Covid19REHABCOVNCT04681755
Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection
An observational study of Covid19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2020to 19 May 2021
- 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: Adult patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
Who may be able to join
- Adult patient (≥18 years old)
- Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020.
- Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
- Patient who has given his consent for the use of his data for the purposes of this research
Who cannot join
- Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner)
- Patient who expressed his opposition to participating in the study
- Subject under safeguard of justice
- Subject under guardianship or guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Strasbourg University Hospitals - Anesthesia and surgical resuscitation service
Strasbourg, 67091
Walid Oulehri, MD, 33 3 69 55 12 72, walid.oulehri@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/).
Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.
- Conditions
- Covid19
- Keywords
- Rehabilitation, SARS-CoV-2, COVID-19, Neurological function, Respiratory disorder, Intensive care unit
- Medical subject headings
- COVID-19, Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection
Measured: The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start19 May 2020
- Primary completion19 May 2021 (estimated)
- Study completion19 May 2021 (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.
- 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
- Retrospective
- Enrolment
- 55 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
- NCT04681755
- Sponsor's protocol ID
- 7725
- Acronym
- REHABCOV
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 28 Dec 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 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units
- ClinicalTrials.gov ID
- NCT04681755
- Acronym / sponsor ID
- REHABCOV / 7725
- Conditions
- Covid19
- Keywords
- Rehabilitation, SARS-CoV-2, COVID-19, Neurological function, Respiratory disorder, Intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 19 May 2021 (estimated)
- Study completion
- 19 May 2021 (estimated)
- First posted
- 23 Dec 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.
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/).
Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020.
- Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
- Patient who has given his consent for the use of his data for the purposes of this research
Key exclusion criteria (4 listed)
- Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner)
- Patient who expressed his opposition to participating in the study
- Subject under safeguard of justice
- Subject under guardianship or guardianship
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
Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection
Time frame: The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 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 Covid19, 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 4 inclusion and 4 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 28 Dec 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 Walid Oulehri, MD (33 3 69 55 12 71, walid.oulehri@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection (time frame: The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined]). 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 28 Dec 2020.