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

Sponsor

Institut Pasteur (Industry)

Overall Status

Completed

CT.gov ID

NCT04328129

Collaborator

Institut Pasteur de la Guyane (Other), Centre Hospitalier Andrée Rosemon de Cayenne (Other), Institut Pasteur de la Guadeloupe (Other), Centre Hospitalier de la Guadeloupe (Other), Institut Pasteur de Nouvelle-Calédonie (Other), Centre Hospitalier Territorial de Nouvelle-Calédonie (Other)

245

Enrollment

Locations

Arms

18.3

Actual Duration (Months)

61.3

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection	Procedure: Human biological samples	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

245 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Mar 23, 2020

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evaluation of the extent of the virus transmission within households [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 Outcome Measures

Characterization of the secondary cases [2 years]
The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household
Characterization of the secondary cases [2 years]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	Country
1	Centre Hospitalier Andrée Rosemon	Cayenne	French Guiana
2	Institut Pasteur de la Guyane	Cayenne	French Guiana
3	Institut Pasteur de Guadeloupe	Les Abymes	Guadeloupe
4	Institut Pasteur de Nouvelle-Calédonie	Nouméa	New Caledonia