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The COGCOV Study in ICU Patients

Long-term Cognitive Impairment in ICU Patients, Admitted for COVID-19 Pneumonia: a Single Centre, Prospective Cohort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04593069
Acronym
COGCOV
Enrollment
70
Registered
2020-10-19
Start date
2020-10-07
Completion date
2021-01-13
Last updated
2023-04-18

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

Conditions

Covid19, Cognitive Impairment

Brief summary

Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

Detailed description

The investigators will conduct a single centre, prospective cohort study. COVID-19 patients from the Ziekenhuis Oost-Limburg cohort will be contacted by phone 6 months after admission at the ICU. Patients will be asked to participate in a study surrounding long term symptoms of COVID-19. When consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. If the participant is fluent in Dutch, the experimenter will ask permission to visit their home to conduct more testing.

Interventions

6 months after admission to the intensive care unit of Ziekenhuis Oost-Limburg, the patients will be tested on cognitive impairment

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

masking is not applicable for this study

Intervention model description

All patients enrolled in the study will be contacted to answer additional questions regarding cognitive impairment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted to the intensive care unit of Ziekenhuis Oost-Limburg * Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study * The reason of hospitalization was COVID-19 disease

Exclusion criteria

* No willingness to participate, and therefore not having signed the informed consent

Design outcomes

Primary

MeasureTime frameDescription
Neurocognitive impairment measured by RBANS6 months after admission at the intensive care unitthe Repeatable Battery for the Assessment of Neuropsychological Statusis (RBANS) is a neuropsychological test that provides information about 5 domains of cognition (1) immediate and (2) delayed memory, (3) attention, (4) visuospatial construction and (5) language) and provides a total score. It is a test that takes about 30 minutes and consists of twelve tests. These are: (1) List Learning, (2) Story Memory, (3) Figure Copy, (4) Line Orientation, (5) Picture Naming, (6) Semantic Fluency, (7) Digit Span, (8) Coding, (9) List Recall, (10) List Recognition, (11) Story Recall and (12) Figure Recall. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160

Secondary

MeasureTime frameDescription
Neurocognitive impairment measured by TMT6 months after admission at the intensive care unitTrail Making Test (TMT) is a test of executive functioning, visual search speed, scanning, speed of processing and mental flexibility. The total score is the time in seconds spent to complete each part.
Neurocognitive impairment by the short IQCODE6 months after admission at the intensive care unitThe short IQCODE is a 16 question long questionnaire that assesses cognitive impairment in elderly patients. An informant is required to rate a patient's cognitive changes over a 10 year time period. Each question is scored from 1 (much improved over time) to 5 (much worse).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026