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Household Transmission Investigation Study for COVID-19 in Tropical Regions (EPI-COVID-19)

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: NCT04328129
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
Institut Pasteur de la Guyane
Centre Hospitalier Andrée Rosemon de Cayenne
Institut Pasteur de la Guadeloupe
Centre Hospitalier de la Guadeloupe
Institut Pasteur de Nouvelle-Calédonie
Centre Hospitalier Territorial de Nouvelle Calédonie
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:
This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.

Condition or disease Intervention/treatment Phase
Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection Procedure: Human biological samples Not Applicable

Detailed Description:

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.

Subjects will be assessed (questionnaires and sampling) in their homes. Subjects will be asked to attend study visits at days 0, 7, 14, 21, 28, 60, 90, 180 and 360.

The primary objective of the study is to evaluate the rate of intra-household secondary transmission of the virus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 23, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary case
Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)
Procedure: Human biological samples
  • Blood sample
  • Nasopharyngeal swab.

Experimental: Family contact
Subject who lived in the household of the primary case while the primary case was symptomatic
Procedure: Human biological samples
  • Blood sample
  • Nasopharyngeal swab.




Primary Outcome Measures :
  1. Evaluation of the extent of the virus transmission within households [ Time Frame: 2 years ]
    The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus


Secondary Outcome Measures :
  1. Characterization of the secondary cases [ Time Frame: 2 years ]
    The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

  2. Characterization of the secondary cases [ Time Frame: 2 years ]
    The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

  3. In New-Caledonia, evaluation of the extent of the virus transmission within contact persons [ Time Frame: 2 years ]
    The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus



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:   Yes
Criteria

Inclusion Criteria:

  • Primary case: laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR),

or Family contact in French Guiana and Guadeloupe: person who lived in the same household as the primary case of COVID-19 when the primary case was symptomatic. A household is defined as a group of people (2 or more) living in the same accommodation (excluding residential institutions such as boarding schools, dormitories, hostels, prisons, other communities hosting grouped people),

or Close contact in New-Caledonia: any individual who was in contact with a primary case, in his/her family/living environment, work/school, friends/leisure or means of transport, when the primary case was symptomatic or presymptomatic,

  • Affiliated or beneficiary of a social security system
  • Informed consent prior to initiation of any study procedures from subject (or legally authorized representative)
  • State of health compatible with a blood sample as defined in the protocol.

Exclusion Criteria:

  • Inability to consent
  • Person under guardianship or curatorship
  • Known pathology or a health problem contraindicated with the collect of blood sample.

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): NCT04328129


Contacts
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Contact: Claude Flamand, Phd +33 5 94 29 26 15 cflamand@pasteur-cayenne.fr
Contact: Dominique Rousset, MD +33 5 94 29 26 09 drousset@pasteur-cayenne.fr

Locations
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French Guiana
Centre Hospitalier Andrée Rosemon Enrolling by invitation
Cayenne, French Guiana
Institut Pasteur de la Guyane Recruiting
Cayenne, French Guiana
Contact: Claude Flamand, PhD    +33 5 94 29 26 15    cflamand@pasteur-cayenne.fr   
Contact: Dominique Rousset, MD    +33 5 94 29 26 09    drousset@pasteur-cayenne.fr   
Guadeloupe
Institut Pasteur de Guadeloupe Not yet recruiting
Les Abymes, Guadeloupe
Contact: Stéphanie Guyomard-Rabenrina, MD         
Contact       sguyomard@pasteur-guadeloupe.fr   
New Caledonia
Institut Pasteur de Nouvelle-Calédonie Recruiting
Nouméa, New Caledonia
Contact: Myrielle Dupont-Rouzeyrol, PhD         
Contact       mdupont@pasteur.nc   
Sponsors and Collaborators
Institut Pasteur
Institut Pasteur de la Guyane
Centre Hospitalier Andrée Rosemon de Cayenne
Institut Pasteur de la Guadeloupe
Centre Hospitalier de la Guadeloupe
Institut Pasteur de Nouvelle-Calédonie
Centre Hospitalier Territorial de Nouvelle Calédonie
Investigators
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Principal Investigator: Claude Flamand, PhD Institut Pasteur de la Guyane, Head of Epidemiology Unit
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT04328129    
Other Study ID Numbers: 2020-009
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Pasteur:
SARS-CoV-2
COVID-19
Serology
French Guiana
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases