CoronavirusNCT04322279
Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.
An observational study of Coronavirus, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in 2 countries.
Trial summary
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus
- What is being tested?
- Serology and Sequencing
- How many people
- 81 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 9 Mar 2020to 31 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.
Who may be able to join
- High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
- Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
- Obtaining informed consent.
Who cannot join
- Subject included in the CoV-CONTACT study
- Subject deprived of freedom
- Subject under a legal protective measure
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France15 sites
Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon
Besançon, 25030
Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin
Bordeaux, 33076
Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand
Clermont-Ferrand, 63000
Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne
Dijon, 21 079
Centre d'investigation clinique 1406 CHU Grenoble
Grenoble, 38043
Centre d'Investigation Clinique 1403 -CHU Lille
Lille, 59037
Centre d'Investigation Clinique Hôpital Saint Louis
Paris, 75010
Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard
Paris, 75018
Hôpital Cochin CIC 1417 Bâtiment Lavoisier
Paris, 75679
Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou
Rennes, 35033
Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord
Saint-Denis, 97400
Département maladie infectieux CHU Saint Etienne
Saint-Etienne, 42055
Centre d'Investigation Clinique Ile de la Réunion CHU sud
Saint-Pierre, 97448
Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau
Tours, 37000
Centre Investigation Clinique 1433 CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
French Guiana1 site
Service de Maladies infectieuses et tropicales Centre hospitalier
Cayenne, 97306
About this study
Official title: Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.
Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.
Read more
Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.
Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.
The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.
This include both children and adult subjects, subject without social security, and healthcare workers.
Read the detailed description
Procedures added by the research:
Blood sampling for determination of the presence of SARS-CoV-2 type M immunoglobulins or type G immunoglobulins.
Blood sampling for whole exome sequencing
- Conditions
- Coronavirus
- Being tested
- Serology, Sequencing
- Keywords
- contact subject, high/moderate risk of transmission
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerologyDiagnostic test
SARS-CoV-2 serology
SequencingGenetic
Whole exome sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
Measured: 30 days (+/-7)
Secondary outcomes (2)
Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);
Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
Measured: 30 days (+/-7)
Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.
ELISA, microneutralisation assay
Measured: 365 days (+/-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start9 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Why it stopped: no topics to include
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xavier DUVAL, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322279
- Sponsor's protocol ID
- C20-16
- Other IDs
- 2020-A00609-30
- Status last verified
- Jan 2025
- First submitted
- 24 Mar 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)
- ClinicalTrials.gov ID
- NCT04322279
- Acronym / sponsor ID
- C20-16
- Conditions
- Coronavirus
- Keywords
- contact subject, high/moderate risk of transmission
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no topics to include
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 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.
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.
Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.
Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.
Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.
The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.
This include both children and adult subjects, subject without social security, and healthcare workers.
Detailed description
Procedures added by the research:
Blood sampling for determination of the presence of SARS-CoV-2 type M immunoglobulins or type G immunoglobulins.
Blood sampling for whole exome sequencing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.
Key inclusion criteria (3 listed)
- High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
- Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
- Obtaining informed consent.
Key exclusion criteria (3 listed)
- Subject included in the CoV-CONTACT study
- Subject deprived of freedom
- Subject under a legal protective measure
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 |
|---|---|---|
| SerologySARS-CoV-2 serology | Diagnostic test | – |
| SequencingWhole exome sequencing | Genetic | – |
Primary outcome
Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
Time frame: 30 days (+/-7)
Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
2 secondary outcomes
Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);
Time frame: 30 days (+/-7)
Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.
Time frame: 365 days (+/-30)
Results and safety
The study was stopped early (reason given: no topics to include). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Xavier DUVAL, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in 2 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 3 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: stopped early, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, 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 was stopped early (reason given: no topics to include). Results are not available in the source record.
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?
Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case. (time frame: 30 days (+/-7)). 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 22 Jan 2025.