Covid19NCT04491214
Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)
An observational study of Covid19 and Follow up, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Follow up, Rehabilitation
- What is being tested?
- quality of live assessment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2020to 21 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with severe SARS-Cov-2 hospitalized in intensive care.
Who may be able to join
- Subject male or female ≥ 18 years old
- Patient hospitalized in the anesthesia-resuscitation department of the NHC for COVID-19 from March 1, 2020.
- Patient (or his legal representative) having given his consent for the use of his data for the purposes of this research.
Who cannot join
- Subject not hospitalized in intensive care
- Patient's refusal to participate in the study
- Inability to give informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
- Subject under low protection
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)
Strasbourg, 67117
About this study
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.
Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.
- Conditions
- Covid19, Follow up, Rehabilitation
- Being tested
- quality of live assessment
- Keywords
- SARS-CoV-2, Follow up, Intensive care unit, Cohort
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of live assessmentOther
quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.
What is being measured
The primary outcome is the main question the study is designed to answer.
assess quality of life after severe COVID infection
assess different dimensions of quality of life: physical and mentaland social dimensions
Measured: measured at 3 months after ICU left.
Secondary outcomes (1)
Quality of life and Clinical status
Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions
Measured: measured at 3 and 6 months after ICU left.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start24 Jul 2020
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
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
- NCT04491214
- Sponsor's protocol ID
- 7890
- Status last verified
- Feb 2020
- First submitted
- 20 Jul 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)
- ClinicalTrials.gov ID
- NCT04491214
- Acronym / sponsor ID
- 7890
- Conditions
- Covid19, Follow up, Rehabilitation
- Keywords
- SARS-CoV-2, Follow up, Intensive care unit, Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 29 Jul 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.
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.
Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with severe SARS-Cov-2 hospitalized in intensive care.
Key inclusion criteria (3 listed)
- Subject male or female ≥ 18 years old
- Patient hospitalized in the anesthesia-resuscitation department of the NHC for COVID-19 from March 1, 2020.
- Patient (or his legal representative) having given his consent for the use of his data for the purposes of this research.
Key exclusion criteria (4 listed)
- Subject not hospitalized in intensive care
- Patient's refusal to participate in the study
- Inability to give informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
- Subject under low protection
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 |
|---|---|---|
| quality of live assessmentquality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36. | Other | – |
Primary outcome
assess quality of life after severe COVID infection
Time frame: measured at 3 months after ICU left.
assess different dimensions of quality of life: physical and mentaland social dimensions
1 secondary outcome
Quality of life and Clinical status
Time frame: measured at 3 and 6 months after ICU left.
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 12 Feb 2021.
- Individual participant dataSharing planned: 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Follow up, 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 3 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: finished, as of the sponsor's last update on 12 Feb 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?
assess quality of life after severe COVID infection (time frame: measured at 3 months after ICU left.). 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 12 Feb 2021.