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Zooming in on cerebral abnormalities in severely affected COVID-19 patients: a 3T and 7T MRI study

Zooming in on cerebral abnormalities in severely affected COVID-19 patients: a 3T and 7T MRI study - ZoomCOVID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53824
Enrollment
105
Registered
2022-04-19
Start date
2022-06-20
Completion date
Unknown
Last updated
2025-11-10

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

Conditions

corona disease COVID-19 infection

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: COVID-19 ICU survivors: - Proven COVID-19 infection for which they were admitted to 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  het Maastricht University Medical Centre+; METC 2020-1565/3 00 523) - Age >= 18 years - Informed consent - Sufficient command of the Dutch language to follow test instructions and  understand the information letter, informed consent, and questionnaires ICU survivors: - Admission to the intensive care unit at the Maastricht UMC+ for at least 3  days - Reason for ICU admission: severe infection (bacterial, viral, fungal) with  respiratory insufficiency - If tested for COVID-19 on ICU, negative PCR test result; if not tested for  COVID-19 on ICU, no suspicion for COVID-19 positive infection - Age >= 18 years - Informed consent - Sufficient command of the Dutch language to follow test instructions and  understand the information letter, informed consent, and questionnaires

Exclusion criteria

Exclusion criteria: COVID-19 ICU survivors: - Objective cognitive impairments before the 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 - Physical inability to travel to one of the locations (e.g., bedridden  patients) ICU survivors: - Positive COVID-19 PCR test during ICU admission - Objective cognitive impairments before the ICU admission  - 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 - Physical inability to travel to one of the locations (e.g., bedridden  patients).

Design outcomes

Primary

MeasureTime frame
Radiological outcome at 12-24 months follow-up: MRI abnormalities, focussing on vascular abnormalities and olfactory tractus (3T MRI), and glymphatics and the brainstem (7T MRI). Neurological outcome: residual neurological symptoms (including smell/taste) and functional status at follow-up. Clinical outcome: severity of disease scores, (serial) factors of hypercoagulability and inflammation during ICU admission, neurological and cardiovascular (arterial/venous) complications during hospital admission.

Secondary

MeasureTime frame
Neuropsychological outcome: global deficits in cognitive and neurological functioning, objective changes in or loss of smell/taste and residual signs of inflammation and hypercoagulopathy at follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)