Recovery After Critical Covid-19 Infection

University of Helsinki250 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

250

Conditions

Covid-19

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Helsinki University Hospital

Helsinki, Capital Province of Finland, Finland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 months after hospital discharge

Cerebral microbleeds

Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain

Time frame: 6 months after hospital discharge

Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge

Data from ClinicalTrials.gov

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Secondary Outcomes

Correlation ApoE 4 alleles with disease severity

Laboratory analysis of ApoE alleles and comparison of their frequencies among groups

Time frame: 6 months post-covid

Correlation of cerebral microbleeds with neuropsychological global score

Correlation of type and location 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

Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging

Time frame: 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

Time frame: 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

Time frame: 6 months after hospital discharge