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

Coronavirus Clinical Trial

— Cov-CONTACT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04259892
• Other study ID #: C20-06
• Secondary ID: 2020-A00280-39
• Status: Suspended
• Start date: February 4, 2020
• Est. completion date: December 4, 2022

Study information

• Verified date: July 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 345
• Est. completion date: December 4, 2022
• Est. primary completion date: December 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19

Intervention

Biological:
• 2019-nCoV PCR
Nasopharyngeal swabs

Locations

Country	Name	City	State
France	Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon	Besançon
France	Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin	Bordeaux
France	Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand	Clermont-Ferrand
France	Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne	Dijon
France	Centre d'investigation clinique 1406 CHU Grenoble	Grenoble
France	Centre d'Investigation Clinique 1403 -CHU Lille	Lille
France	Centre Investigation Clinique 1433 CHRU de NANCY	Nancy
France	Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard	Paris
France	Centre d'Investigation Clinique Hôpital Saint Louis	Paris
France	Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier	Paris
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	Département maladie infectieux CHU Saint Etienne	Saint-Étienne
France	Centre d'Investigation Clinique Ile de la Réunion CHU sud	Saint-Pierre
France	Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau	Tours
French Guiana	Service de Maladies infectieuses et tropicales Centre hospitalier	Cayenne

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  French Guiana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Host genetic variants	Whole exome sequencing	1 day
Secondary	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)