Household Transmission Investigation Study for COVID-19 in Tropical Regions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions

Conditions
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Coronavirus Infections, Severe Acute Respiratory Syndrome, SARS-CoV Infection

Intervention / Treatment
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* Procedure: Human biological samples


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary case<br>Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR) | Procedure: Human biological samples<br>* Blood sample Nasopharyngeal swab.<br>|
| Experimental: Family contact<br>Subject who lived in the household of the primary case while the primary case was symptomatic | Procedure: Human biological samples<br>* Blood sample Nasopharyngeal swab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the extent of the virus transmission within households | The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the secondary cases | The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household | 2 years | 
| Characterization of the secondary cases | The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection. | 2 years | 
| In New-Caledonia, evaluation of the extent of the virus transmission within contact persons | The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Serology, French Guiana