Household Transmission Investigation Study for COVID-19 in Tropical Regions

NCT ID: NCT04328129

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Primary case

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

Group Type EXPERIMENTAL

Human biological samples

Intervention Type PROCEDURE

* Blood sample
* Nasopharyngeal swab.

Family contact

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

Group Type EXPERIMENTAL

Human biological samples

Intervention Type PROCEDURE

* Blood sample
* Nasopharyngeal swab.

Interventions

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Human biological samples

* Blood sample
* Nasopharyngeal swab.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur de la Guyane

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Andrée Rosemon de Cayenne

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de la Guadeloupe

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de la Guadeloupe

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de Nouvelle-Calédonie

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Territorial de Nouvelle-Calédonie

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claude Flamand, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de la Guyane, Head of Epidemiology Unit

Locations

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Centre Hospitalier Andrée Rosemon

Cayenne, , French Guiana

Site Status

Institut Pasteur de la Guyane

Cayenne, , French Guiana

Site Status

Institut Pasteur de Guadeloupe

Les Abymes, , Guadeloupe

Site Status

Institut Pasteur de Nouvelle-Calédonie

Noumea, , New Caledonia

Site Status

Countries

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French Guiana Guadeloupe New Caledonia

Other Identifiers

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2020-009

Identifier Type: -

Identifier Source: org_study_id

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