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Recovery After Critical Covid-19 Infection (RECOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04864938
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
Uppsala University
Göteborg University
Information provided by (Responsible Party):
Johanna Hastbacka, University of Helsinki

Study Description
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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.

Condition or disease
Covid-19

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
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Recovery After Critical Covid-19 Infection
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 25, 2024
Estimated Study Completion Date : July 25, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Cerebral microbleeds [ Time Frame: 6 months after hospital discharge ]
    Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain

  7. 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

  8. 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


Secondary Outcome Measures :
  1. Correlation ApoE 4 alleles with disease severity [ Time Frame: 6 months post-covid ]
    Laboratory analysis of ApoE alleles and comparison of their frequencies among groups

  2. Correlation of cerebral microbleeds with neuropsychological global score [ Time Frame: 6 moths after hospital discharge ]
    Correlation of type and location of cerebral microbleeds with neuropsychological global score

  3. Association of the incidence of cerebral microbleeds with findings in cardiac MRI [ Time Frame: 6-12 months after hospital discharge ]
    Association of the incidence of cerebral microbleeds with findings in cardiac MRI

  4. Correlation of plasma neurofilament with cerebral microbleeds [ Time Frame: 6 months after hospital discharge ]
    Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging

  5. Correlation of 6 minute walk test heart rate variables with cardiac function [ Time Frame: 6-12 months after hospital discharge ]
    Correlation of heart rate in rest, exercise and 5 minutes after exercise with cardiac output measured in heart MRI

  6. Correlation of matrix metalloproteinase 9 with diffusion capacity [ Time Frame: 6 months after hospital discharge ]
    Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score


Biospecimen Retention:   Samples With DNA
After separate informed consent whole blood specimens have been collected for ApoE allele analysis

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864938


Locations
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Finland
Helsinki University Hospital
Helsinki, Capital Province Of Finland, Finland, 00290
Sponsors and Collaborators
University of Helsinki
Uppsala University
Göteborg University
More Information
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Responsible Party: Johanna Hastbacka, Adjunct professor, University of Helsinki
ClinicalTrials.gov Identifier: NCT04864938    
Other Study ID Numbers: HUS/1949/2020
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johanna Hastbacka, University of Helsinki:
intensive care unit
cognitive function
delirium
post-traumatic stress
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases