Infection ViralNCT04664296
COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults (Dyn3CEA_Nosocor)
An observational study of Infection Viral, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Infection Viral
- What is being tested?
- Review of medical patient file and Phone call interview
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2020to 23 Mar 2021
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital-based population of children and adults: * Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey * Hospitalized adults, 18 years and above, 50 matched subjects
Who may be able to join
- Children after hospitalized in Hospices Civils de Lyon with Polymerase Chain Reaction (PCR) positive SARS-CoV2,
- Adults hospitalized in Hospices Civils de Lyon and included in the NOSO-COR study with matching criteria described below.
- Matching will be performed on family age characteristics and on the period of contamination included in the containment period to minimize bias, and if possible frequency matching according to admission in Intensive Care Unit ICU/Pediatric Intensive Care Unit (PICU), and to family structure (n of children / n of adults in the family).
Who cannot join
- Any patient suspected of nosocomial infection.
- Any patient death during the Covid-19 infection.
- Any adult patient without children living home.
- Opposition to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults
Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.
- Conditions
- Infection Viral
- Being tested
- Review of medical patient file, Phone call interview
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of medical patient fileOther
Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.
Phone call interviewOther
less than 15 minutes phone call
| Study group | Role | What they receive |
|---|---|---|
| Children | Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey Receives: Other: Review of medical patient file | |
| Adults | Hospitalized adults, 18 years and above, 50 matched subjects Receives: Other: Phone call interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of possible contaminants, adults, adolescents and children with Covid-19
To describe the age category of the 1st possible contaminant in the index case to show the preponderance of possible adult and adolescent contaminants in the SARS-Cov-2 contamination.
Percentage of possible contaminants, adults, adolescents and children, in matched children and adults with Covid-19.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start21 Dec 2020
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664296
- Sponsor's protocol ID
- 69HCL20_1100
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2020
- Last updated
- 26 Apr 2021
- 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 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults
- ClinicalTrials.gov ID
- NCT04664296
- Acronym / sponsor ID
- 69HCL20_1100
- Conditions
- Infection Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 11 Dec 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.
Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: Review of medical patient fileHospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey |
| Adults | – | Other: Phone call interviewHospitalized adults, 18 years and above, 50 matched subjects |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital-based population of children and adults: * Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey * Hospitalized adults, 18 years and above, 50 matched subjects
Key inclusion criteria (3 listed)
- Children after hospitalized in Hospices Civils de Lyon with Polymerase Chain Reaction (PCR) positive SARS-CoV2,
- Adults hospitalized in Hospices Civils de Lyon and included in the NOSO-COR study with matching criteria described below.
Key exclusion criteria (4 listed)
- Any patient suspected of nosocomial infection.
- Any patient death during the Covid-19 infection.
- Any adult patient without children living home.
- Opposition to participate.
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 |
|---|---|---|
| Review of medical patient fileReview of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing. | Other | Children |
| Phone call interviewless than 15 minutes phone call | Other | Adults |
Primary outcome
Percentage of possible contaminants, adults, adolescents and children with Covid-19
Time frame: at inclusion
To describe the age category of the 1st possible contaminant in the index case to show the preponderance of possible adult and adolescent contaminants in the SARS-Cov-2 contamination. Percentage of possible contaminants, adults, adolescents and children, in matched children and adults with Covid-19.
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 26 Apr 2021.
Related trials for Infection Viral
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral, run by Hospices Civils de Lyon at 1 site in France.
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 4 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Percentage of possible contaminants, adults, adolescents and children with Covid-19 (time frame: at inclusion). 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 26 Apr 2021.