The magnitude of the various effects of COVID-19 on the human body is just now being realized, as more and more data become available from cases around the world. Initially thought to infect primarily the respiratory system, causing breathing difficulties with progression to advanced respiratory distress syndrome in the most serious cases, the SARS-CoV-2 virus is proving to be a formidable threat to other systems of the body as well. This includes the cardiovascular system, the renal system, the digestive system and, more recently, the central and peripheral nervous systems.

COVID-19 patients across the globe have experienced loss of taste and smell, headaches and dizziness as milder symptoms of the disease; strokes, seizures and paralysis are occurring in more severe cases, all pointing to disruptions in the nervous system. It is not yet known whether the impact occurs as a direct result of the virus or from the body’s physiological response to it. Furthermore, some of the reported cases of neurological dysfunctions may be coincidental, given the high prevalence of the virus across the globe. To date, there are no definitive studies or results from systematically conducted research to understand the impact of COVID-19 on the nervous system.

The Ohio State University College of Medicine neurologist Shraddha Mainali, MD, along with College of Nursing colleague Molly McNett, PhD, RN, CRN, are working to solve this issue. They are part of an eight-member team of adult and pediatric international experts who quickly came together to develop a plan for studying the impact of COVID-19 on the nervous system, using the global platform in the context of a pandemic.

“We established the Global Consortium to Study Neurological dysfunctions in COVID-19 patients in a systematic manner and promptly launched a research program, utilizing a tiered approach with a pragmatic and feasible design, to enable successful implementation in the midst of a global pandemic,” says Dr. Mainali.

Endorsed by the Neurocritical Care Society (NCS), the study aims to establish research protocols for gathering data and evaluating the knowledge gaps in a systematic manner. This NCS initiative represents one of the largest global research collaboratives to study the neurological manifestation of COVID-19.

“There is still so much we don’t know about this disease, especially as it relates to the neurological system,” says Dr. McNett. “This scientific examination of the evidence will inform our conclusions about causality versus coincidence across diverse settings and populations.”

The team has divided the study into adult and pediatric arms to address the challenge across all age groups. The study is designed to proceed in three tiers. Tier 1 will collect observational data elements from sites established around the globe and assess the outcomes of those cases. Currently, there are more than 100 sites, including 23 countries on five continents registered for this Tier 1 phase of inquiry.

Tier 2 will evaluate the functional and cognitive outcomes with greater details of clinical, laboratory and radiographic data performed as part of the standard of care. Tier 3 overlays tiers 1 and 2 with experimental molecular, electrophysiology, pathology and imaging studies with longitudinal outcomes assessment.

This tiered approach “also allows for adjustment and addition of pertinent new neurological findings in higher tiers, as new neurologic manifestations surface over time,” explains Dr. Mainali.

One of the essential weapons in attacking a pandemic of this magnitude is having access to as much knowledge as possible about the transmission dynamics and clinical manifestations of the disease, while researchers search for an effective vaccine. This NCS study aims to provide that knowledge and share it with members of the research community.

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