:** 37000

**Location 15:**

**City:** Vandœuvre-lès-Nancy

**Country:** France

**Facility:** Centre Investigation Clinique 1433 CHRU de NANCY

**Zip:** 54511

**Location 16:**

**City:** Cayenne

**Country:** French Guiana

**Facility:** Service de Maladies infectieuses et tropicales Centre hospitalier

**Zip:** 97306

#### Overall Officials

**Official 1:**

**Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France

**Name:** Xavier DUVAL, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: SARS-CoV-2 Infection

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: HIGH

- As Found: Coronavirus

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-24
