Participation is open to four trials that examine new treatments for COVID, the National Institutes of Health announced during a press conference on Monday. Further clinical trials that determine at least seven other therapies are expected to start in the next few months.
The studies are part of the NIH’s research efforts called The Researching COVID to Enhance Recovery (RECOVER) Initiative. In December of this year, Congress approved $1.15 billion for the NIH to conduct research and evaluate treatment options for COVID that lasts a long time. The clinical trials being conducted now are part of phase II, designed to determine how safe the treatments are and how they function.
Some advocates are worried the process is moving too slowly.
The Long COVID Alliance “is both encouraged and concerned by the announcement today from NIH,” the group stated in an announcement. “We applaud the efforts of NIH to finally provide much-needed and long overdue studies of long-term COVID. … The announcement today however leaves a number of crucial questions unanswered. It also seems to be brimming with the same opacity that is now all too familiar to RECOVER with it’s $1.15 billion spending plan.”
Patients with long COVID have become more discontent with ineffective treatment options. Some doctors have resorted to non-approved use of certain medications to treat COVID.
Walter J. Koroshetz, MD director of NIH National Institute of Neurological Disorders and Stroke and co-director for the RECOVER Initiative, said the agency doesn’t know precisely how many sufferers have COVID. “The answer depends on how you define the issue and what type of variant led to it. The incidence rate was greater within Delta,” he said during the briefing. Some estimates suggest that 5-10 up to 10 percent of people suffering from COVID develop long-term symptoms. “I don’t think we have solid numbers as it’s a moving target,” Koroshetz declared.
Here are the details of the four trials:
- RECOVER-VITAL will focus on the treatment of virus persistence, which could occur when the virus persists and causes the immune system to fail to function correctly. One option is to test an increased dose of Antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID-19 to stop it from transforming into severe COVID.
- RECOVER-NEURO is a targeted treatment for memory issues, brain fog as well as attention problems. Some of the treatments that could be considered are a program dubbed BrainHQ, which is an online-based training, as well as the PASC Cognitive Recovery (post-acute consequences of COVID), an online program created in collaboration with Mount Sinai Health System in New York. The program is also being studied as an actual stimulation program for current to increase the brain’s activity.
- The RECOVER-SLEEP study will examine the treatment options for sleep problems, including insomnia during the day and other issues. According to Koroshetz, some options are being investigated for Melatonin, light therapy, and the education-based coaching program.
- The RECOVER-AUTONOMIC trial will look at treatments that can alleviate symptoms associated with autonomic nervous system problems. The initial trial will concentrate on POTS disorder (postural orthostatic tachycardia disorder), which may cause an unsteady heartbeat, fatigue, and dizziness. The treatment for immune diseases and a drug currently used for chronic heart problems will also be evaluated.
According to Kanecia Zimmerman, MD, a principal investigator of the Duke Clinical Research Institute, the clinical trials data coordination center for tests, the first viral persistence trial has been launched. “We are actively working to launch the second on cognitive dysfunction.” She explained that the autonomic and sleep practices will start in the coming months. Another test is planned to investigate exercise intolerance, which is a problem that is reported by a lot of people with COVID.
However, the Long COVID Alliance said, yet again, that the NIH’s plan needs to be more apparent.
“The NIH has not presented a timeline for results: They have highlighted that enrollment will begin over the next several months, likely meaning that results to benefit many millions with Long COVID are still at least a year away,” the group stated.
At that point, COVID has been around for over four years, “an unacceptable wait for patients to see meaningful results from this billion-dollar investment.”