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Completed

NCT Number: NCT04328129

Household Transmission Investigation Study for COVID-19 in Tropical Regions

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Andrée Rosemon, Cayenne, French Guiana

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human biological samples

Procedure
  • Blood sample
  • Nasopharyngeal swab.

Primary outcomes

  1. Evaluation of the extent of the virus transmission within households

    Time frame: 2 years

    The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus

Secondary outcomes

  1. Characterization of the secondary cases

    Time frame: 2 years

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

  2. Characterization of the secondary cases

    Time frame: 2 years

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

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

    Time frame: 2 years

    The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Centre Hospitalier Andrée Rosemon de Cayenne
  • Centre Hospitalier Territorial de Nouvelle-Calédonie
  • Centre Hospitalier de la Guadeloupe
  • Institut Pasteur de Nouvelle-Calédonie
  • Institut Pasteur de la Guadeloupe
  • Institut Pasteur de la Guyane

Registry information

Official study title

Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions

Acronym: EPI-COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2020
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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