Household Transmission Investigation Study for COVID-19 in Tropical Regions

Institut Pasteur245 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

245

Conditions

Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection

Interventions

Human biological samplesPROCEDURE

* Blood sample * Nasopharyngeal swab.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Centre Hospitalier Andrée Rosemon

Cayenne, French Guiana

Institut Pasteur de la Guyane

Cayenne, French Guiana

Institut Pasteur de Guadeloupe

Les Abymes, Guadeloupe

Institut Pasteur de Nouvelle-Calédonie

Noumea, New Caledonia

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Characterization of the secondary cases

The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

Time frame: 2 years

Characterization of the secondary cases

The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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