Lancet: Where are the long COVID trials?

Sly Saint

Sly Saint

Senior Member (Voting Rights)
The news in early July, 2023, that STOP-PASC, a clinical trial at Stanford University, CA, USA, testing nirmatrelvir-ritonavir in patients with long COVID, is closing enrolment before the full study size has been reached, is disheartening. STOP-PASC is one of the few clinical trials studying a pharmacological intervention for long COVID and although the reason for termination hasn't been confirmed yet, it adds to the dismal state of clinical research relative to the substantial burden of the condition.
ClinicalTrials.gov currently lists 386 trials under the search term Long COVID. However, only 94 of those studies are classed as interventional and are currently recruiting, and even more disturbing, only 12 trials are testing pharmacological interventions. The rest comprise follow-up of trials in acute infection, rehabilitation, food supplements, telehealth, psychological support, physiotherapy, acupuncture, light therapy, Chinese herbal medicine etc. While the list ranges from “nice to have additional support” to questionable alternative cures or even potentially harmful treatments, we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.
There is a desperate need for long COVID treatments. Although estimates vary quite widely between populations and studies and depending on the definitions and methods used, 1 in 10 people experiences long COVID after infection. Lasting symptoms range from mild to disabling, with people unable to work or even bed-bound and unable to take care of basic personal needs. These individual tragedies have wide-ranging repercussions, leading to lost earnings, a shrinking workforce, and increased healthcare and social care costs. Again, estimates vary widely, but the impact is in the range of billions to trillions US dollars globally. Why do we only have 12 pharmacological interventional trials then?

The reasons of course are manifold, including diagnostic uncertainty, lack of validated biomarker (which ideally would be easy to integrate into current clinical practice), multisystem conditions not easily falling into the current system of medical specialties, misogyny and other prejudices against groups particularly affected by long COVID, historical neglect of other postviral conditions such as myalgic encephalomyelitis/chronic fatigue syndrome, a societal and political wish to go ‘back to normal’, limited interest of the pharma industry in repurposing low profit drugs, minimisation of long COVID because of insurance and disability costs and so on.

Last but not least, the mistaken belief that long COVID is a psychogenic condition also hinders progress. Numerous studies have shown pathological changes in patients with long COVID; nevertheless, the first question after a talk on long COVID at a recent medical conference was whether the patients had been assessed for burn out or personality disorders. Would you ask this about people with cancer? Of course this comparison is deliberately exaggerated, but it reflects the reality of many patients with long COVID who face dismissal or even blame by healthcare professionals. On the other hand, even clinicians up-to-date with long COVID and empathetic with their patients, have no treatments proven to be effective in clinical trials to help their patients.
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full text
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00440-1/fulltext?rss=yes
 
Importantly, this is an editorial: it’s the Lancet Infectious Diseases editor speaking ex cathedra, rather than a personal view from a researcher or clinician. The job of an editorial is not to challenge the preconceptions of the readership, but to bolster and refine them. So it’s refreshing and cheering to see this while publications in the BMJ stable are behaving so poorly.
 
Interesting editorial.

When ME/CFS advocates argued that more funding should go to testing non-pharmacological interventions we were always accused of having a reductionist mind, biased against psychotherapy, blocking progress, etc.

And anyone that mentioned that some seem to minimize ME/CFS to reduce insurance and disability costs, was seen as a crackpot conspiracy theorist.
 
There is a desperate need for long COVID treatments
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The reasons of course are manifold, including diagnostic uncertainty, lack of validated biomarker (which ideally would be easy to integrate into current clinical practice), multisystem conditions not easily falling into the current system of medical specialties, misogyny and other prejudices against groups particularly affected by long COVID, historical neglect of other postviral conditions such as myalgic encephalomyelitis/chronic fatigue syndrome,
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Last but not least, the mistaken belief that long COVID is a psychogenic condition also hinders progress
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Good to see this in the Lancet, but it is sorely missing the very significant, and stubbornly continuing, role that the Lancet played in this.

They could radically change this by retracting PACE. A good example of the head and the hands not talking to one another. Still, this is frank.
 
Jonathan Edwards said:
The editor may well be a journalist who happens to be sympathetic to the PWME cause.
The editorial officers do not appear to be medics.
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The editor in chief of LID is Ursula Hofer. Although she has been working in medical publishing for a while, she qualified as a doctor in Berne and practised as a clinical immunologist at University Hospital Zurich while engaged on doctoral infectious diseases research. Brief industry stint, then moved into scientific journals, mainly Nature.

She looks like someone who is eminently well qualified to speak for the infectious diseases community, if not as a senior clinical peer, then certainly as an insider with reassuring credentials.
 
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