Household Transmission Investigation Study for COVID-19 in Tropical Regions

SARS-CoV Infection Clinical Trial

— EPI-COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328129
• Other study ID #: 2020-009
• Status: Completed
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• COVID-19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Procedure:
• Human biological samples
Blood sample Nasopharyngeal swab.

Locations

Country	Name	City	State
French Guiana	Centre Hospitalier Andrée Rosemon	Cayenne
French Guiana	Institut Pasteur de la Guyane	Cayenne
Guadeloupe	Institut Pasteur de Guadeloupe	Les Abymes
New Caledonia	Institut Pasteur de Nouvelle-Calédonie	Nouméa

Sponsors (7)

Lead Sponsor	Collaborator
Institut Pasteur	Centre Hospitalier Andrée Rosemon de Cayenne, Centre Hospitalier de la Guadeloupe, Centre Hospitalier Territorial de Nouvelle-Calédonie, Institut Pasteur de la Guadeloupe, Institut Pasteur de la Guyane, Institut Pasteur de Nouvelle-Calédonie

Countries where clinical trial is conducted

French Guiana,  Guadeloupe,  New Caledonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Characterization of the secondary cases	The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.	2 years
Secondary	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