With new flurry of clinical trials, NIH finally seeks treatments for Long Covid

The National Institutes of Health (NIH) yesterday announced new clinical trials to test a diverse array of treatment strategies—from an intravenous immune drug to light therapy and a dietary supplement—in people with Long Covid, the disabling syndrome that can follow infection with the pandemic coronavirus. The focus is on mitigating some of the most common and debilitating symptoms including brain fog and sleep troubles.

Most of the trials will include 100 to 300 people with Long Covid and will start to enroll this year, officials said. One, a multiweek study of the antiviral Paxlovid, has started to sign up participants—it was announced last year but subsequently reduced in size and redesigned to give people a longer course of the drug.

The trials are part of NIH’s RECOVER initiative, which received more than $1 billion in funding from Congress in December 2020 and launched in early 2021. Since then, it has frequently drawn criticism for moving too slowly and not helping Long Covid patients in desperate need of effective care. RECOVER initially focused on defining the postinfection syndrome in part to help quantify the problem and identify risk factors, though RECOVER’s leaders acknowledged yesterday at a press briefing that they still can’t say how many people are affected in the United States

Although patient advocates and researchers expressed relief at the long-awaited list of trials, they also lamented some of the interventions slated for study. “We ask why the NIH is wasting $ studying computer games to treat brain fog, rather than treatments aimed at the underlying pathology of brain fog,” tweeted Dysautonomia International, which advocates for research into disorders of the autonomic nervous system, the peripheral nerves that control blood pressure, heart rate, and other involuntary functions of the human body. Few of the proposed therapies directly address suspected drivers of the syndrome, which has been tentatively linked to certain immune abnormalities, blood clotting, and a persistence of SARS-CoV-2 virus in some tissues.

Among the RECOVER trials are efforts to target neurologic symptoms with a web-based brain training program and a device for transcranial stimulation; treatments for autonomic dysfunction including immune globulin, a mix of antibodies given intravenously to bolster immunity, and a drug called ivabradine, which can lower heart rate; and melatonin, light therapy, and a stimulant for abnormal sleep patterns.

NIH also announced an overhaul of a larger trial testing the antiviral Paxlovid. One popular theory is that people with Long Covid have lingering virus in their bodies, and clearing it may help them. That study was first described last year, with a plan to enroll 1700 people evenly divided between Paxlovid and placebo for 15 days. The trial will now include 900 people, with one arm of the study getting Paxlovid for 25 days. “We were able to get some good feedback” from the U.S. Food and Drug Administration “and others to beef up the design,” said trial leader Kanecia Zimmerman of Duke University at the press conference.

“I’m glad to learn that one arm of the Paxlovid trial will now include 300 patients on the drug for 25 days,” says Amy Proal, a microbiologist at the PolyBio Research Foundation and co-leader of the LongCovid Research Consortium, which has been trying to jump-start research into the syndrome. She notes that some data suggest extended courses of antivirals, and possibly drugs that target immune dysfunction, may be needed to ease symptoms.

NIH officials, who also yesterday announced the launch of the Office of Long Covid Research and Practice, with funding for two staff members, said its other treatment trials should be open to patients within 3 months. Many advocates are now impatiently waiting to see whether the studies bear fruit. “We welcome the NIH’s efforts to finally fund much needed and long overdue trials,” The Long Covid Alliance said in a statement. But any results are likely at least a year off, the alliance predicted. “By then,” the group continued, “Long COVID will have been with us for over four years, an unacceptable wait for patients to see meaningful results from this billion dollar investment.”

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