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

Household Transmission Investigation Study for Coronavirus Disease 2019 (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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Respiratory Syndrome; Coronavirus Infections; SARS-CoV Infection
• Intervention / Treatment: Procedure: Human biological samples

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.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• French Guiana
  • Cayenne, French Guiana
    • Centre Hospitalier Andrée Rosemon
  • Cayenne, French Guiana
    • Institut Pasteur de la Guyane
• Guadeloupe
  • Les Abymes, Guadeloupe
    • Institut Pasteur de Guadeloupe
• New Caledonia
  • Nouméa, New Caledonia
    • Institut Pasteur de Nouvelle-Calédonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary case; Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)	Procedure: Human biological samples; Blood sample; Nasopharyngeal swab.
Experimental: Family contact; Subject who lived in the household of the primary case while the primary case was symptomatic	Procedure: Human biological samples; Blood sample; Nasopharyngeal swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of the secondary cases	The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household	2 years
Characterization of the secondary cases	The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.	2 years
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	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Serology; French Guiana
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: 2020-009 (Other Identifier: VAWNYHS IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No