Clinical trial NCT04864938: Recovery After Critical Covid-19 Infection
Official title: Recovery After Critical Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: intensive care unit
cognitive function
delirium
post-traumatic stress
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Göteborg University
First posted: 2021-04-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Cognitive function 6 months after hospital discharge
timeFrame: 6 months after hospital discharge
measure: Diffusion capacity 6 months after hospital discharge
timeFrame: 6 months after hospital discharge
measure: Incidence of post myocarditis findings in MRI of the heart
timeFrame: 6-12 months after hospital discharge
measure: Six minute walk test distance
timeFrame: 6 months after hospital discharge
measure: Restriction in lung function tests
timeFrame: 6 months after hospital discharge
measure: Cerebral microbleeds
timeFrame: 6 months after hospital discharge
measure: Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
timeFrame: 6 moths after hospital discharge
measure: Plasma neurofilament level and its correlation with global score in neuropsychological test battery
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: Correlation ApoE 4 alleles with disease severity
timeFrame: 6 months post-covid
measure: Correlation of cerebral microbleeds with neuropsychological global score
timeFrame: 6 moths after hospital discharge
measure: Association of the incidence of cerebral microbleeds with findings in cardiac MRI
timeFrame: 6-12 months after hospital discharge
measure: Correlation of plasma neurofilament with cerebral microbleeds
timeFrame: 6 months after hospital discharge
measure: Correlation of 6 minute walk test heart rate variables with cardiac function
timeFrame: 6-12 months after hospital discharge
measure: Correlation of matrix metalloproteinase 9 with diffusion capacity
timeFrame: 6 months after hospital discharge
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Capital Province Of Finland
Study officials:
References:
citation: Ollila 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.