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

NCT04259892 | Completed

• 2 other identifiers: C20-062020-A00280-39
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 15

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.

Conditions

Coronavirus

Keywords

contact subject; high/moderate risk of transmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion

  12 days (+/-2)

• Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection

  12 days (+/-2)

• Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection

  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)

Interventions

2019-nCoV PCR BIOLOGICAL

Nasopharyngeal swabs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subject deprived of freedom
• Subject under a legal protective measure

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (16)

Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

Besançon, 25030, France

Location

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

Bordeaux, 33076, France

Location

Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

Dijon, 21 079, France

Location

Centre d'investigation clinique 1406 CHU Grenoble

Grenoble, 38043, France

Location

Centre d'Investigation Clinique 1403 -CHU Lille

Lille, 59037, France

Location

Centre Investigation Clinique 1433 CHRU de NANCY

Nancy, 54511, France

Location

Centre d'Investigation Clinique Hôpital Saint Louis

Paris, 75010, France

Location

Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier

Paris, 75679, France

Location

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

Rennes, 35033, France

Location

Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

Saint-Denis, 97400, France

Location

Département maladie infectieux CHU Saint Etienne

Saint-Etienne, 42055, France

Location

Centre d'Investigation Clinique Ile de la Réunion CHU sud

Saint-Pierre, 97448, France

Location

Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

Tours, 37000, France

Location

Service de Maladies infectieuses et tropicales Centre hospitalier

Cayenne, 97306, French Guiana

Location

Related Publications (4)

• Le Hingrat Q, Visseaux B, Laouenan C, Tubiana S, Bouadma L, Yazdanpanah Y, Duval X, Burdet C, Ichou H, Damond F, Bertine M, Benmalek N, Choquet C, Timsit JF, Ghosn J, Charpentier C, Descamps D, Houhou-Fidouh N; French COVID cohort management committee; CoV-CONTACT study group. Corrigendum to 'detection of SARS-CoV-2 N-antigen in blood during acute COVID-19 provides a sensitive new marker and new testing alternatives'. Clin Microbiol Infect. 2021 Nov;27(11):1713. doi: 10.1016/j.cmi.2021.09.034. Epub 2021 Oct 2. No abstract available.

  PMID: 34607001 BACKGROUND

• Bastard P, Rosen LB, Zhang Q, Michailidis E, Hoffmann HH, Zhang Y, Dorgham K, Philippot Q, Rosain J, Beziat V, Manry J, Shaw E, Haljasmagi L, Peterson P, Lorenzo L, Bizien L, Trouillet-Assant S, Dobbs K, de Jesus AA, Belot A, Kallaste A, Catherinot E, Tandjaoui-Lambiotte Y, Le Pen J, Kerner G, Bigio B, Seeleuthner Y, Yang R, Bolze A, Spaan AN, Delmonte OM, Abers MS, Aiuti A, Casari G, Lampasona V, Piemonti L, Ciceri F, Bilguvar K, Lifton RP, Vasse M, Smadja DM, Migaud M, Hadjadj J, Terrier B, Duffy D, Quintana-Murci L, van de Beek D, Roussel L, Vinh DC, Tangye SG, Haerynck F, Dalmau D, Martinez-Picado J, Brodin P, Nussenzweig MC, Boisson-Dupuis S, Rodriguez-Gallego C, Vogt G, Mogensen TH, Oler AJ, Gu J, Burbelo PD, Cohen JI, Biondi A, Bettini LR, D'Angio M, Bonfanti P, Rossignol P, Mayaux J, Rieux-Laucat F, Husebye ES, Fusco F, Ursini MV, Imberti L, Sottini A, Paghera S, Quiros-Roldan E, Rossi C, Castagnoli R, Montagna D, Licari A, Marseglia GL, Duval X, Ghosn J; HGID Lab; NIAID-USUHS Immune Response to COVID Group; COVID Clinicians; COVID-STORM Clinicians; Imagine COVID Group; French COVID Cohort Study Group; Milieu Interieur Consortium; CoV-Contact Cohort; Amsterdam UMC Covid-19 Biobank; COVID Human Genetic Effort; Tsang JS, Goldbach-Mansky R, Kisand K, Lionakis MS, Puel A, Zhang SY, Holland SM, Gorochov G, Jouanguy E, Rice CM, Cobat A, Notarangelo LD, Abel L, Su HC, Casanova JL. Autoantibodies against type I IFNs in patients with life-threatening COVID-19. Science. 2020 Oct 23;370(6515):eabd4585. doi: 10.1126/science.abd4585. Epub 2020 Sep 24.

  PMID: 32972996 RESULT

• Tubiana S, Burdet C, Houhou N, Thy M, Manchon P, Blanquart F, Charpentier C, Guedj J, Alavoine L, Behillil S, Leclercq A, Lucet JC, Yazdanpanah Y, Attia M, Demeret C, Rose T, Bielicki JA, Bruijning-Verhagen P, Goossens H, Descamps D, van der Werf S, Lina B, Duval X; CoVCONTACT study group; Principal investigator; Sponsor: Inserm. High-risk exposure without personal protective equipment and infection with SARS-CoV-2 in-hospital workers - The CoV-CONTACT cohort. J Infect. 2021 May;82(5):186-230. doi: 10.1016/j.jinf.2021.01.026. Epub 2021 Feb 3. No abstract available.

  PMID: 33545165 RESULT

• 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.

  PMID: 37020259 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs

MeSH Terms

Conditions

Coronavirus Infections

Interventions

2019-novel coronavirus real-time reverse transcriptase diagnostic panel

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xavier Duval, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: February 4, 2020
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: June 15, 2026

Record last verified: 2024-07

Locations

FR (15)