Skip to content

Recovery After Critical Covid-19 Infection

Recovery After Critical Covid-19 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04864938
Acronym
RECOVID
Enrollment
250
Registered
2021-04-29
Start date
2020-08-01
Completion date
2024-07-25
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Keywords

intensive care unit, cognitive function, delirium, post-traumatic stress

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.

Interventions

None listed

Sponsors

Uppsala University
CollaboratorOTHER
Göteborg University
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Plasma neurofilament level and its correlation with global score in neuropsychological test battery6 months after hospital dischargePlasma neurofilament level and its correlation with global score in neuropsychological test battery
Diffusion capacity 6 months after hospital discharge6 months after hospital dischargeDiffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
Incidence of post myocarditis findings in MRI of the heart6-12 months after hospital dischargeIncidence of findings in cardiac MRI indicating previous myocarditis in each group
Six minute walk test distance6 months after hospital dischargeThe distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
Restriction in lung function tests6 months after hospital dischargeRestriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
Cerebral microbleeds6 months after hospital dischargeNumber and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge6 moths after hospital dischargePlasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
Cognitive function 6 months after hospital discharge6 months after hospital dischargeGlobal 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

Secondary

MeasureTime frameDescription
Correlation of cerebral microbleeds with neuropsychological global score6 moths after hospital dischargeCorrelation of type and location of cerebral microbleeds with neuropsychological global score
Association of the incidence of cerebral microbleeds with findings in cardiac MRI6-12 months after hospital dischargeAssociation of the incidence of cerebral microbleeds with findings in cardiac MRI
Correlation of plasma neurofilament with cerebral microbleeds6 months after hospital dischargeCorrelation of plasma neurofilament with cerebral microbleeds in brain MR imaging
Correlation of 6 minute walk test heart rate variables with cardiac function6-12 months after hospital dischargeCorrelation of heart rate in rest, exercise and 5 minutes after exercise with cardiac output measured in heart MRI
Correlation of matrix metalloproteinase 9 with diffusion capacity6 months after hospital dischargeCorrelation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
Correlation ApoE 4 alleles with disease severity6 months post-covidLaboratory analysis of ApoE alleles and comparison of their frequencies among groups

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026