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Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID19.

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: NCT04322279
Recruitment Status : Recruiting
First Posted : March 26, 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.

In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.

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, subject without social security, and healthcare workers.


Condition or disease Intervention/treatment
Coronavirus Diagnostic Test: Serology Genetic: Sequencing

Detailed Description:

Procedures added by the research:

Blood sampling for determination of the presence of SARS-CoV-2 type M immunoglobulins or type G immunoglobulins.

Blood sampling for whole exome sequencing

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Serology
    SARS-CoV-2 serology
  • Genetic: Sequencing
    Whole exome sequencing


Primary Outcome Measures :
  1. Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case. [ Time Frame: 30 days (+/-7) ]
    Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay


Secondary Outcome Measures :
  1. Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7); [ Time Frame: 30 days (+/-7) ]
    Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

  2. 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 assay


Biospecimen Retention:   Samples With DNA
Blood samples


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.
Criteria

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 included in the CoV-CONTACT study
  • 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): NCT04322279


Contacts
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Contact: Xavier DUVAL, MD +33 1 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: NCT04322279    
Other Study ID Numbers: C20-16
2020-A00609-30 ( Registry Identifier: RCB-ID )
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: March 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