Clinical trial NCT04259892: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.
Official title: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Keywords: contact subject
high/moderate risk of transmission
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-02-07
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

This include both children and adult subjects, and healthcare workers. It may also include subject without social security in some countries, according to local legislation.

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.

Detailed description: Procedures added by the research:

Phone calls for collection of reported symptoms. Nasopharyngeal swabs for determination of the presence of SARS-CoV-2 detected by PCR.

Blood sampling for determination of the presence of SARS-CoV-2 IgM or IgG. Saliva or blood sampling for whole exome sequencing of the subject.

Eligibility criteria: Inclusion Criteria:

1. High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
2. Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
3. Obtaining informed consent.

Exclusion Criteria:

* Subject deprived of freedom
* Subject under a legal protective measure

Primary outcomes:
measure: Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
timeFrame: 12 days (+/-2)
Secondary outcomes:
measure: Time to apparition of any symptom suggestive of SARS-CoV-2 from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
timeFrame: 12 days (+/-2)
measure: Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion
timeFrame: 12 days (+/-2)
measure: Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection
timeFrame: 12 days (+/-2)
measure: Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection
timeFrame: 12 days (+/-2)
measure: Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact
timeFrame: 30 days (+/-7)
measure: Host genetic variants
timeFrame: 1 day
measure: The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.
timeFrame: 365 days (+/-30)
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon
city: Bordeaux
country: France
facility: Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin
city: Clermont-Ferrand
country: France
facility: Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand
city: Dijon
country: France
facility: Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne
city: Grenoble
country: France
facility: Centre d'investigation clinique 1406 CHU Grenoble
city: Lille
country: France
facility: Centre d'Investigation Clinique 1403 -CHU Lille
city: Nancy
country: France
facility: Centre Investigation Clinique 1433 CHRU de NANCY
city: Paris
country: France
facility: Centre d'Investigation Clinique Hôpital Saint Louis
city: Paris
country: France
facility: Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier
city: Rennes
country: France
facility: Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou
city: Saint Denis
country: France
facility: Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord
city: Saint-Pierre
country: France
facility: Centre d'Investigation Clinique Ile de la Réunion CHU sud
city: Saint-Étienne
country: France
facility: Département maladie infectieux CHU Saint Etienne
city: Tours
country: France
facility: Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau
city: Cayenne
country: French Guiana
facility: Service de Maladies infectieuses et tropicales Centre hospitalier
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Xavier Duval, MD
role: PRINCIPAL_INVESTIGATOR
References: