Zooming in on Cerebral Abnormalities in Severely Affected COVID-19 Patients

NCT05197296 | Unknown DMC

• 1 other identifier: 79868
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately one year after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission. This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. In addition, neuropsychological tests and an objective smell/taste test will be used to evaluate neuropsychological status and sense of smell/taste. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.

Conditions

COVID-19; Intensive Care Unit

Keywords

Magnetic Resonance Imaging; Intensive Care Unit; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Radiological outcome

  MRI abnormalities, focusing on vascular abnormalities and olfactory tractus (3T MRI), and lymphatics and the brainstem (7T MRI).

  12-24 months post ICU admission

• Neurological outcome

  Residual neurological symptoms (including sense of smell/taste) and functional status.

  12-24 months post ICU admission

• Clinical outcome

  severity of disease scores, (serial) factors of hyper coagulability and inflammation during ICU admission, neurological and cardiovascular (arterial/venous) complications during hospital admission.

  12-24 months post ICU admission

Secondary Outcomes (1)

• Neuropsychological outcome

  12-24 months post ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of adult patients who survived a COVID-19 infection for which ICU hospital admission was necessary during the second/third pandemic wave (October 2020 - ongoing).

You may qualify if:

• Proven COVID-19 infection for which participant was admitted to the ICU for at least 3 days
• Included in the MaastrICCht cohort (a large database of serial measurements collected during ICU stay from patients with COVID-19 admitted to the ICU in the Maastricht University Medical Center+)
• Informed consent is given
• Sufficient command of the Dutch language to follow test instructions and understand the information letter, informed consent, and questionnaires

You may not qualify if:

• Objective cognitive impairments before hospital admission for the COVID-19 infection
• An unexpected incident leading to severe neurological damage after hospital discharge (such as stroke or traumatic brain injury)
• Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker, claustrophobia, pregnancy, and tattoos in the head/neck region)
• Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
• Contra-indications for a gadolinium-based MRI contrast agent (known allergy or insufficient kidney function determined by an eGFR \< 30 mL/min)
• Physical inability to travel to one of the locations (e.g. bedridden patients)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (approximately 20mL in total) will be drawn using heparin, EDTA, serum and citrate tubes to evaluate markers for hypercoagulation and inflammation.

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Marcel JH Ariës, PhD/MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: June 20, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

NL (1)