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

Completed

• Conditions: Coronavirus

• Registration Number: NCT04259892
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2020-02-04
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	12 days (+/-2)	PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Secondary Outcome Measures

Name	Time	Method
Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion	12 days (+/-2)	nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
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)	ELISA, microneutralisation essay
The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.	365 days (+/-30)	ELISA, microneutralisation essay
Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection	12 days (+/-2)	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, ...)
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)	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, ...)
Host genetic variants	1 day	Whole exome sequencing
Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection	12 days (+/-2)	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, ...)

Trial Locations

Locations (16)

Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Investigation Clinique 1433 CHRU de NANCY; 🇫🇷 Nancy, France

Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon; 🇫🇷 Besançon, France

Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne; 🇫🇷 Dijon, France

Département maladie infectieux CHU Saint Etienne; 🇫🇷 Saint-Étienne, France

Service de Maladies infectieuses et tropicales Centre hospitalier; 🇬🇫 Cayenne, French Guiana

Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin; 🇫🇷 Bordeaux, 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

Centre d'Investigation Clinique Ile de la Réunion CHU sud; 🇫🇷 Saint-Pierre, France

Centre d'investigation clinique 1406 CHU Grenoble; 🇫🇷 Grenoble, France

Centre d'Investigation Clinique 1403 -CHU Lille; 🇫🇷 Lille, France

Centre d'Investigation Clinique Hôpital Saint Louis; 🇫🇷 Paris, France

Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France

Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier; 🇫🇷 Paris, France

Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France