We’ve released a new paper on designing & optimizing clinical trials for #LongCOVID!
Strong, high-impact trials are critical & most current ones are insufficient. The paper gives guidance on treatments, outcomes, design, participant inclusion, & more.
1/sciencedirect.com/science/articl…
Strong, high-impact trials are critical & most current ones are insufficient. The paper gives guidance on treatments, outcomes, design, participant inclusion, & more.
1/sciencedirect.com/science/articl…
It also gives an overview of the promising interventions being trialed (as of May 2024) for #LongCovid and their targets, including viral persistence, immune dysfunction, endothelial dysfunction, and symptom management. 2/ 
Some other key points:
-Trials should prioritize potentially curative interventions, including repurposed drugs and the development of new drugs.
-Combinations of therapies may be beneficial or necessary, which should be considered in clinical trial design. 3/
-Trials should prioritize potentially curative interventions, including repurposed drugs and the development of new drugs.
-Combinations of therapies may be beneficial or necessary, which should be considered in clinical trial design. 3/
-Trial design should consider illness comparator cohorts, as well as multiple therapeutic arms, such as basket, umbrella, and platform trials. 4/
-Studies should include historically under-represented participants, such as severe housebound and bedbound patients; gender, racially, and ethnically diverse individuals; and those living in rural areas. 5/
-Trials must be both rigorous and accessible – for example, parallel triple-blinded randomized trials that can be conducted remotely and/or without participants needing to leave their home. 6/
Strong endpoints and outcome measures are possible even in the absence of a specific biomarker. Tools such as the FUNCAP, COMPASS-31, 2-day CPET, specific cognitive dysfunction tests, and cerebral blood flow can measure some of the most debilitating components of #LongCovid. 7/
Biomedical endpoints should be included alongside other outcomes to discover pathophysiological mechanisms and potentially connect them to treatment responses. 8/
Finally, patient-led studies and studies with patient scientists and high patient engagement are most likely to meet these recommendations, and support the design of effective and comprehensive research. 9/
Enormous thank you to @julialmv for leading and co-authors @ChronicResearch, @ahhrrr, @LisaAMcCorkell, @twjaudon, @TheMegascope, @ahandvanish, and Alison Cohen for their tremendous work! 10/
For more information, to collaborate, or to cover this paper, please reach out to team@patientledresearch.com! 11/
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