Covid-19RECOVIDNCT04864938
Recovery After Critical Covid-19 Infection
An observational study of Covid-19, run by University of Helsinki at 1 site in Finland.
Trial summary
The study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. The results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2020to 25 Jul 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are recovering from critical covid-infection and controls that are either patients recovering from a hospital regular ward treated for covid or covid that has not required hospitalisation. Non-covid controls are age and sex-matched persons (matched to ICU treated group of participants) with no covid-19 in history.
Who may be able to join
- Age 18-100
- Positive PCR for Sars-CoV-2 (except non-covid controls, who must be negative)
- Native language Finnish or Swedish
- Informed consent to study to study participation
Who cannot join
- Age under 18
- Pregnant or lactating
- Major neurologic diagnosis (TBI, dementia, stroke, Parkinson´s disease before covid-19)
- Substantially impaired hearing or vision
- Developmental disability.
- No consent to study participation
- Contraindication to MR imaging (such as cardiac pacemaker, allergy to contrast)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital
Helsinki, Capital Province of Finland, 00290
About this study
The study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. The results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls.
Read the detailed description
Eligible patients who have been treated in the intensive care units of Helsinki University Hospital are invited to participate. Controls are recruited from follow-up clinics, and with announcements in media and websites.
The participants receive an invitation to a follow-up clinic where their experiences from the ICU treatment and recovery will be discussed. The investigators will perform neuropsychologic testing (6 months post-discharge), a telephone interview (3 months) and send written questionnaires (3, 6 and 24 months) to the participants. The participants will undergo MRI imaging of the brain and laboratory tests will be taken. The olfactory function will be tested at a follow-up clinic. Data on the patients´ respiratory function from clinical spirometry and diffusion capacity testing 3 and 6 months after discharge are collected. The patients will perform a 6 min walk test.
Data on coagulation laboratory values will be registered from acute phase and 6 months after discharge. The investigators will also analyse ApoE alleles, neurofilament light and NAD-metabolites and study their correlation with neuropsychologic findings and long term symptoms (up to 5 years after hospital discharge).
Participants will also undergo magnetic resonance imaging of the heart at 6-12 months after the hospital discharge, and laboratory samples, a symptom questionnaire and electrocardiogram are collected. Inflammatory parameters and variables associated with regulating inflammation and coagulation will be analysed.
Clinical data from the acute and post-acute phase and demographic data are collected from the patient data management systems.
The target patient number is 75 intensive care treated patients and 50 control persons in each three control group.
- Conditions
- Covid-19
- Keywords
- intensive care unit, cognitive function, delirium, post-traumatic stress
- Medical subject headings
- COVID-19, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients: ICU treated covid-19 patients | Neuropsychologic testing Respiratory function testing, chest x-ray and 6 minute walk test MRI of the brain and heart Laboratory tests Olfactory function tests Neuropsychology questionnaires | |
| Control group 1, covid-19 patients treated in the regular wards | As above, without 6 minute walk test or routine chest x-ray | |
| Control group 2, persons with covid-19 without hospitalization | As above, but without respiratory testing | |
| Control group 3, non-covid controls | As control group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function 6 months after hospital discharge
Global score calculated from three domains: memory, executive functions and attention.Memory: WMS-III Word list delayed recall + WMS-III Logical memory delayed recall + Rey Complex Figure, delayed recall Executive: TMB (time, reversed) + Stroop interference (time, reversed) + FAB score Attention: WAIS-IV Coding + CPT (correct items) + Stroop naming (time, reversed) The global score will be compared with controls and age matched national references
Measured: 6 months after hospital discharge
Diffusion capacity 6 months after hospital discharge
Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
Measured: 6 months after hospital discharge
Incidence of post myocarditis findings in MRI of the heart
Incidence of findings in cardiac MRI indicating previous myocarditis in each group
Measured: 6-12 months after hospital discharge
Six minute walk test distance
The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
Measured: 6 months after hospital discharge
Restriction in lung function tests
Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
