COVID-19 PandemicPedia-CovNCT06167980
Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021
An observational study of COVID-19 Pandemic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- COVID-19 Pandemic
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to Dec 2023
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subject aged from 1 month to 18 years , hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021.
Who may be able to join
- Subject aged from 1 month to 18 years
- Hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021
- Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research
- Parental authority having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.
Who cannot join
- Subject or their parental authority having expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
Strasbourg, 67091
Laurence WEISS, MD, 33 3 88 12 83 95, laurence.weiss@chru-strasbourg.fr
Olivier LINTZ, MD, 33 3 88 12 83 95, olivier.lintz@chru-strasbourg.fr
About this study
Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. These are caused by a previously unknown coronavirus, initially named 2019-nCoV then SARS-CoV-2, which was identified on January 7, 2020 in the Bronchoalveolar Lavage (BAL) of patients hospitalized in China. As for the first European cases, they were diagnosed in France on January 24, 2020.
A Chinese study published in April 2020 (4) concerning adult patients showed that 14% of these cases could be defined as severe and that 5% of cases could be defined as critical.
Read more
Another Chinese study showed that all children, regardless of age, could be infected and that asymptomatic, mild and moderate cases accounted for more than 90% of cases.
In France, the Covid-19 epidemic hit Alsace hard from March 2020, mainly due to the cluster formed by the evangelical assembly of the Christian Open Door Church taking place from February 17 to 21 in Mulhouse in the Haut-Rhin.
Thus, it is interesting to study pediatric patients hospitalized for Covid-19 in Alsace during 2020 in order to discover the clinical characteristics of these patients.
Read the detailed description
The main objective of this study is to retrospectively describe the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021, both in conventional service and in continuing care or intensive care.
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19 Pandemic, SARS-COV-2, COVID-19 Virus Disease, Pediatric patients
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021
Measured: Files analysed retrospectively from period from January 1, 2020 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start17 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167980
- Sponsor's protocol ID
- 8520
- Acronym
- Pedia-Cov
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021
- ClinicalTrials.gov ID
- NCT06167980
- Acronym / sponsor ID
- Pedia-Cov / 8520
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19 Pandemic, SARS-COV-2, COVID-19 Virus Disease, Pediatric patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Dec 2023 (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.
Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. These are caused by a previously unknown coronavirus, initially named 2019-nCoV then SARS-CoV-2, which was identified on January 7, 2020 in the Bronchoalveolar Lavage (BAL) of patients hospitalized in China. As for the first European cases, they were diagnosed in France on January 24, 2020.
A Chinese study published in April 2020 (4) concerning adult patients showed that 14% of these cases could be defined as severe and that 5% of cases could be defined as critical.
Another Chinese study showed that all children, regardless of age, could be infected and that asymptomatic, mild and moderate cases accounted for more than 90% of cases.
In France, the Covid-19 epidemic hit Alsace hard from March 2020, mainly due to the cluster formed by the evangelical assembly of the Christian Open Door Church taking place from February 17 to 21 in Mulhouse in the Haut-Rhin.
Thus, it is interesting to study pediatric patients hospitalized for Covid-19 in Alsace during 2020 in order to discover the clinical characteristics of these patients.
Detailed description
The main objective of this study is to retrospectively describe the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021, both in conventional service and in continuing care or intensive care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subject aged from 1 month to 18 years , hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021.
Key inclusion criteria (4 listed)
- Subject aged from 1 month to 18 years
- Hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021
- Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research
- Parental authority having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.
Key exclusion criteria (1 listed)
- Subject or their parental authority having expressed their opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021
Time frame: Files analysed retrospectively from period from January 1, 2020 to December 31, 2021 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
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 COVID-19 Pandemic, run by University Hospital, Strasbourg, France 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence WEISS, MD (33 3 88 12 83 95, laurence.weiss@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021 (time frame: Files analysed retrospectively from period from January 1, 2020 to December 31, 2021 will be examined). 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 13 Dec 2023.