Designing and optimizing clinical trials for long COVID, Vogel et al., 2024

Discussion in 'Long Covid research' started by Nightsong, Aug 15, 2024.

  1. Nightsong

    Nightsong Senior Member (Voting Rights)

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    Abstract

    Long COVID is a debilitating, multisystemic illness following a SARS-CoV-2 infection whose duration may be indefinite. Over four years into the pandemic, little knowledge has been generated from clinical trials.

    We analyzed the information available on ClinicalTrials.gov, and found that the rigor and focus of trials vary widely, and that the majority test non-pharmacological interventions with insufficient evidence. We highlight promising trials underway, and encourage the proliferation of clinical trials for treating Long COVID and other infection-associated chronic conditions and illnesses (IACCIs).

    We recommend several guidelines for Long COVID trials: First, pharmaceutical trials with potentially curative, primary interventions should be prioritized, and both drug repurposing and new drug development should be pursued.

    Second, study designs should be both rigorous and accessible, e.g., triple-blinded randomized trials that can be conducted remotely, without participants needing to leave their homes.

    Third, studies should have multiple illness comparator cohorts for IACCIs such as Myalgic Encephalomyelitis (ME/CFS) and dysautonomia, and screen for the full spectrum of symptomatology and pathologies of these illnesses.

    Fourth, studies should consider inclusion/exclusion criteria with an eye towards equity and breadth of representation, including participants of all races, ethnicities, and genders most impacted by COVID-19, and including all levels of illness severity.

    Fifth, involving patient-researchers in all aspects of studies brings immensely valuable perspectives that will increase the impact of trials. We also encourage the development of efficient clinical trial designs including methods to study several therapies in parallel.

    https://www.sciencedirect.com/science/article/pii/S0024320524005605 (Life Sciences; open access)
     
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  2. Arnie Pye

    Arnie Pye Senior Member (Voting Rights)

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    I suspect that little knowledge has been generated because so much of the research papers I've seen in recent years have been BPS-based and Psychology/Psychiatric based. Didn't the US government dish out lots of money? (Over a billion dollars?) But I am yet to hear about any benefit from it and I think I read that it had mostly been spent.

    One thing that made me very angry while I had my worst bouts of Covid (the first two of four) was that there was no real treatment for the condition. It just seemed to be a case of take an aspirin or a paracetamol and go to bed. I don't think anything has changed.

    So there isn't just Long Covid to be investigated, a treatment for the actual condition itself is required to shorten the course of the disease and reduce the chance of the patient getting Long Covid in the first place.
     
    Last edited: Aug 15, 2024
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  3. rvallee

    rvallee Senior Member (Voting Rights)

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    Even worse is that most of them are redundant. They add nothing at all to hundreds have already produced. They're clones of one another and are clearly done with zero care for the massive duplication of identical wastes of effort. Even worse than that is that all those interventions have been tested and failed before, in fact formed the first line of treatments deployed for LC. Despite evidence against. But they're testing them again! It's insane.

    Haven't read beyond and the abstract seems sensible and needed, but damn does medicine have fundamental issues to deal with here. I'm talking about needing an intervention. In the "we need to sit down with you and explain calmly and explicitly just how deeply you have fucked us and need to make a radical change in behavior, intent and motivation" and they need to accept it and commit to radical change.
     
    Last edited: Aug 15, 2024
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  4. rvallee

    rvallee Senior Member (Voting Rights)

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    Ah, reading it a bit and noticed the authors. Definitely needed and sensible. IMO the most important:
    From trials and research. Although the research so far has validated decades of controversy our way, it hasn't made an impact, but more importantly hasn't actually added anything that wasn't known on day 1. At least not that I'm aware of.
     
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