Measured: 6 months after hospital discharge
Cerebral microbleeds
Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
Measured: 6 months after hospital discharge
Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
Measured: 6 moths after hospital discharge
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Measured: 6 months after hospital discharge
Secondary outcomes (6)
Correlation ApoE 4 alleles with disease severity
Laboratory analysis of ApoE alleles and comparison of their frequencies among groups
Measured: 6 months post-covid
Correlation of cerebral microbleeds with neuropsychological global score
Correlation of type and location of cerebral microbleeds with neuropsychological global score
Measured: 6 moths after hospital discharge
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
Measured: 6-12 months after hospital discharge
Correlation of plasma neurofilament with cerebral microbleeds
Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging
Measured: 6 months after hospital discharge
Correlation of 6 minute walk test heart rate variables with cardiac function
Correlation of heart rate in rest, exercise and 5 minutes after exercise with cardiac output measured in heart MRI
Measured: 6-12 months after hospital discharge
Correlation of matrix metalloproteinase 9 with diffusion capacity
Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
Measured: 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Aug 2020
- Primary completion25 Jul 2024 (estimated)
- Study completion25 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Göteborg University
- Responsible party
- Principal investigator, Johanna Hastbacka, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864938
- Sponsor's protocol ID
- HUS/1949/2020
- Acronym
- RECOVID
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ollila H, Pihlajamaa J, Martola J, Kuusela L, Blennow K, Zetterberg H, Salmela V, Hokkanen L, Tiainen M, Hastbacka J. Brain magnetic resonance imaging findings six months after critical COVID-19: A prospective cohort study. J Crit Care. 2024 Apr;80:154502. doi: 10.1016/j.jcrc.2023.154502. Epub 2023 Dec 19.
PubMed 38113746Halvorsen P, Hultstrom M, Hastbacka J, Larsson IM, Eklund R, Arnberg FK, Hokkanen L, Frithiof R, Wallin E, Orwelius L, Lipcsey M. Health-related quality of life after surviving intensive care for COVID-19: a prospective multicenter cohort study. Sci Rep. 2023 Oct 21;13(1):18035. doi: 10.1038/s41598-023-45346-2.
PubMed 37865685Ollila H, Pihlaja R, Koskinen S, Tuulio-Henriksson A, Salmela V, Tiainen M, Hokkanen L, Hastbacka J. Long-term cognitive functioning is impaired in ICU-treated COVID-19 patients: a comprehensive controlled neuropsychological study. Crit Care. 2022 Jul 20;26(1):223. doi: 10.1186/s13054-022-04092-z.
PubMed 35858899
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Critical Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04864938
- Acronym / sponsor ID
- RECOVID / HUS/1949/2020
- Conditions
- Covid-19
- Keywords
- intensive care unit, cognitive function, delirium, post-traumatic stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Uppsala University, Göteborg University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 25 Jul 2024 (estimated)
- First posted
- 29 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.
The study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. The results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls.
Detailed description
Eligible patients who have been treated in the intensive care units of Helsinki University Hospital are invited to participate. Controls are recruited from follow-up clinics, and with announcements in media and websites.
The participants receive an invitation to a follow-up clinic where their experiences from the ICU treatment and recovery will be discussed. The investigators will perform neuropsychologic testing (6 months post-discharge), a telephone interview (3 months) and send written questionnaires (3, 6 and 24 months) to the participants. The participants will undergo MRI imaging of the brain and laboratory tests will be taken. The olfactory function will be tested at a follow-up clinic. Data on the patients´ respiratory function from clinical spirometry and diffusion capacity testing 3 and 6 months after discharge are collected. The patients will perform a 6 min walk test.
Data on coagulation laboratory values will be registered from acute phase and 6 months after discharge. The investigators will also analyse ApoE alleles, neurofilament light and NAD-metabolites and study their correlation with neuropsychologic findings and long term symptoms (up to 5 years after hospital discharge).
Participants will also undergo magnetic resonance imaging of the heart at 6-12 months after the hospital discharge, and laboratory samples, a symptom questionnaire and electrocardiogram are collected. Inflammatory parameters and variables associated with regulating inflammation and coagulation will be analysed.
Clinical data from the acute and post-acute phase and demographic data are collected from the patient data management systems.
