October 2022 • PharmaTimes Magazine • 7
// RESEARCH //
The World Health Organization (WHO) has called on countries to take post-COVID-19 condition seriously by urgently investing in research, recovery and rehabilitation.
New modelling conducted for WHO by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington’s School of Medicine in the US, shows that in the first two years of the pandemic, at least 17 million individuals across the 53 Member States of the WHO European Region may have experienced post-COVID-19 condition, also known as long COVID.
Put another way, an estimated 17 million people met the WHO criteria of a new case of long COVID with symptom duration of at least three months in 2020 and 2021.
The modelling indicates a 307% increase in new long COVID cases identified between 2020 and 2021, driven by the rapid increase in confirmed COVID-19 cases from late 2020 and throughout 2021.
The modelling also suggests females are twice as likely as males to experience long COVID. Furthermore, the risk increases dramatically among severe COVID-19 cases needing hospitalisation, with one in three females and one in five males likely to develop long COVID.
“While there is much we still need to learn about long COVID, especially how it presents in vaccinated versus unvaccinated populations and how it impacts re-infections, this data highlights the urgent need for more analysis, more investment, more support and more solidarity with those who experience this condition,” said Dr Hans Henri Kluge, WHO’s regional director for Europe.
Post-COVID-19 condition or long COVID refers collectively to the constellation of long-term symptoms that some people experience after they have had COVID-19. While most people who develop COVID-19 fully recover, it is estimated that 10-20% develop a variety of mid- and long-term effects like fatigue, breathlessness and cognitive dysfunction.
Long COVID can also directly and indirectly affect mental health and the condition can also affect an individual’s ability to perform daily activities such as work or household chores.
ONWARD – the medical technology company creating therapies to restore movement, independence and health in people with spinal cord injury – has announced that the Up-LIFT pivotal study evaluating ARC-EX Therapy achieved its primary effectiveness endpoint of improvement in upper extremity strength and function.
ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with movement disabilities.
The Up-LIFT study is a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation to treat upper extremity functional deficits in people with chronic tetraplegia (paralysis of all four limbs).
The study enrolled 65 people at 14 centres across Europe, the US and Canada. Time since injury averaged 5.9 years with an average subject age of around 46 years. The company plans to submit for regulatory approval in both the US and Europe within the next six months.
Participants completed an average of 50 training sessions over a period of four months. A series of comprehensive assessments were performed at baseline and monthly thereafter to detect changes in sensory and motor function of upper extremities that directly translate into improved functional performance in activities of daily living.
Meanwhile, rigorous measures such as pinch and grasp force were used to detect clinically meaningful changes resulting from the combination of ONWARD ARC-EX Therapy with a standard of care rehabilitation. An independent data safety monitoring board adjudicated the safe conduct of the study.
“The Up-LIFT study results represent a turning point in the field of spinal cord injury and paralysis science,” reflected Marco Baptista, chief scientific officer of the Christopher & Dana Reeve Foundation. “Functional recovery once deemed impossible may now be in reach. The Reeve Foundation looks forward to this technology advancing and, we hope, becoming widely available to our community.”