Coronavirus InfectionEPI-COVID-POPNCT04490850
COVID-19 Seroprevalence Study in French Guiana
A study testing Blood sample in people with Coronavirus Infection and Severe Acute Respiratory Syndrome, run by Institut Pasteur at 5 sites in French Guiana.
Trial summary
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Severe Acute Respiratory Syndrome, SARS-CoV Infection
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,541 participants
- Where
- 5 sitesFrench Guiana
- Study dates
- 15 Jul 2020to 24 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
- Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19;
- 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
5 sites in 1 country.
5 sites in 1 country
French Guiana5 sites
Centre Hospitalier Andrée Rosemon
Cayenne
Laboratoire de biologie méicale, Institut Pasteur de la Guyane
Cayenne
Laboratoires Eurofins Guyane
Cayenne
Laboratoire de biologie médicale de Kourou
Kourou
Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni
Saint-Laurent-du-Maroni
About this study
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
Read the detailed description
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
This study is a interventional study that present minimal risks and constraints.
The results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.
- Being tested
- Blood sample
- 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.
Blood sampleProcedure or surgery
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Blood sample Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the COVID-19 immunity of the population
The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies
Measured: 1 year
Secondary outcomes (1)
Evaluation of the level of asymptomatic and pauci-symptomatic infections
The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start15 Jul 2020
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de la Guyane, Laboratoire de biologie médicale, Institut Pasteur de la Guyane, Laboratoire de biologie médicale de Kourou, French Guiana, Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana, Eurofins, Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana
- 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
- NCT04490850
- Sponsor's protocol ID
- 2020-048
- Acronym
- EPI-COVID-POP
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- COVID-19 Seroprevalence Study in French Guiana
- ClinicalTrials.gov ID
- NCT04490850
- Acronym / sponsor ID
- EPI-COVID-POP / 2020-048
- Keywords
- SARS-CoV-2, COVID-19, Serology, French Guiana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,541 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de la Guyane, Laboratoire de biologie médicale, Institut Pasteur de la Guyane, Laboratoire de biologie médicale de Kourou, French Guiana, Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana, Eurofins, Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 29 Jul 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.
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
Detailed description
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
This study is a interventional study that present minimal risks and constraints.
The results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Blood sampleBlood sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19;
- State of health compatible with a blood sample as defined in the protocol
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 |
|---|---|---|
| Blood sampleBlood sample | Procedure or surgery | Participants |
Primary outcome
Measure of the COVID-19 immunity of the population
Time frame: 1 year
The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies
1 secondary outcome
Evaluation of the level of asymptomatic and pauci-symptomatic infections
Time frame: 1 year
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.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Coronavirus Infection and Severe Acute Respiratory Syndrome, run by Institut Pasteur at 5 sites in French Guiana.
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 2 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 5 sites in French Guiana. 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?
Measure of the COVID-19 immunity of the population (time frame: 1 year). 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.