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CompletedNCT04328129EPI-COVID-19Updated Feb 15, 2022

Household Transmission Investigation Study for COVID-19 in Tropical Regions

An interventional study of Human biological samples in Coronavirus Infections, Severe Acute Respiratory Syndrome and SARS-CoV Infection, sponsored by Institut Pasteur. Completed at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Institut Pasteur · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
245
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronavirus Infections
  • Severe Acute Respiratory Syndrome
  • SARS-CoV Infection

Keywords

  • SARS-CoV-2
  • COVID-19
  • Serology
  • French Guiana
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 245 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    Primary case

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

    Procedure: Human biological samples

  • Experimental
    Family contact

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

    Procedure: Human biological samples

Interventions

  • ProcedureHuman biological samples

    * Blood sample * Nasopharyngeal swab.

06

What researchers measure

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

    Time frame: 2 years

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

4 sites
  • 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
    Nouméa, New Caledonia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04328129
Lead sponsor
Institut Pasteur
Collaborators
Institut Pasteur de la Guyane, Centre Hospitalier Andrée Rosemon de Cayenne, Institut Pasteur de la Guadeloupe, Centre Hospitalier de la Guadeloupe, Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
Responsible party
Sponsor
First posted
Mar 31, 2020
Start date
Mar 23, 2020
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Feb 15, 2022

Study contacts

Claude Flamand, PhD
principal investigator · Institut Pasteur de la Guyane, Head of Epidemiology Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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