Almost five years since the pandemic began, there is not a single FDA-approved treatment

An installation of 300 cots in front of the Washington Monument on May 12, 2023, representing the millions of people suffering from long Covid and myalgic encephalomyelitis/chronic fatigue syndrome.Andrew Harnik/AP

By Julia Moore Vogel and Charlie McCone 

Oct. 24, 2024

Moore Vogel is a long Covid patient-researcher at Scripps Research and the Patient Led Research Collaborative (PLRC). Charlie McCone is a long Covid patient advocate, is a member of the PLRC, and has served as a patient representative on the NIH RECOVER clinical trials arm.

Imagine, for a moment, that you wake up one morning with a debilitating illness that won’t let go. Weeks and months pass, but the crushing fatigue, constant headaches, and aching muscles remain. You can’t think straight. Simply showering or doing the dishes leaves you floored for days at a time, and the unpredictable symptoms — shortness of breath, dizziness, a racing heart — ebb and flow without warning. You find your life as you knew it slipping away.

This is life with long Covid: a condition that transforms the familiar rhythms of daily life into a living nightmare and constant battle for energy and clarity. But what happens when the only hope of lessening its severity becomes an issue of equity?

We are two of the more than 400 million people worldwide who have experienced long Covid. While we are both over four years into this illness, there is still not a single FDA-approved treatment for this devastating condition. Given the slow pace of research and development, there is unlikely to be proven treatment for years — possibly decades. 

For people with long Covid, finding some relief today rests in accessing promising medications that are already on the market. One of us, Charlie, received Plavix that was prescribed off-label and has since substantially improved his quality of life. He still remains mostly housebound, but the drug relieved two years of constant agony of not being able to take a normal breath. Blood thinners including Plavix have been shown to reduce long Covid symptoms, possibly because they reduce microclots and hyperactive platelets found in patients. However, many physicians are wary of prescribing them due to bleeding risks. We are not suggesting that Plavix will be right for everyone with long Covid — we share this experience as an example.

But there is a significant downside to this approach: Combing through countless resources and identifying potential treatment options requires money, educational attainment, and health insurance — as well as time, energy, and cognitive capacity, three things that are in short supply when you have long Covid. Even then, you must be able to meet with several physicians to find an informed and willing provider. If any one of these pieces is missing, people with long Covid are likely to be left without adequate care, particularly if they also face the barriers of  racial, ethnic and gender medical bias. This is yet another example of the already glaring health disparities in the U.S. The result is a health care system that continues to fail and harm the millions of people with long Covid, who must experiment on their own to manage their condition. 

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From personal experience, receiving an off-label drug required meeting with dozens of health care providers, including one along the way who said, “99% physicians would never prescribe it” due to concerns about its side effects. It took a total of 18 months to find a willing prescriber, and it was the only drug to alleviate the debilitating symptom of shortness of breath. 

This is just one treatment among an entire portfolio of promising FDA-approved medications that we and others at the Patient Led Research Collaborative are working to collate, which includes well-known medications like low-dose naltrexone. These medications can be prescribed off-label and have provided some relief to people with long Covid. The evidence base for these treatments largely comes from the extensive literature on infection-associated chronic conditions as well as recent long Covid case studies and crowdsourced data through sources like CureID, Long COVID PharmD’s surveys, and support groups such as communities on Reddit.

Out of desperation, patients are using their limited energy to individually repeat the same web searches and reviews of the literature, then attempting to convince their physicians to prescribe treatments. Many physicians are uncomfortable prescribing off-label medications for long Covid even though one in five prescriptions in the U.S. is written for off-label use. The medical and research communities should be bringing treatment options, along with an assessment of their risks and benefits, to the patients. A national registry collecting data on current off-label drug use to treat long Covid could cost-effectively generate urgently needed safety and efficacy data. 

To lessen the burden of long Covid on people with the condition, we need to get more information into the hands of physicians, while giving patients more decision-making authority. For example, there are high-quality guidelines for diagnosing and managing ME/CFS and POTS, at least one of which most people with long Covid have, yet medical gaslighting continues to run rampant and most medical schools do not educate physicians about these conditions.

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Health care systems should also expand access to survey-based prescriptions for drugs that already have strong safety profiles. Multiple companies offer access to prescriptions after brief patient interactions, but they are generally not covered by insurance, are only available in some states, and do not always include sufficient information about risks or support for addressing side effects.

Further, the federal government must create pathways and incentives for drug repurposing with public health benefits.

Finally, all patients must be informed by their health care providers about treatment options and their risks and benefits, as well as adequately supported in cases where side effects occur. 

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Ultimately, finding cures requires many more high-quality clinical trials, and we desperately need “moonshot” funding to get us there. But in the short term there is so much more the health care system could be doing to provide meaningful care: We call upon the Department of Health and Human Services to find ways to approve, pay for, and collect and disseminate information about treatment options for long Covid and other infection-associated chronic conditions. 

We all prefer making decisions based on gold-standard clinical trials, but if we do nothing while we wait for that data to be generated, people with long Covid will continue to experience debilitating symptoms, loss of income, homelessness, and death. Further, in the absence of guidance, people with long Covid will continue to self-manage their condition, investing in costly treatments and unregulated supplements.

With the support of the health care system, they would have much more comprehensive, readily available information on the risks these treatments might pose — including that certain treatments may help only a subset of people who try them. Patients have the right to make well-informed decisions about accessing promising drugs with reasonable safety profiles. 

Without treatment, 400 million people worldwide could suffer indefinitely. “Do no harm” means providing access to treatments — not withholding them. 

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