NCT04328129

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

March 23, 2020

Last Update Submit

February 14, 2022

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeSARS-CoV Infection

Keywords

SARS-CoV-2COVID-19SerologyFrench Guiana

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (3)

  • Characterization of the secondary cases

    2 years

  • Characterization of the secondary cases

    2 years

  • In New-Caledonia, evaluation of the extent of the virus transmission within contact persons

    2 years

Study Arms (2)

Primary case

EXPERIMENTAL

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

Procedure: Human biological samples

Family contact

EXPERIMENTAL

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

Procedure: Human biological samples

Interventions

Human biological samplesPROCEDURE

* Blood sample * Nasopharyngeal swab.

Family contactPrimary case

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to consent
  • Person under guardianship or curatorship
  • Known pathology or a health problem contraindicated with the collect of blood sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Andrée Rosemon

Cayenne, French Guiana

Location

Institut Pasteur de la Guyane

Cayenne, French Guiana

Location

Institut Pasteur de Guadeloupe

Les Abymes, Guadeloupe

Location

Institut Pasteur de Nouvelle-Calédonie

Noumea, New Caledonia

Location

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Claude Flamand, PhD

    Institut Pasteur de la Guyane, Head of Epidemiology Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 31, 2020

Study Start

March 23, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)GU(1)FR(2)