Drug and Digital Technologies Are Part of NIH’s Long Covid Clinical Trial Plans

If you have long Covid, the National Institutes of Health is trying to find treatments for you. The NIH is launching a set of Phase 2 clinical trials that will evaluate drug, medical device, and digital interventions to address the ongoing effects of Covid-19 infection. By assessing multiple treatments simultaneously, the NIH hopes to more quickly identify the ones that are most effective.

Long Covid is broadly defined as long-term effects that continue or develop after the initial Covid-19 infection, according to the Centers for Disease Control and Prevention. There is no test for long Covid, which is not a single illness. Not everyone infected by Covid-19 develops long Covid, and in those who do, the condition can vary widely. Ongoing symptoms can include fatigue, fever, breathing difficulty, heart palpitations, cognitive difficulty, changes in smell or taste, joint or muscle pain, and diarrhea.

The long Covid clinical trials stem from the NIH’s Researching Covid to Enhance Recovery (RECOVER) initiative, which aims to improve the understanding of how to predict, treat, and prevent the complications that can occur after an acute Covid-19 infection. The NIH says findings from RECOVER informed the design of clinical trials that have the potential to bring patients relief sooner than an individual study can alone.

“We know that when patients are suffering, we can never move fast enough,” acting NIH Director Lawrence Tabak said in a prepared statement. “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 first NIH study, called RECOVER-VITAL, will focus on SARS-CoV-2 persistence, in which the virus remains in the body and leads to immune system dysfunction and organ damage. Pfizer’s Paxlovid is the first treatment this trial will evaluate. While the antiviral drug is currently approved for treating acute cases of mild-to-moderate Covid-19, the study will assess whether the therapy can improve the symptoms of long Covid. Enrollment in this study is underway.

Cognitive dysfunction is the focus of the second clinical trial, called RECOVER-NEURO. This study will assess BrainHQ, a web-based brain training program developed by Posit Science. This software provides users with brain exercises intended to improve cognitive function and brain health. The clinical trial will also assess PASC-Cognitive Recovery, a web-based goal management training program developed by Mount Sinai Health System. The third intervention chosen for this study is a neurostimulation medical device from Soterix Medical. The NIH says this device has demonstrated the ability to help brain activity and blood flow. Sites for RECOVER-NEURO are currently being activated.

Additional clinical trials are planned to assess sleeping problems that follow Covid-19 infection. The NIH said one placebo-controlled study will assess two undisclosed drugs as treatments for hypersomnia, which is excessive daytime sleepiness. A second sleep study will test unspecified interventions to address problems falling or staying asleep.

Yet another clinical trial will assess problems in the autonomic nervous system, which controls heart rate, breathing, and digestion, among other activities. The NIH said the initial trial will focus on interventions for postural orthostatic tachycardia syndrome (POTS), a disorder with symptoms that include irregular heartbeat, dizziness, and fatigue. One arm of the study will evaluate an unnamed treatment used for immune diseases, comparing it to a placebo. The second arm will evaluate an unnamed drug currently used to treat chronic heart failure in people with an elevated heart rate, also compared to a placebo.

The NIH is developing a fifth study protocol focusing on exercise intolerance and fatigue. For all of these long Covid studies, the agency said launch and study enrollment will happen on a rolling basis at clinical research sites throughout the country. In selecting sites, the NIH said one key criterion was a track record for diverse enrollment. Those sites will contact their patients to recruit study participants. Those who want to learn more about these studies can go here.

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