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

NCT ID: NCT04259892

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-04

Study Completion Date

2021-08-02

Brief Summary

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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

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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.

Conditions

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Coronavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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2019-nCoV PCR

Nasopharyngeal swabs

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Duval, MD

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

Besançon, , France

Site Status

Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin

Bordeaux, , France

Site Status

Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

Dijon, , France

Site Status

Centre d'investigation clinique 1406 CHU Grenoble

Grenoble, , France

Site Status

Centre d'Investigation Clinique 1403 -CHU Lille

Lille, , France

Site Status

Centre Investigation Clinique 1433 CHRU de NANCY

Nancy, , France

Site Status

Centre d'Investigation Clinique Hôpital Saint Louis

Paris, , France

Site Status

Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

Paris, , France

Site Status

Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier

Paris, , France

Site Status

Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou

Rennes, , France

Site Status

Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

Saint-Denis, , France

Site Status

Département maladie infectieux CHU Saint Etienne

Saint-Etienne, , France

Site Status

Centre d'Investigation Clinique Ile de la Réunion CHU sud

Saint-Pierre, , France

Site Status

Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

Tours, , France

Site Status

Service de Maladies infectieuses et tropicales Centre hospitalier

Cayenne, , French Guiana

Site Status

Countries

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France French Guiana

References

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Matuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaibi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarstrom L, Hatipoglu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarstrom Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Riviere JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schluter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, von Bernuth H, Lermine A, Vidaud M, Boland A, Deleuze JF, Nussbaum R, Kahn-Kirby A, Mentre F, Tubiana S, Gorochov G, Tubach F, Hausfater P; COVID Human Genetic Effort; COVIDeF Study Group; French COVID Cohort Study Group; CoV-Contact Cohort; COVID-STORM Clinicians; COVID Clinicians; Orchestra Working Group; Amsterdam UMC Covid-19 Biobank; NIAID-USUHS COVID Study Group; Meyts I, Zhang SY, Puel A, Notarangelo LD, Boisson-Dupuis S, Su HC, Boisson B, Jouanguy E, Casanova JL, Zhang Q, Abel L, Cobat A. Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8.

Reference Type DERIVED
PMID: 37020259 (View on PubMed)

Other Identifiers

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2020-A00280-39

Identifier Type: REGISTRY

Identifier Source: secondary_id

C20-06

Identifier Type: -

Identifier Source: org_study_id

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