Thread by @PutrinoLab

I want to thank everyone for the interest in this work that we completed in a #LongCOVID cohort with this novel device. I always appreciate feedback and want to thank folks for holding me accountable to a high standard of communication. To that end, I want to re-clarify this
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thread: this was a safety/feasibility trial which means that our primary endpoints were related to safety and feasibility. In the paper, we state clearly that we hit those endpoints: no device-related adverse events and 100% adherence to the protocol in all participants. That
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is great for a safety/feasibility trial. I then went on to express excitement that some cognitive scores moved. I understand that folks have (rightly) pointed out that without a larger sample size and correcting for multiple comparisons we can’t make definitive statements
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about efficacy. This is correct. As I pointed out in the original thread, we will be getting a multisite pivotal trial to prove or disprove efficacy off the ground shortly. I apologize if my enthusiasm for observed mobility in the cognitive scores overshadowed the stated need
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for a larger pivotal. The larger pivotal is the crucial next step. In addition, as is our way with all research at our center, we are delving into biomarker analysis to better understand if correlations exist between blood biomarkers and cognitive outcomes in this cohort. Most
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importantly: enthusiasm should not ever trump rigor as we carefully, yet urgently pursue actionable treatments for people with #LongCOVID and other infection-associated chronic conditions and illnesses such as #MECFS and chronic tick- and vector-borne illness. We don’t take
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the trust of this community lightly, but we also want to share meaningful data rapidly. I remain highly enthusiastic about these pilot data and believe that they strongly support progression to a larger pivotal trial to explore efficacy, which is exactly the plan. Thanks as

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always to this great and rigorous community. 🙏🏻

/end