Covid19TRANSCOVNCT04930120
Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units
An observational study of Covid19, run by Ecole des Hautes Etudes en Santé Publique at 1 site in France.
Trial summary
The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Inter ICU long distance patient transfer
- How many people
- 3,060 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 31 Dec 2022
- 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: Severely ill COVID-19 patients
Who may be able to join
- COVID-19 patients diagnosed biologically or by imaging
- Admission in ICU between 03/13/2020 and 04/10/2020
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
EHESP
Rennes, 35043
Olivier Grimaud, Ph.D., M.D., 02 99 02 2834 ext. 33, olivier.grimaud@ehesp.fr
Christophe Fermanian, Ph.D., 02 99 02 24 69 ext. 33, christophe.fermanian@ehesp.fr
About this study
Official title: TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units
The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.
Read the detailed description
In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.
All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.
- Conditions
- Covid19
- Being tested
- Inter ICU long distance patient transfer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter ICU long distance patient transferOther
Individual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance.
| Study group | Role | What they receive |
|---|---|---|
| Transferred group | The transferred group includes all severe COVID patients admitted in a French ICU ward and then transferred between the 03/13/2020 and 04/10/2020 to another ICU located outside the region of the initial ICU stay. Receives: Other: Inter ICU long distance patient transfer | |
| Control group | The control group includes patients selected out of those whose entire ICU care has taken place in one of the hospitals which transferred patients. Up to 4 control patients will be selected for each transferred patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Status alive or dead
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole des Hautes Etudes en Santé Publique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Grimaud, Ecole des Hautes Etudes en Santé Publique
- Investigators
- Olivier Grimaud, Ph.D., M.D., Principal investigator, Ecole des Hautes Etudes en Santé Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930120
- Sponsor's protocol ID
- 20 CO 015 CZ
- Acronym
- TRANSCOV
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units
- ClinicalTrials.gov ID
- NCT04930120
- Acronym / sponsor ID
- TRANSCOV / 20 CO 015 CZ
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- Ecole des Hautes Etudes en Santé PubliqueUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jun 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.
The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.
Detailed description
In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.
All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transferred group | – | Other: Inter ICU long distance patient transferThe transferred group includes all severe COVID patients admitted in a French ICU ward and then transferred between the 03/13/2020 and 04/10/2020 to another ICU located outside the region of the initial ICU stay. |
| Control group | – | –The control group includes patients selected out of those whose entire ICU care has taken place in one of the hospitals which transferred patients. Up to 4 control patients will be selected for each transferred patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severely ill COVID-19 patients
Key inclusion criteria (2 listed)
- COVID-19 patients diagnosed biologically or by imaging
- Admission in ICU between 03/13/2020 and 04/10/2020
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Inter ICU long distance patient transferIndividual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance. | Other | Transferred group |
Primary outcome
Survival
Time frame: 1 year
Status alive or dead
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Olivier Grimaud, Ph.D., M.D. principal investigator
Ecole des Hautes Etudes en Santé Publique
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 Ecole des Hautes Etudes en Santé Publique 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 2 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: status not confirmed, as of the sponsor's last update on 22 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Grimaud, Ph.D., M.D (02 99 02 28 34 ext. 33, olivier.grimaud@ehesp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). 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 22 Jun 2021.