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Completed

NCT Number: NCT04259892

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

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.

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Key information

Conditions

Coronavirus Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

2019-nCoV PCR

Biological

Nasopharyngeal swabs

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.

    Time frame: 12 days (+/-2)

    PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Secondary outcomes

  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.

    Time frame: 12 days (+/-2)

    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, ...)

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

    Time frame: 12 days (+/-2)

    nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

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

    Time frame: 12 days (+/-2)

    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, ...)

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

    Time frame: 12 days (+/-2)

    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, ...)

  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

    Time frame: 30 days (+/-7)

    ELISA, microneutralisation essay

  6. Host genetic variants

    Time frame: 1 day

    Whole exome sequencing

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

    Time frame: 365 days (+/-30)

    ELISA, microneutralisation essay

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: Cov-CONTACT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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