Clinical trial NCT04328129: Household Transmission Investigation Study for COVID-19 in Tropical Regions
Official title: Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infections
Severe Acute Respiratory Syndrome
SARS-CoV Infection
Keywords: SARS-CoV-2
COVID-19
Serology
French Guiana
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de la Guyane
name: Centre Hospitalier Andrée Rosemon de Cayenne
name: Institut Pasteur de la Guadeloupe
name: Centre Hospitalier de la Guadeloupe
name: Institut Pasteur de Nouvelle-Calédonie
name: Centre Hospitalier Territorial de Nouvelle-Calédonie
First posted: 2020-03-31
Enrollment: 245
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of the extent of the virus transmission within households
timeFrame: 2 years
Secondary outcomes:
measure: Characterization of the secondary cases
timeFrame: 2 years
measure: Characterization of the secondary cases
timeFrame: 2 years
measure: In New-Caledonia, evaluation of the extent of the virus transmission within contact persons
timeFrame: 2 years
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier Andrée Rosemon
city: Cayenne
country: French Guiana
facility: Institut Pasteur de la Guyane
city: Les Abymes
country: Guadeloupe
facility: Institut Pasteur de Guadeloupe
city: Nouméa
country: New Caledonia
facility: Institut Pasteur de Nouvelle-Calédonie
Study officials:
affiliation: Institut Pasteur de la Guyane, Head of Epidemiology Unit
name: Claude Flamand, PhD
role: PRINCIPAL_INVESTIGATOR
References: