Recovery After Critical Covid-19 Infection

Covid-19 Clinical Trial

— RECOVID  

Official title:

Recovery After Critical Covid-19 Infection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04864938
• Other study ID #: HUS/1949/2020
• Status: Enrolling by invitation
• Start date: August 1, 2020
• Est. completion date: July 25, 2024

Study information

• Verified date: April 2021
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: July 25, 2024
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Covid-19
• Infection

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Capital Province Of Finland

Sponsors (3)

Lead Sponsor	Collaborator
University of Helsinki	Göteborg University, Uppsala University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cerebral microbleeds	Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain	6 months after hospital discharge
Primary	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
Primary	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	Correlation ApoE 4 alleles with disease severity	Laboratory analysis of ApoE alleles and comparison of their frequencies among groups	6 months post-covid
Secondary	Correlation of cerebral microbleeds with neuropsychological global score	Correlation of type and location of cerebral microbleeds with neuropsychological global score	6 moths after hospital discharge
Secondary	Association of the incidence of cerebral microbleeds with findings in cardiac MRI	Association of the incidence of cerebral microbleeds with findings in cardiac MRI	6-12 months after hospital discharge
Secondary	Correlation of plasma neurofilament with cerebral microbleeds	Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging	6 months after hospital discharge
Secondary	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	6-12 months after hospital discharge
Secondary	Correlation of matrix metalloproteinase 9 with diffusion capacity	Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score	6 months after hospital discharge