Recovery After Critical Covid-19 Infection

NCT04864938 | Unknown

• 1 other identifier: HUS/1949/2020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  6 months after hospital discharge

• Cerebral microbleeds

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

  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

  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

  6 months after hospital discharge

Secondary Outcomes (6)

• Correlation ApoE 4 alleles with disease severity

  6 months post-covid

• Correlation of cerebral microbleeds with neuropsychological global score

  6 moths after hospital discharge

• Association of the incidence of cerebral microbleeds with findings in cardiac MRI

  6-12 months after hospital discharge

• Correlation of plasma neurofilament with cerebral microbleeds

  6 months after hospital discharge

• Correlation of 6 minute walk test heart rate variables with cardiac function

  6-12 months after hospital discharge

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Helsinki: lead
• Uppsala University: collaborator
• Göteborg University: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Capital Province of Finland, 00290, Finland

Location

Related Publications (3)

• 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.

  PMID: 38113746 DERIVED

• Halvorsen 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.

  PMID: 37865685 DERIVED

• 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.

  PMID: 35858899 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

After separate informed consent whole blood specimens have been collected for ApoE allele analysis

MeSH Terms

Conditions

COVID-19; Delirium

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: April 29, 2021
• Study Start: August 1, 2020
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

FI (1)