COVIDCOVIDGHPSJCiteNCT04365530
Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City
An observational study of COVID, run by Fondation Hôpital Saint-Joseph at 5 sites in France.
Trial summary
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- How many people
- 3,767 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Apr 2020to 6 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patientwith symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
Who may be able to join
- Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
Who cannot join
- Asymptomatic patient
- Patient objecting to the use of their data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
AURA Paris Plaisance
Paris, 75014
Fondation Sainte-Marie
Paris, 75014
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Hôpital Bellan
Paris, 75014
About this study
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.
Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.
In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.
- Conditions
- COVID
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical consequences of a Covid-19 infection in the care population
This outcome measures the clinical consequences of a Covid-19 infection in the care population.
Measured: Year 2
Secondary outcomes (6)
Risk factors at M6
This outcome evaluates the risk factors of COVID-19 at month 6
Measured: Month 6
Risk factors at year 1
This outcome evaluates the risk factors of COVID-19.
Measured: Year 1
Risk factors at year 2
This outcome evaluates the risk factors of COVID-19.
Measured: Year 2
Impact of hospital reorganization on medical care at M6
This outcome evaluates the impact of hospital reorganization on medical care at month 6.
Measured: Month 6
Impact of hospital reorganization on medical care at Year 1
This outcome evaluates the impact of hospital reorganization on medical care at year 1.
Measured: Year 1
Impact of hospital reorganization on medical care at Year 2
This outcome evaluates the impact of hospital reorganization on medical care at year 2.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2022
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 3,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit PILMIS, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365530
- Sponsor's protocol ID
- Cohorte COVID GHPSJ CiteH
- Acronym
- COVIDGHPSJCite
- Status last verified
- Mar 2023
- First submitted
- 26 Apr 2020
- Last updated
- 7 Mar 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City
- ClinicalTrials.gov ID
- NCT04365530
- Acronym / sponsor ID
- COVIDGHPSJCite / Cohorte COVID GHPSJ CiteH
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,767 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 28 Apr 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.
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.
Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.
In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patientwith symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
Key inclusion criteria (1 listed)
- Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
Key exclusion criteria (2 listed)
- Asymptomatic patient
- Patient objecting to the use of their data
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
Clinical consequences of a Covid-19 infection in the care population
Time frame: Year 2
This outcome measures the clinical consequences of a Covid-19 infection in the care population.
6 secondary outcomes
Risk factors at M6
Time frame: Month 6
Risk factors at year 1
Time frame: Year 1
Risk factors at year 2
Time frame: Year 2
Impact of hospital reorganization on medical care at M6
Time frame: Month 6
Impact of hospital reorganization on medical care at Year 1
Time frame: Year 1
Impact of hospital reorganization on medical care at Year 2
Time frame: Year 2
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 Mar 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.
Benoit PILMIS, MD principal investigator
Fondation Hôpital Saint-Joseph
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Fondation Hôpital Saint-Joseph at 5 sites 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 1 inclusion and 2 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Clinical consequences of a Covid-19 infection in the care population (time frame: Year 2). 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 Mar 2023.