Household Transmission Investigation Study for COVID-19 in Tropical Regions
- Conditions
- Coronavirus InfectionsSevere Acute Respiratory SyndromeSARS-CoV Infection
- Interventions
- Procedure: Human biological samples
- Registration Number
- NCT04328129
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- 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.
- Inability to consent
- Person under guardianship or curatorship
- Known pathology or a health problem contraindicated with the collect of blood sample.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary case Human biological samples Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR) Family contact Human biological samples Subject who lived in the household of the primary case while the primary case was symptomatic
- Primary Outcome Measures
Name Time Method Evaluation of the extent of the virus transmission within households 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
Name Time Method In New-Caledonia, evaluation of the extent of the virus transmission within contact persons 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
Characterization of the secondary cases 2 years The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.
Trial Locations
- Locations (4)
Institut Pasteur de Nouvelle-Calédonie
🇳🇨Nouméa, New Caledonia
Institut Pasteur de Guadeloupe
🇬🇵Les Abymes, Guadeloupe
Centre Hospitalier Andrée Rosemon
🇬🇫Cayenne, French Guiana
Institut Pasteur de la Guyane
🇬🇫Cayenne, French Guiana