The target patient number is 75 intensive care treated patients and 50 control persons in each three control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients: ICU treated covid-19 patients | – | –Neuropsychologic testing Respiratory function testing, chest x-ray and 6 minute walk test MRI of the brain and heart Laboratory tests Olfactory function tests Neuropsychology questionnaires |
| Control group 1, covid-19 patients treated in the regular wards | – | –As above, without 6 minute walk test or routine chest x-ray |
| Control group 2, persons with covid-19 without hospitalization | – | –As above, but without respiratory testing |
| Control group 3, non-covid controls | – | –As control group 2 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are recovering from critical covid-infection and controls that are either patients recovering from a hospital regular ward treated for covid or covid that has not required hospitalisation. Non-covid controls are age and sex-matched persons (matched to ICU treated group of participants) with no covid-19 in history.
Key inclusion criteria (4 listed)
- Age 18-100
- Positive PCR for Sars-CoV-2 (except non-covid controls, who must be negative)
- Native language Finnish or Swedish
- Informed consent to study to study participation
Key exclusion criteria (7 listed)
- Age under 18
- Pregnant or lactating
- Major neurologic diagnosis (TBI, dementia, stroke, Parkinson´s disease before covid-19)
- Substantially impaired hearing or vision
- Developmental disability.
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
Cognitive function 6 months after hospital discharge
Time frame: 6 months after hospital discharge
Global score calculated from three domains: memory, executive functions and attention.Memory: WMS-III Word list delayed recall + WMS-III Logical memory delayed recall + Rey Complex Figure, delayed recall Executive: TMB (time, reversed) + Stroop interference (time, reversed) + FAB score Attention: WAIS-IV Coding + CPT (correct items) + Stroop naming (time, reversed) The global score will be compared with controls and age matched national references
Diffusion capacity 6 months after hospital discharge
Time frame: 6 months after hospital discharge
Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
Incidence of post myocarditis findings in MRI of the heart
Time frame: 6-12 months after hospital discharge
Incidence of findings in cardiac MRI indicating previous myocarditis in each group
Six minute walk test distance
Time frame: 6 months after hospital discharge
The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
Restriction in lung function tests
Time frame: 6 months after hospital discharge
Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
Cerebral microbleeds
Time frame: 6 months after hospital discharge
Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
Time frame: 6 moths after hospital discharge
Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Time frame: 6 months after hospital discharge
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
6 secondary outcomes
Correlation ApoE 4 alleles with disease severity
Time frame: 6 months post-covid
Correlation of cerebral microbleeds with neuropsychological global score
Time frame: 6 moths after hospital discharge
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
Time frame: 6-12 months after hospital discharge
Correlation of plasma neurofilament with cerebral microbleeds
Time frame: 6 months after hospital discharge
Correlation of 6 minute walk test heart rate variables with cardiac function
Time frame: 6-12 months after hospital discharge
Correlation of matrix metalloproteinase 9 with diffusion capacity
Time frame: 6 months after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 38113746Ollila H, Pihlajamaa J, Martola J, Kuusela L, Blennow K, Zetterberg H, Salmela V, Hokkanen L, Tiainen M, Hastbacka J. Brain magnetic resonance imaging findings six months after critical COVID-19: A prospective cohort study. J Crit Care. 2024 Apr;80:154502. doi: 10.1016/j.jcrc.2023.154502. Epub 2023 Dec 19.
- Derived from this study: PubMed 37865685Halvorsen P, Hultstrom M, Hastbacka J, Larsson IM, Eklund R, Arnberg FK, Hokkanen L, Frithiof R, Wallin E, Orwelius L, Lipcsey M. Health-related quality of life after surviving intensive care for COVID-19: a prospective multicenter cohort study. Sci Rep. 2023 Oct 21;13(1):18035. doi: 10.1038/s41598-023-45346-2.
- Derived from this study: PubMed 35858899Ollila H, Pihlaja R, Koskinen S, Tuulio-Henriksson A, Salmela V, Tiainen M, Hokkanen L, Hastbacka J. Long-term cognitive functioning is impaired in ICU-treated COVID-19 patients: a comprehensive controlled neuropsychological study. Crit Care. 2022 Jul 20;26(1):223. doi: 10.1186/s13054-022-04092-z.
- 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 Covid-19, run by University of Helsinki at 1 site in Finland.
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 7 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 29 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 Finland. 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?
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?
Cognitive function 6 months after hospital discharge (time frame: 6 months after hospital discharge). The study lists 8 primary outcomes in all. 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 NCT04864938, which also lists 3 linked publications.
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 29 Apr 2021.