Coronavirus InfectionsCOVID-ReimsNCT04553575
CoViD-19 Patient in Reims University Hospital in March to April 2020
An observational study of Coronavirus Infections, run by CHU de Reims at 1 site in France.
Trial summary
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- serology
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2020to 4 Aug 2022
- How long will I take part?
- 2 Years
- 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: Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
Who may be able to join
- Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
- Age > 18 years
- Patient who benefit from the national health insurance coverage
- patient agree for participation (consent form signed)
Who cannot join
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.
Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)
Read more
Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.
Material and methods:
Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022
Expected results: Better knowledge of the cares of patients with CoViD-19
- Conditions
- Coronavirus Infections
- Being tested
- serology
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serologyBiological
biological blood samples withdrawn at 6, 12 and 24 months
| Study group | Role | What they receive |
|---|---|---|
| CoViD-19 patients cohort | Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies Receives: Biological: serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status in the 2 years after CoViD-19 diagnosis
status : dead or alive persistante respiratory distress (yes / no)
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start25 Sep 2020
- Primary completion24 May 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 127 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553575
- Sponsor's protocol ID
- PO20124*
- Acronym
- COVID-Reims
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2020
- Last updated
- 8 Aug 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020
- ClinicalTrials.gov ID
- NCT04553575
- Acronym / sponsor ID
- COVID-Reims / PO20124*
- Conditions
- Coronavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 17 Sep 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.
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.
Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)
Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.
Material and methods:
Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022
Expected results: Better knowledge of the cares of patients with CoViD-19
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoViD-19 patients cohort | – | Biological: serologyPatients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
Key inclusion criteria (4 listed)
- Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
- Age > 18 years
- Patient who benefit from the national health insurance coverage
- patient agree for participation (consent form signed)
Key exclusion criteria (1 listed)
- Patient protected by law
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 |
|---|---|---|
| serologybiological blood samples withdrawn at 6, 12 and 24 months | Biological | CoViD-19 patients cohort |
Primary outcome
Health status in the 2 years after CoViD-19 diagnosis
Time frame: 2 years follow up
status : dead or alive persistante respiratory distress (yes / no)
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 8 Aug 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.
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 Coronavirus Infections, run by CHU de Reims 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: finished, as of the sponsor's last update on 8 Aug 2022. 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?
Health status in the 2 years after CoViD-19 diagnosis (time frame: 2 years follow up). 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 8 Aug 2022.