Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Pasteur
- Enrollment
- 245
- Locations
- 4
- Primary Endpoint
- Evaluation of the extent of the virus transmission within households
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- In New-Caledonia, evaluation of the extent of the virus transmission within contact persons(2 years)
- Characterization of the secondary cases(2 years)