NIH launches clinical trials testing treatments for long COVID symptoms

Key takeaways:

• The NIH is testing four potential long COVID treatments in phase 2 trials.
• The agency expects to launch additional trials testing at least seven more treatments in the coming months.

The NIH announced that it has launched phase 2 clinical trials that will evaluate potential treatments for long COVID conditions as part of its Researching COVID to Enhance Recovery, or RECOVER, initiative.

The clinical trials are testing at least four potential treatments, according to the NIH. The agency said that it expects to launch additional trials in the coming months to evaluate at least seven more treatments, including drugs, medical devices, biologics and other therapies.

“People living with long COVID can experience wide-ranging and debilitating symptoms. They can have trouble working, sleeping, taking care of their families and doing even basic physical activity, among other issues,” Lawrence A. Tabak, DDS, PhD, acting director of the NIH, said in a press conference. “Our goal with the RECOVER initiative is to figure out why and how some people experience these long-lasting symptoms, and to identify treatments that could help.”

The initial stage of RECOVER, launched in 2021, consisted of observational studies to learn why some patients develop various long-term symptoms while others do not.

Tabak said the new trials will focus on treatments for some of the most burdensome long COVID symptoms.

Two of the trials launched today. They are:

• RECOVER-VITAL, which will initially examine treatment aimed at viral persistence by testing a longer dose regimen of Paxlovid (nirmatrelvir/ritonavir; Pfizer) than is currently used for acute COVID-19; and
• RECOVER-NEURO, which will examine potential interventions for long COVID-related cognitive dysfunction such as brain fog or difficulty with problem solving or attention.

The additional trials that are set to be launched over the coming months include:

• RECOVER-SLEEP, which will study interventions for changes in sleep patterns or sleep ability following SARS-CoV-2 infection;
• RECOVER-AUTONOMIC, which will examine interventions targeting symptoms that are linked to issues in the autonomic nervous system; and
• a trial focusing on exercise intolerance and fatigue.

The trials will use an adaptive design known as “platform protocols,” which allows them to “test multiple treatments simultaneously” and “be quickly adapted to evaluate new therapies,” Tabak said.

“They are designed not only to stand on their own but to inform one another,” he said. “While each trial focuses on certain symptom clusters, they also collect data about the impact of the intervention on a broad range of symptoms.”

He noted that these integrated trials can help to inform clinical care for a range of patients with long COVID.

“Our hope is that these treatments will work,” he said. “However, we may learn that some interventions do not provide measurable relief, and this will also inform patient care. Importantly, we can be confident in the conclusions that emerge, because as always, we have taken a scientifically rigorous approach in designing these trials.”

Kanecia Zimmerman, MD, PhD, principal investigator of the RECOVER Clinical Trials Data Coordinating Center at Duke University Medical Center, said the trials’ goals will be to determine the safety and efficacy of treatments as well as pathophysiology.

“Phase two trials are smaller in general,” she said. “They’re usually 100 to 300 participants per intervention, but this allows us to get to our goal of not only evaluating the intervention but understanding on whether or not it works.”

According to the release, the trials will continue to enroll participants on a rolling basis and follow a traditional recruitment strategy. Enrollment will take place at various clinical research locations across the United States.

Reference:

• NIH launches long COVID clinical trials through RECOVER Initiative, opening enrollment. https://www.nih.gov/news-events/news-releases/nih-launches-long-covid-clinical-trials-through-recover-initiative-opening-enrollment. Published July 31, 2023. Accessed July 31, 2023.