Long COVID Clinical Trial Launches Under NIH, Enrollment Open

Enrollment for phase 2 clinical trials to evaluate four potential long COVID treatments is now open under the National Institutes of Health (NIH).

This clinical trial is a part of the NIH's Researching COVID to Enhance Recovery (RECOVER) Initiative, aimed at understanding, treating and ultimately preventing the symptoms experienced by individuals following SARS-CoV-2 infection.

Additional trials to test at least seven more treatments are expected in the next coming months, according to a release from the NIH.

Long COVID, identified by those experiencing symptoms long after the acute phase of the virus, has been quite the challenging puzzle for researchers and medical professionals to understand.

The initial stages of the RECOVER Initiative included large-scale observational studies, which have shared insights as to why some folks are affected by long COVID, while others recover fully.

Compiled in an analysis of electronic health records and extensive research, the studies laid the groundwork for the latest phase of clinical trials. What sets these trials apart is their design that evaluates multiple treatments at the same time.

According to the NIH, researchers intend to identify effective treatments in the phase 2 trials in order to relieve patients sooner.

"We know that when patients are suffering, we can never move fast enough," said Lawrence A. Tabak, Acting NIH Director, in the release. “NIH is committed to a highly coordinated and scientifically rigorous approach to find treatments that will provide relief for the millions of people living with long COVID.”

The phase 2 will focus on viral persistence and cognitive dysfunction

using a dynamic platform protocol that adapts to the evolving nature of the research, the release said.

Two trials of the RECOVER Initiative include RECOVER-VITAL and RECOVER-NEURO.

RECOVER-VITAL tackles viral persistence by testing extended treatment regimens of the antiviral PAXLOVID. Once a presence of the virus is found, researchers aim to alleviate symptoms and prevent long-term damage to organs or cause a disfunction of one’s immunes system. This intervention has been reported to hold promise in transforming the lives of those affected by long COVID.

RECOVER-NEURO focuses on long COVID’s cognitive dysfunction, and its effects such as brain fog, memory impairment, and difficulty concentrating. Interventions like web-based brain training programs and home-based transcranial direct current stimulation devices, offer some hope for restoring cognitive function and enhancing overall well-being.

Additional platform protocols or trials under review are proposed to launch in the coming months, expanding the number of treatment options for long COVID. These protocols focus on sleep disturbances, autonomic nervous system dysfunction, and exercise intolerance and fatigue.

According to the NIH, they are committed to inclusivity in the selection of diverse clinical research sites across the U.S, ensuring a mixed participant pool.

Access to potential treatments is a priority in the response to long COVID, according to Adm. Rachel L. Levine, assistant secretary for Health for the Department of Health and Human Services

She shared that alongside clinical care and updated information about long COVID, effective treatments are crucial to alleviate the suffering of affected individuals and families.

Trials will continue to launch and enroll participants on a rolling basis. Those interested in learning more about RECOVER trials should visit https://trials.recovercovid.org/(link is external).