Infection With Coronavirus SARS-CoV2CAPACoV19NCT04356378
Long Term Physical Functional Limitations in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation
An observational study of Infection With Coronavirus SARS-CoV2, run by CHU de Reims at 1 site in France.
Trial summary
Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection With Coronavirus SARS-CoV2
- What is being tested?
- Data record
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 20 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: SARS-CoV2 infected patients, hospitalized in the acute phase then requiring rehabilitation follow-up.
Who may be able to join
- patient infected with SARS-CoV2
- in-patient hospitalization in the acute phase because SARS-CoV2 infection
- patient requiring rehabilitation after SARS-CoV2 infection acute phase
- patient adult, aged more than 18 years old
- patient accepting to participate in the study
Who cannot join
- patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study
Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations.
Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management.
Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.
Read the detailed description
The aim of this study is to study factors associated with physical functional limitations in daily living in patients SARS-CoV2 infected and hospitalized in the acute phase then requiring rehabilitation.
- Conditions
- Infection With Coronavirus SARS-CoV2
- Being tested
- Data record
- Keywords
- observational study, cohort study, coronavirus infections, respiratory distress syndrome, adult, rehabilitation, physical functional performance, long term care, exercise tolerance, clinical study
- Medical subject headings
- Coronavirus Infections, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| "infection with coronavirus SARS-CoV2" group | "SARS-CoV2 infected patients" group: in-patient in the acute phase then requiring rehabilitation. Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functional limitations
Physical functional limitations evaluated using 'sit to stand' test. The patient, seated in a chair without armrest, his arms crossed over his shoulders, should get up and sit down without help of the upper limbs as many times as possible in one minute.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start2 Jun 2020
- Primary completion20 Aug 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection With Coronavirus SARS-CoV2Studies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356378
- Sponsor's protocol ID
- PO20055
- Acronym
- CAPACoV19
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study
- ClinicalTrials.gov ID
- NCT04356378
- Acronym / sponsor ID
- CAPACoV19 / PO20055
- Conditions
- Infection With Coronavirus SARS-CoV2
- Keywords
- observational study, cohort study, coronavirus infections, respiratory distress syndrome, adult, rehabilitation, physical functional performance, long term care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 22 Apr 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.
Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations.
Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management.
Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.
Detailed description
The aim of this study is to study factors associated with physical functional limitations in daily living in patients SARS-CoV2 infected and hospitalized in the acute phase then requiring rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "infection with coronavirus SARS-CoV2" group | – | Other: Data record"SARS-CoV2 infected patients" group: in-patient in the acute phase then requiring rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SARS-CoV2 infected patients, hospitalized in the acute phase then requiring rehabilitation follow-up.
Key inclusion criteria (5 listed)
- patient infected with SARS-CoV2
- in-patient hospitalization in the acute phase because SARS-CoV2 infection
- patient requiring rehabilitation after SARS-CoV2 infection acute phase
- patient adult, aged more than 18 years old
- patient accepting to participate in the study
Key exclusion criteria (1 listed)
- patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)
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 |
|---|---|---|
| Data recordData record | Other | "infection with coronavirus SARS-CoV2" group |
Primary outcome
Physical functional limitations
Time frame: 12 months
Physical functional limitations evaluated using 'sit to stand' test. The patient, seated in a chair without armrest, his arms crossed over his shoulders, should get up and sit down without help of the upper limbs as many times as possible in one minute.
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 4 Jun 2024.
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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 Infection With Coronavirus SARS-CoV2, run by CHU de Reims 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 5 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: finished, as of the sponsor's last update on 4 Jun 2024. 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?
Physical functional limitations (time frame: 12 months). 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 4 Jun 2024.