Covid19ISISNCT04852718
Rehabilitation Program for the Sequelae of COVID 19 Infection
An observational study of Covid19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
SUBPROJECT 1: Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital. Retrospective observational study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2021to 13 Apr 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 to 80 years
- All sexes
- Adult, Older adult
Study population: • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.
Who may be able to join
- • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.
- PCR or serological negative test or more than 28 days after diagnosis.
- Dyspnoea in activities of daily living (mMRC ≥ 2), (Annex 5 of the clinical protocol).
- Patients who had muscle weakness (Clinical Frailty Scale ≥ 3), (Annex 1 of the clinical protocol).
Who cannot join
- Patients with disease activity.
- Live outside the reference area of the Hospital de la Santa Creu i Sant Pau.
- Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Maria-Rosa Güell-Rous, PhD, 34935565972 ext. 5964, mguellr@santpau.cat
About this study
Official title: Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice
SUBPROJECT 1:
Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital.
Read more
Retrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed.
SUBPROJECT 2:
Evaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life.
Prospective observational study of a single cohort of patients. The data will be collected from successive clinical visits.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular function
Short Physical Performance Battery (SPPB) value 0-12
Measured: 1 year
Secondary outcomes (3)
Health-related Quality of life
SF36 questionnaire, vaule 0-100
Measured: 1 year
Respiratory muscle function
Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP)
Measured: 1 year
Exercise capacity
Six-minute walking Test (6MWT): meters,
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 posted21 Apr 2021
- Study start13 Apr 2021 (estimated)
- Primary completion13 Apr 2021 (estimated)
- Study completion13 Apr 2021 (estimated)
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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria-Rosa Güel-Rous, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852718
- Sponsor's protocol ID
- IIBSP-COV-2020-155
- Acronym
- ISIS
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perrot JC, Segura M, Beranuy M, Gich I, Nadal MJ, Pintor A, Terra J, Ramirez E, Paz LD, Bascunana H, Plaza V, Guell-Rous MR. Comparison of post-COVID symptoms in patients with different severity profiles of the acute disease visited at a rehabilitation unit. PLoS One. 2022 Sep 16;17(9):e0274520. doi: 10.1371/journal.pone.0274520. eCollection 2022.
PubMed 36112577
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice
- ClinicalTrials.gov ID
- NCT04852718
- Acronym / sponsor ID
- ISIS / IIBSP-COV-2020-155
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 13 Apr 2021 (estimated)
- Primary completion
- 13 Apr 2021 (estimated)
- Study completion
- 13 Apr 2021 (estimated)
- First posted
- 21 Apr 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.
SUBPROJECT 1:
Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital.
Retrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed.
SUBPROJECT 2:
Evaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life.
Prospective observational study of a single cohort of patients. The data will be collected from successive clinical visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.
Key inclusion criteria (4 listed)
- • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.
Key exclusion criteria (3 listed)
- Patients with disease activity.
- Live outside the reference area of the Hospital de la Santa Creu i Sant Pau.
- Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.
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
Muscular function
Time frame: 1 year
Short Physical Performance Battery (SPPB) value 0-12
3 secondary outcomes
Health-related Quality of life
Time frame: 1 year
Respiratory muscle function
Time frame: 1 year
Exercise capacity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Derived from this study: PubMed 36112577Perrot JC, Segura M, Beranuy M, Gich I, Nadal MJ, Pintor A, Terra J, Ramirez E, Paz LD, Bascunana H, Plaza V, Guell-Rous MR. Comparison of post-COVID symptoms in patients with different severity profiles of the acute disease visited at a rehabilitation unit. PLoS One. 2022 Sep 16;17(9):e0274520. doi: 10.1371/journal.pone.0274520. eCollection 2022.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Maria-Rosa Güel-Rous, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 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 21 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 Spain. 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 Maria-Rosa Güel-Rous, PhD (34935565972 ext. 5964, mguellr@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular function (time frame: 1 year). 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 NCT04852718, 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 21 Apr 2021.