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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04259892
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease Intervention/treatment
Coronavirus Biological: 2019-nCoV PCR

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.

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Study Type : Observational
Estimated Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : October 4, 2020
Estimated Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: 2019-nCoV PCR
    Nasopharyngeal swabs


Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Nasopharyngeal swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259892


Contacts
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Contact: Xavier Duval, MD 01 40 25 71 48 xavier.duval@aphp.fr
Contact: Bruno Lina, MD bruno.lina@chu-lyon.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Xavier Duval, MD Institut National de la Santé Et de la Recherche Médicale, France
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04259892    
Other Study ID Numbers: C20-06
2020-A00280-39 ( Registry Identifier: RCB ID )
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
contact subject
high/moderate risk of transmission
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases