Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864938
Status:
UNKNOWN
Last Update Posted:
2021-04-29
First Post:
2021-02-09
Brief Title:
Recovery After Critical Covid-19 Infection
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
Recovery After Critical Covid-19 Infection
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVID
Brief Summary:
The study focuses on the recovery of respiratory cardiovascular and neurologicalneuropsychological 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None