Background There is a dearth of information about “brain fog,” characterized by concentration, word-finding, or memory problems, which has been listed in the new World Health Organization provisional classification “U09.9 Post-COVID-19 Condition.” Moreover, the extent to which these symptoms may be associated with neurological, pulmonary, or psychiatric difficulties is unclear. Objective This ongoing cohort study aims to carefully assess neurocognitive function in the context of the neurological, psychiatric, and pulmonary sequelae of SARS-CoV-2 infection among patients with asymptomatic/mild and severe cases of COVID-19 after remission, including actively recruited healthy controls. Methods A total of 150 participants will be included in this pilot study. The cohort will comprise patients who tested positive for SARS-CoV-2 infection with either an asymptomatic course or a mild course defined as no symptoms except for olfactory and taste dysfunction (n=50), patients who tested positive for SARS-CoV-2 infection with a severe disease 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 be performed comprising nuanced aspects of complex attention, including language, executive function, verbal and visual learning, and memory. Psychiatric, personality, social and lifestyle factors, sleep, and fatigue will be evaluated. Brain magnetic resonance imaging, neurological and physical assessment, and pulmonological and lung function examinations (including body plethysmography, diffusion capacity, clinical assessments, and questionnaires) will also be performed. Three visits are planned with comprehensive testing at the baseline and 12-month visits, along with brief neurological and neuropsychological examinations at the 6-month assessment. Blood-based biomarkers of neurodegeneration will be quantified at baseline and 12-month follow-up. Results At the time of submission, the study had begun recruitment through telephone and in-person screenings. The first patient was enrolled in the study at the beginning of April 2021. Interim data analysis of baseline information is expected to be complete by December 2021 and study completion is expected at the end of December 2022. Preliminary group comparisons indicate worse word list learning, short- and long-delayed verbal recall, and verbal recognition in both patient cohorts compared with those of the healthy control group, adjusted for age and sex. Initial volumetric comparisons show smaller grey matter, frontal, and temporal brain volumes in both patient groups compared with those of healthy controls. These results are quite robust but are neither final nor placed in the needed context intended at study completion. Conclusions To the best of our knowledge, this is the first study to include objective and comprehensive longitudinal analyses of neurocognitive sequelae of COVID-19 in an extreme group comparison stratified by disease severity with healthy controls actively recruited during the pandemic. Results from this study will contribute to the nascent literature on the prolonged effects of COVID-19 on neurocognitive performance via our coassessment of neuroradiological, neurological, pulmonary, psychiatric, and lifestyle factors. Trial Registration International Clinical Trials Registry Platform DRKS00023806; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00023806 International Registered Report Identifier (IRRID) DERR1-10.2196/30259
UNSTRUCTURED 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.
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