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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Human biological samples
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coronavirus Infections focused on measuring SARS-CoV-2, COVID-19, Serology, French Guiana

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary case

Family contact

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Characterization of the secondary cases
The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household
Characterization of the secondary cases
The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.
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

Full Information

First Posted
March 23, 2020
Last Updated
February 14, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT04328129
Brief Title
Household Transmission Investigation Study for COVID-19 in Tropical Regions
Acronym
EPI-COVID-19
Official Title
Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections, Severe Acute Respiratory Syndrome, SARS-CoV Infection
Keywords
SARS-CoV-2, COVID-19, Serology, French Guiana

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary case
Arm Type
Experimental
Arm Description
Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)
Arm Title
Family contact
Arm Type
Experimental
Arm Description
Subject who lived in the household of the primary case while the primary case was symptomatic
Intervention Type
Procedure
Intervention Name(s)
Human biological samples
Intervention Description
Blood sample Nasopharyngeal swab.
Primary Outcome Measure Information:
Title
Evaluation of the extent of the virus transmission within households
Description
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 Outcome Measure Information:
Title
Characterization of the secondary cases
Description
The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household
Time Frame
2 years
Title
Characterization of the secondary cases
Description
The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.
Time Frame
2 years
Title
In New-Caledonia, evaluation of the extent of the virus transmission within contact persons
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Flamand, PhD
Organizational Affiliation
Institut Pasteur de la Guyane, Head of Epidemiology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Andrée Rosemon
City
Cayenne
Country
French Guiana
Facility Name
Institut Pasteur de la Guyane
City
Cayenne
Country
French Guiana
Facility Name
Institut Pasteur de Guadeloupe
City
Les Abymes
Country
Guadeloupe
Facility Name
Institut Pasteur de Nouvelle-Calédonie
City
Nouméa
Country
New Caledonia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Household Transmission Investigation Study for COVID-19 in Tropical Regions

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