Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronavirus
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Enrollment
- 324
- Locations
- 16
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- last year
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Time Frame: 12 days (+/-2)
PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
Secondary Outcomes
- Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion(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(30 days (+/-7))
- The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.(365 days (+/-30))
- Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection(12 days (+/-2))
- 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.(12 days (+/-2))
- Host genetic variants(1 day)
- Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection(12 days (+/-2))