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CoronavirusCov-CONTACTNCT04259892

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

An observational study of Coronavirus, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronavirus
What is being tested?
2019-nCoV PCR
How many people
324 participants
Where
16 sitesin 2 countries
Study dates
4 Feb 2020to 2 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

France15 sites

  • Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

    Besançon, 25030

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

    Bordeaux, 33076

  • Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

    Clermont-Ferrand, 63000

  • Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

    Dijon, 21 079

  • Centre d'investigation clinique 1406 CHU Grenoble

    Grenoble, 38043

  • Centre d'Investigation Clinique 1403 -CHU Lille

    Lille, 59037

  • Centre Investigation Clinique 1433 CHRU de NANCY

    Nancy, 54511

  • Centre d'Investigation Clinique Hôpital Saint Louis

    Paris, 75010

  • Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

    Paris, 75018

  • Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier

    Paris, 75679

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

    Rennes, 35033

  • Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

    Saint-Denis, 97400

  • Département maladie infectieux CHU Saint Etienne

    Saint-Etienne, 42055

  • Centre d'Investigation Clinique Ile de la Réunion CHU sud

    Saint-Pierre, 97448

  • Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

    Tours, 37000

Other trials in France

French Guiana1 site

  • Service de Maladies infectieuses et tropicales Centre hospitalier

    Cayenne, 97306

Other trials in French Guiana

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Coronavirus
Being tested
2019-nCoV PCR
Keywords
contact subject, high/moderate risk of transmission
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2019-nCoV PCRBiological

    Nasopharyngeal swabs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 days (+/-2)

Secondary outcomes (7)

  1. 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, ...)

    Measured: 12 days (+/-2)

  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

    Measured: 12 days (+/-2)

  3. 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, ...)

    Measured: 12 days (+/-2)

  4. 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, ...)

    Measured: 12 days (+/-2)

  5. 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

    Measured: 30 days (+/-7)

  6. Host genetic variants

    Whole exome sequencing

    Measured: 1 day

  7. The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

    ELISA, microneutralisation essay

    Measured: 365 days (+/-30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start4 Feb 2020
  3. Primary completion2 Aug 2021
  4. Study completion2 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259892
Sponsor's protocol ID
C20-06
Other IDs
2020-A00280-39
Acronym
Cov-CONTACT
Status last verified
Jul 2024
First submitted
5 Feb 2020
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34607001

  • 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.

    PubMed 32972996

  • 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.

    PubMed 33545165

  • 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.

    PubMed 37020259

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 days (+/-2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259892, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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