Coronavirus InfectionsEPI-COVID-19NCT04328129
Household Transmission Investigation Study for COVID-19 in Tropical Regions
A study testing Human biological samples in people with Coronavirus Infections and Severe Acute Respiratory Syndrome, run by Institut Pasteur at 4 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Severe Acute Respiratory Syndrome, SARS-CoV Infection
- What is being tested?
- Human biological samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 23 Mar 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to consent
- Person under guardianship or curatorship
- Known pathology or a health problem contraindicated with the collect of blood sample.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
French Guiana2 sites
Centre Hospitalier Andrée Rosemon
Cayenne
Institut Pasteur de la Guyane
Cayenne
New Caledonia1 site
Institut Pasteur de Nouvelle-Calédonie
Noumea
About this study
Official title: 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.
Read the 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.
- Being tested
- Human biological samples
- Keywords
- SARS-CoV-2, COVID-19, Serology, French Guiana
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human biological samplesProcedure or surgery
- Blood sample
- Nasopharyngeal swab.
| Study group | Role | What they receive |
|---|---|---|
| Primary case | Experimental | Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR) Receives: Procedure: Human biological samples |
| Family contact | Experimental | Subject who lived in the household of the primary case while the primary case was symptomatic Receives: Procedure: Human biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Characterization of the secondary cases
The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household
Measured: 2 years
Characterization of the secondary cases
The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start23 Mar 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Claude Flamand, PhD, Principal investigator, Institut Pasteur de la Guyane, Head of Epidemiology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328129
- Sponsor's protocol ID
- 2020-009
- Acronym
- EPI-COVID-19
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions
- ClinicalTrials.gov ID
- NCT04328129
- Acronym / sponsor ID
- EPI-COVID-19 / 2020-009
- Keywords
- SARS-CoV-2, COVID-19, Serology, French Guiana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- 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
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary case | Experimental | Procedure: Human biological samplesSubject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR) |
| Family contact | Experimental | Procedure: Human biological samplesSubject who lived in the household of the primary case while the primary case was symptomatic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Inability to consent
- Person under guardianship or curatorship
- Known pathology or a health problem contraindicated with the collect of blood sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human biological samples* Blood sample * Nasopharyngeal swab. | Procedure or surgery | Family contact, Primary case |
Primary outcome
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
3 secondary outcomes
Characterization of the secondary cases
Time frame: 2 years
Characterization of the secondary cases
Time frame: 2 years
In New-Caledonia, evaluation of the extent of the virus transmission within contact persons
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Flamand, PhD principal investigator
Institut Pasteur de la Guyane, Head of Epidemiology Unit
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human biological samples in people with Coronavirus Infections and Severe Acute Respiratory Syndrome, run by Institut Pasteur at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in French Guiana, Guadeloupe, New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the extent of the virus transmission within households (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.