Using real-world data to accelerate the search for long COVID therapies.

Long COVID, a spectrum of symptoms and syndromes that can develop after SARS-COV-2 infection, can significantly affect patients' health, quality of life and impact their ability to productively function in society. There is currently no approved therapy for Long COVID and there is an urgent need for rigorous clinical trials to find such treatments. Although research into the pathophysiology of Long COVID is advancing, investigations into treatment for patients remain underfunded and, as a result, understudied. Owing to the urgency of the Long COVID pandemic and as a research collaborative across a diversity of biomedical innovation value propositions, we are calling for a new approach that parallelizes pathophysiologic and therapeutic research into this condition, leveraging patient-centered research and real-world data to generate hypotheses to assess the effectiveness of existing FDA approved drugs. Accelerated discovery of therapeutics for Long COVID can then be confirmed through efficient and cost-effective adaptive platform clinical trials.
Competing Interests: Declaration of competing interest Shira R. Strongin (SRS) contributed to this work while consulting at the Critical Path Institute. Following this contribution, SRS joined the National Center for Advancing Translational Science (NCATS) at the National Institutes of Health (NIH) as a contractor employed by Axle Informatics (Axle). Since joining NCATS through Axle, SRS has not made additional contributions. NCATS and AI did not provide any data, funding, or scientific input to this work, and the content of this manuscript does not reflect the official views of NCATS or Axle. Marco Schito and Pamela Dasher work for Critical Path Institute, which is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 55 % funded by the FDA/HHS, totaling $17,612,250, and 45 % funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government. Anup P. Challa (APC) contributed to this work while at Vanderbilt University Medical Center. Following this contribution, APC joined AstraZeneca Pharmaceuticals (AZ)—which studies and markets COVID-19 prophylactic and therapeutic products—as an employee and shareholder. After joining AZ, APC did not participate in this research and did not provide any guidance on product-specific or advocacy topics. AZ did not provide any data, funding, or scientific input to this work, and the content of this manuscript does not reflect AZ's official views. Linda N. Geng has received research funding from Pfizer, Inc. Pfizer did not provide any data, funding, or scientific input to this work, and the content of this manuscript does not reflect Pfizer's official views.
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