Sars-CoV2COVID-PRONENCT04438941
Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic
An observational study of Sars-CoV2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2020to 20 Jun 2020
- 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
- Adult, Older adult
Study population: Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session
Who may be able to join
None listed.
Who cannot join
- Subject who expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguarding of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil
Strasbourg, 67091
Bob HEGER, MD, 33 3.69.55.04.43, Bob.Heger@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.
In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).
- Conditions
- Sars-CoV2
- Keywords
- Mechanical ventilation, ICU, Covid-19, SARS-CoV-2, ARDS
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the effect of prone position in patients with covid-19 in intensive care
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start25 Mar 2020
- Primary completion20 Jun 2020 (estimated)
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies 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 only
- Time perspective
- Other
- 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
- NCT04438941
- Sponsor's protocol ID
- 7911
- Acronym
- COVID-PRONE
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jun 2020
- 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 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic
- ClinicalTrials.gov ID
- NCT04438941
- Acronym / sponsor ID
- COVID-PRONE / 7911
- Conditions
- Sars-CoV2
- Keywords
- Mechanical ventilation, ICU, Covid-19, SARS-CoV-2, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 19 Jun 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.
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.
In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Subject who expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguarding of justice
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
Analysis of the effect of prone position in patients with covid-19 in intensive care
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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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 Sars-CoV2, 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 0 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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 Bob HEGER, MD (33 3.69.55.04.43, Bob.Heger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the effect of prone position in patients with covid-19 in intensive care (time frame: 1 month). 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 23 Jun 2020.