Covid-19NCT04706260
Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at Strasbourg University Hospitals
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2020to 14 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with covid-19 hospitalized at HUS between 06/03/2020 and 05/04/2020.
Who may be able to join
- Male or female aged 18 or over
- Admitted to the NHC emergency room and hospitalized at the Strasbourg University Hospitals (HUS) between 06/03/2020 and 05/04/2020.
- With SARS-CoV-2 RT-PCR on a positive nasopharyngeal sample taken at the SU.
Who cannot join
- Refusal to participate in the study
- Return home from the SU
- Transfer to another establishment
- Patient under the protection of justice
- Patient under guardianship, curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Adult Emergency Department - Strasbourg University Hospitals
Strasbourg, 67091
About this study
Official title: Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at the University Hospitals of Strasbourg : A Retrospective Observational Study
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020.
Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7.
The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.
- Conditions
- Covid-19
- Keywords
- COVID-19, COVID-19 Pandemic, Sars-cov-2, Emergency Department
- Medical subject headings
- COVID-19, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective evaluation of the clinical evolution and becoming of adult patients infected with Covid-19 hospitalized at the University Hospitals of Strasbourg from the Emergency Structure
Measured: Files analysed retrospectily from March 06, 2020 to April 05, 2020 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 posted12 Jan 2021
- Study start14 Apr 2020
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu OBERLIN, MD, Study director, Adult Emergency Department - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706260
- Sponsor's protocol ID
- 7839
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 7 Oct 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at the University Hospitals of Strasbourg : A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04706260
- Acronym / sponsor ID
- 7839
- Conditions
- Covid-19
- Keywords
- COVID-19, COVID-19 Pandemic, Sars-cov-2, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 12 Jan 2021 (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.
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020.
Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7.
The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with covid-19 hospitalized at HUS between 06/03/2020 and 05/04/2020.
Key inclusion criteria (3 listed)
- Male or female aged 18 or over
- Admitted to the NHC emergency room and hospitalized at the Strasbourg University Hospitals (HUS) between 06/03/2020 and 05/04/2020.
- With SARS-CoV-2 RT-PCR on a positive nasopharyngeal sample taken at the SU.
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Return home from the SU
- Transfer to another establishment
- Patient under the protection of justice
- Patient under guardianship, curatorship
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 evaluation of the clinical evolution and becoming of adult patients infected with Covid-19 hospitalized at the University Hospitals of Strasbourg from the Emergency Structure
Time frame: Files analysed retrospectily from March 06, 2020 to April 05, 2020 will be examined]
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 7 Oct 2021.
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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.
Mathieu OBERLIN, MD study director
Adult Emergency Department - Strasbourg University Hospitals
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, 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 3 inclusion and 5 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 7 Oct 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?
Retrospective evaluation of the clinical evolution and becoming of adult patients infected with Covid-19 hospitalized at the University Hospitals of Strasbourg from the Emergency Structure (time frame: Files analysed retrospectily from March 06, 2020 to April 05, 2020 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 7 Oct 2021.