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

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

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.

Study Overview

• Status: Suspended
• Conditions: Coronavirus
• Intervention / Treatment: Biological: 2019-nCoV PCR

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 Type: Observational
• Enrollment (Anticipated): 345

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon
  • Bordeaux, France, 33076
    • Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin
  • Clermont-Ferrand, France, 63000
    • Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand
  • Dijon, France, 21 079
    • Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne
  • Grenoble, France, 38043
    • Centre d'investigation clinique 1406 CHU Grenoble
  • Lille, France, 59037
    • Centre d'Investigation Clinique 1403 -CHU Lille
  • Nancy, France, 54511
    • Centre Investigation Clinique 1433 CHRU de NANCY
  • Paris, France, 75010
    • Centre d'Investigation Clinique Hôpital Saint Louis
  • Paris, France, 75018
    • Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard
  • Paris, France, 75679
    • Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier
  • Rennes, France, 35033
    • Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou
  • Saint Denis, France, 97400
    • Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord
  • Saint-Pierre, France, 97448
    • Centre d'Investigation Clinique Ile de la Réunion CHU sud
  • Saint-Étienne, France, 42055
    • Département maladie infectieux CHU Saint Etienne
  • Tours, France, 37000
    • Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau
• French Guiana
  • Cayenne, French Guiana, 97306
    • Service de Maladies infectieuses et tropicales Centre hospitalier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

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)

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Xavier Duval, MD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): December 4, 2021
• Study Completion (Anticipated): December 4, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: contact subject; high/moderate risk of transmission
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: C20-06; 2020-A00280-39 (Registry Identifier: RCB ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No