TL;DR
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A retrospective study of 230 adults treated at Stanford’s Long COVID Clinic found that reported symptom burden declined and functional scores improved after patients received low-dose naltrexone. Because the study had no control group, it cannot show that the drug caused the changes; randomized trials are needed to test its safety and effectiveness for long COVID.
A retrospective study of 230 adults treated at Stanford’s Long COVID Clinic found that patients reported fewer symptoms and better functioning after receiving low-dose naltrexone off-label. The findings, presented at the IDWeek annual meeting, show an association rather than proof that the drug caused improvement: the study had no comparison group.
Researchers reviewed electronic health records for adults who had laboratory-confirmed COVID-19 and persistent symptoms at least 90 days after infection. Patients needed a clinic visit before starting naltrexone and at least one follow-up visit while taking it. The records spanned 2023 through December 2025. The median final dose was 4 milligrams, below the drug’s approved dosage range.
After adjustment for other factors, the average seven-symptom composite score fell by an estimated 5.1 points per year from a baseline average of 20 (95% confidence interval, −7.69 to −2.52; P<0.001). The number of symptoms also declined, by an estimated 2.4 per year (95% CI, −3.94 to −0.94; P=0.001). Functional stage scores improved by an adjusted mean of 0.32 points per year on a 1-to-5 scale (95% CI, −0.57 to −0.07; P=0.011).
Reported improvements included fatigue, brain fog, unrefreshing sleep, difficulty sleeping and post-exertional malaise. The study did not find significant improvement in headache or lightheadedness. These are changes reported among patients during follow-up, not evidence that every patient improved or that the medication was responsible.
What the Findings Could Mean for Care
The results add observational evidence about a medication some clinicians prescribe off-label to people with long COVID, a condition for which there are no FDA-approved therapies. The reported changes across several symptoms and functional status may help identify a treatment approach for testing in controlled studies. For patients whose symptoms interfere with work and daily activities, the possibility of symptom relief is relevant, but this study cannot establish whether naltrexone offers benefit beyond usual care or the condition’s natural course.
The distinction matters because a before-and-after change does not isolate the effect of a drug. Symptoms may fluctuate, patients may receive other care, and people who return for follow-up may differ from those who do not. The findings should not be treated as a clinical recommendation or as confirmation that low-dose naltrexone works for long COVID. They support further research, not a settled treatment conclusion.
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How the Stanford Review Was Conducted
Naltrexone is an opioid antagonist approved by the U.S. Food and Drug Administration for opioid use disorder and alcohol use disorder; combined with bupropion, it is also used for obesity. Lower doses are prescribed off-label for conditions including multiple sclerosis, fibromyalgia, Crohn’s disease and pain management. The study’s presenter, Brandon Aflak, said naltrexone may have anti-inflammatory and immunomodulatory effects that could be relevant to long COVID. That is a proposed rationale, not a mechanism established by this study.
The participants had a median age of 45.4 years, and 67% were female. Most were fully vaccinated (85.2%), and 70.9% had been infected with an Omicron variant. The median interval from infection to starting naltrexone was 606 days. At the initial assessment, patients reported a median of 12 symptoms. More than half said long COVID reduced their daily activity; 24.3% reported difficulty with normal daily activities, and 8.3% were described as incapacitated and bedridden.
Long COVID definitions vary. The National Academies of Sciences, Engineering, and Medicine defines it as an infection-associated chronic condition following SARS-CoV-2 infection that lasts at least three months and may be continuous, relapsing and remitting, or progressive, affecting one or more organ systems. The report cited a 2022 survey in which 6.9% of U.S. adults said they had ever had long COVID and 3.4% reported having it that year.
What the Study Cannot Establish
The main limitation is the absence of a control group. Without patients receiving placebo or another comparison treatment, researchers cannot tell how much of the improvement, if any, came from naltrexone rather than natural changes in long COVID, other treatments or differences in follow-up. The retrospective design also relies on existing clinical records, rather than a trial that assigns treatment and measures outcomes under a common protocol.
The report does not establish the medication’s safety or effectiveness for long COVID, the size of any benefit compared with placebo, or which patients might benefit. The study included people seen at one specialty clinic, so it may not represent all people with the condition. The presented results also do not show whether improvements lasted after follow-up or whether patients experienced adverse effects. Those points require further research.
The Need for Controlled Trials
Aflak called for randomized, placebo-controlled trials to test low-dose naltrexone for long COVID, including its safety, effectiveness and possible role in care. Such studies could compare changes in symptoms and daily functioning between people assigned to the medication and those assigned to placebo, while tracking dose, duration and adverse effects. The source report does not identify a trial start date or a next scheduled milestone.
Until controlled results are available, the Stanford review remains an observational finding presented at a medical meeting. People considering naltrexone should discuss it with a qualified clinician, who can review their medical history, current medicines and the fact that use for long COVID is off-label.
Key Questions
Did the study prove low-dose naltrexone treats long COVID?
No. It found that reported symptoms and functioning improved over time among patients prescribed the drug, but the retrospective study had no control group and cannot establish that naltrexone caused the changes.
Which symptoms improved in the study?
The study reported improvements in fatigue, brain fog, unrefreshing sleep, difficulty sleeping and post-exertional malaise. It did not find significant improvements in headache or lightheadedness.
What dose did patients take?
The patients’ median final dose was 4 milligrams. Naltrexone is approved for other uses at higher doses; its use for long COVID is off-label, and the study does not establish an appropriate dose for that condition.
What evidence is needed next?
Randomized, placebo-controlled trials are needed to determine whether low-dose naltrexone is safe and effective for long COVID and whether it has a role in clinical care.
Source: rss
