The US National Institutes of Health (NIH) has announced the launch of mid-stage clinical trials to test at least four treatments in patients who have symptoms of long COVID, with additional studies expected in the coming months.
The trials are set to evaluate the safety and effectiveness of drugs, biologics, medical devices and multiple therapies simultaneously.
Long COVID is a complex medical condition that has over 200 symptoms that can last for several months or even years after contracting COVID-19, including exhaustion, cognitive impairment, pain, fever and heart palpitations.
One study, RECOVER-VITAL, will test a longer dosing regimen of Pfizer’s antiviral COVID-19 drug Paxlovid (nirmatrelvir and ritonavir) to see if it improves long COVID symptoms.
Another, RECOVER-NEURO, will evaluate accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving.
Rachel Levine, assistant secretary for health at the Department of Health and Human Services, said: “Clinical trials to test effective treatments and interventions are a core component of the whole-of-government response to long COVID.
“Coupled with adequate supports and services, access to clinical care and up-to-date information on what we know about long COVID, we can work toward relief for individuals and families impacted most.”
Part of the NIH’s Researching COVID to Enhance Recovery (RECOVER) initiative, the clinical trials were informed by findings from other RECOVER research from the past two years and focus on ‘burdensome’ symptoms in patients experiencing long COVID.
RECOVER, a large, nationwide research programme designed to understand, treat and prevent long COVID, has positioned the NIH to design and conduct trials that have the potential to provide patients who experience varying symptoms with relief sooner.
The initial stage of the initiative involved launching large, observational, studies examining and following people through their experience with COVID-19 to discover why some people develop long-term symptoms while others recover completely. These studies are ongoing and have recruited more than 24,000 participants to date.
Walter Koroshetz, director of the NIH’s national institute of neurological disorders and stroke, and co-lead of the RECOVER initiative, said: “We’ve taken the lessons learned from RECOVER participants to design rigorous clinical trial platforms that will identify treatments for persons with different symptom clusters to improve their function and well-being.”