Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.

Study Overview
=================
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.

Official Title
-----------------
Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

Conditions
-----------------
Coronavirus

Intervention / Treatment
-----------------
* Biological: 2019-nCoV PCR


Participation Criteria
=================
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 deprived of freedom Subject under a legal protective measure
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 2019-nCoV PCR|Nasopharyngeal swabs|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact | 12 days (+/-2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...) | 12 days (+/-2) | 
| Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion | nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact | 12 days (+/-2) | 
| Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection | Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...) | 12 days (+/-2) | 
| Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection | Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...) | 12 days (+/-2) | 
| 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 | ELISA, microneutralisation essay | 30 days (+/-7) | 
| Host genetic variants | Whole exome sequencing | 1 day | 
| The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. | ELISA, microneutralisation essay | 365 days (+/-30) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact subject, high/moderate risk of transmission