Covid19COMEBACNCT04704388
Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 478 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: Paitent admitted between March 1 and May 10, 2020 in Bicêtre hospital for an infection with SARS-CoV-2
Who may be able to join
- -
- Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2
- Major
- Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
- proven SARS-CoV-2 infection
- Treated by invasive mechanical ventilation or high flow humidified oxygen with FiO2 ≥50% for more than 48 hours.
Show all 9Show fewer
- Group 2: patients hospitalized outside intensive care units
- Major
- Admitted between March 1 and May 10, 2020 in an area of Bicêtre hospital having cared for patients infected with SARS-CoV-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology.
Who cannot join
- Patients having refused the post consultation at 3 month
- Without social security coverage
Trial locations and contacts
1 site in 1 country.
About this study
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients hospitalized in intensive care units for SARS-CoV-2 | patients hospitalized in intensive care units for SARS-CoV-2 | |
| patients hospitalized outside intensive care units | patients hospitalized outside intensive care units |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-intensive care syndrome (PICS)
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia.
Measured: 3 month after hospitalisation
Secondary outcomes (3)
Evaluate the 3-month mortality of patients released alive from intensive care
Number of patient deceased
Measured: 3 month after end of hospitalisation
Describe the overall state of health and the main organ sequelae of these patients
Description of the data collected
Measured: 3 month after hospitalisation
functional respiratory sequelae
Compare the functional respiratory sequelae of these patients to those who were hospitalized outside of critical care for COVID-19 pneumonia requiring lower oxygen support.
Measured: 3 month after hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jun 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tài PHAM, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704388
- Sponsor's protocol ID
- COMEBAC
- Acronym
- COMEBAC
- Status last verified
- Mar 2021
- First submitted
- 7 Jan 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pham T, Morin L, Savale L, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Abdo A, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Gosset E, Hardy-Leger I, Quinque M, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four- and sixteen-month clinical status of a cohort of patients following hospitalization for COVID-19. Respir Med Res. 2024 Nov;86:101099. doi: 10.1016/j.resmer.2024.101099. Epub 2024 Mar 4.
PubMed 38843604
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care
- ClinicalTrials.gov ID
- NCT04704388
- Acronym / sponsor ID
- COMEBAC / COMEBAC
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 11 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.
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients hospitalized in intensive care units for SARS-CoV-2 | – | –patients hospitalized in intensive care units for SARS-CoV-2 |
| patients hospitalized outside intensive care units | – | –patients hospitalized outside intensive care units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitent admitted between March 1 and May 10, 2020 in Bicêtre hospital for an infection with SARS-CoV-2
Key inclusion criteria (9 listed)
- -
- Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2
- Major
- Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
- proven SARS-CoV-2 infection
Key exclusion criteria (2 listed)
- Patients having refused the post consultation at 3 month
- Without social security coverage
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
post-intensive care syndrome (PICS)
Time frame: 3 month after hospitalisation
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia.
3 secondary outcomes
Evaluate the 3-month mortality of patients released alive from intensive care
Time frame: 3 month after end of hospitalisation
Describe the overall state of health and the main organ sequelae of these patients
Time frame: 3 month after hospitalisation
functional respiratory sequelae
Time frame: 3 month after hospitalisation
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 1 Apr 2021.
- Derived from this study: PubMed 38843604Pham T, Morin L, Savale L, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Abdo A, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Gosset E, Hardy-Leger I, Quinque M, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four- and sixteen-month clinical status of a cohort of patients following hospitalization for COVID-19. Respir Med Res. 2024 Nov;86:101099. doi: 10.1016/j.resmer.2024.101099. Epub 2024 Mar 4.
- Individual participant dataSharing planned: No
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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.
Tài PHAM principal investigator
APHP
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 Covid19, run by Assistance Publique - Hôpitaux de Paris 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 9 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 1 Apr 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?
post-intensive care syndrome (PICS) (time frame: 3 month after hospitalisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704388, which also lists 1 linked publication.
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 1 Apr 2021.