Household Transmission Investigation Study for COVID-19 in Tropical Regions (EPI-COVID-19)

Pasteur Institute

Status: Completed

Conditions: SARS-CoV Infection; Severe Acute Respiratory Syndrome; Coronavirus Infections

Treatments: Procedure: Human biological samples

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04328129

2020-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Primary case

Experimental group

Description:

Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)

Treatment:

Procedure: Human biological samples

Family contact

Experimental group

Description:

Subject who lived in the household of the primary case while the primary case was symptomatic

Treatment:

Procedure: Human biological samples