Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 7, 2021
Open Peer Review Period: May 7, 2021 - Jul 2, 2021
Date Accepted: Sep 8, 2021
Date Submitted to PubMed: Sep 24, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Longitudinal Neurocognitive and Pulmonological Profile of Long-Covid: the COVIMMUNE-Clin Study Protocol
ABSTRACT
Aim: This ongoing pilot study compares neurocognitive function, neurological, psychiatric and pulmonary sequelae of COVID-19 infection among asymptomatic and severe cases of COVID-19 after remission and include actively recruited healthy controls. Rationale: Systematic, objective study of neurocognitive function in the long-term after initial COVID-19 infection has resolved (> 12 months post symptom onset).
Methods:
A total number of 150 participants will be included in the study. The cohort will comprise patients after mild SARS-CoV-2 positive infection with an asymptomatic course, except for olfactory and taste dysfunction (n = 50), patients after severe SARS-CoV-2 positive infection with a severely affected course (n = 50), and a healthy control group (n = 50) with similar age and sex distribution, based on frequency matching. A comprehensive neuropsychological assessment will comprise nuanced aspects of complex attention, include language, verbal and visual learning and memory and executive function. Further, psychiatric disorders, pertinent personality, social and lifestyle factors, sleep and fatigue will be included. Neurological, neuroradiological and pulmonological assessments will take place on the same study day. Altogether three visits, at baseline, after 6 and after 12 months are planned with comprehensive testing at the baseline and 12-month visit. Blood-based biomarkers of neurodegeneration will be quantified for baseline and 12 month samples. Outlook: To the best of our knowledge this is the first study to include objective and comprehensive longitudinal analysis of neurocognitive sequelae of COVID-19 in the context of neurological, pulmonary, psychiatric and other pertinent contributing or confounding factors.
Citation
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Copyright
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