NIH announces first clinical trials for long-COVID treatments

The National Institutes of Health (NIH) said Monday it will begin enrolling patients in long-delayed clinical trials to test at least four potential treatments for long COVID, adding it expects additional clinical trials to test at least seven more treatments in the coming months.

These are the first clinical studies into a possible treatment for long COVID after Congress in December 2020 provided $1.15 billion in funding over four years for NIH’s RECOVER initiative to support research into the prolonged health consequences of SARS-CoV-2 infection.

Research funded by that allocation has so far been only observational.

In addition to the clinical trials, the Department of Health and Human Services said Monday it has established an Office of Long Covid Research and Practice to lead and coordinate the administration’s response to the condition.

There is no standard definition for long COVID but there are more than 200 symptoms associated with the condition. While most people generally recover from a COVID-19 infection, for some the virus can linger and cause debilitating problems throughout the body.

According to NIH, the trials are designed to evaluate multiple treatments simultaneously to identify more swiftly those that are effective. The initial trials will focus on viral persistence and cognitive dysfunction, like brain fog and memory loss.

The only trial currently underway seeks to test whether a longer dose of Pfizer’s antiviral Paxlovid will help alleviate symptoms of viral persistence, which could occur if the virus stays in the body and causes the immune system to not function properly or causes damage to the organs.

A trial to address symptoms of brain fog will include testing web-based brain training software developed by Posit Science Corporation in San Francisco as well as a web-based goal management training program developed by Mount Sinai Health System. It will further test a device used for home-based transcranial direct current stimulation, developed by Soterix Medical.

The other trials will launch in the coming months and will test treatments to address excessive sleepiness and sleep disturbances, as well as therapies for problems involving the autonomic nervous system, which includes heart rate, breathing and the digestive system.

A fifth platform protocol, focusing on exercise intolerance and fatigue, is under development with input from the patient community and scientific experts, NIH said.