Status:
COMPLETED
COVID-19 Neurological Disease: A Prospective Study
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Christian Medical College, Vellore, India
Instituto Autoimune, Brazil
Conditions:
Diseases of the Nervous System
Other Specified Viral Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood. Aim: To describ...
Eligibility Criteria
Inclusion
- Cases
- Inclusion criteria:
- Confirmed or probable new-onset acute neurological disease (according to study definitions) AND
- Confirmed or probable COVID-19 (according to study definitions), diagnosed using tests performed no later than 5 days after presentation with neurological disease
- Exclusion criteria (any of):
- Age \<18 years
- Neurological features are explained fully by a previous neurological disease
- PCR test performed \>5 days after admission to hospital, in the absence of clinical illness meeting criteria for suspected COVID-19 (to exclude those with hospital-acquired infection).
- Enrolled on the basis of new-onset acute neurological disease, but subsequently does not meet definition for probable or confirmed COVID-19.
- Controls
- Two controls with non-neurological COVID-19 will be recruited per case.
- They will meet all of the following criteria:
- Adults, no more than 5 years younger or older than the case.
- Enrolled at a similar time since admission to hospital as the case, defined as: \<7 days; 7-13 days inclusive; or ≥14 days.
- Hospitalised patients with confirmed or probable COVID-19 (according to study definitions)
- Not meeting criteria for confirmed or probable new-onset acute neurological disease (according to study definitions).
- Some potential controls may be reclassified as cases if they develop neurological manifestations at up to 30 days after admission to hospital.
Exclusion
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
1017 Patients enrolled
Trial Details
Trial ID
NCT04672590
Start Date
April 20 2021
End Date
December 31 2024
Last Update
April 22 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
FioCruz
Recife, Brazil
2
National Institute of Mental Health and Neurosciences
Bangalore, India
3
Christian Medical College
Vellore, India
4
Malawi Liverpool Wellcome Clinical Research Programme
Blantyre, Malawi, PO Box 30096