The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID.

Autor:	Krumholz HM; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT; Center for Infection and Immunity, Yale School of Medicine, New Haven, CT. Electronic address: harlan.krumholz@yale.edu., Sawano M; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT., Bhattacharjee B; Center for Infection and Immunity, Yale School of Medicine, New Haven, CT; Department of Immunobiology, Yale School of Medicine, New Haven, CT., Caraballo C; Department of Internal Medicine, Yale School of Medicine, New Haven, CT., Khera R; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT; Section of Health Informatics, Department of Biostatistics, Yale School of Public Health, New Haven, CT., Li SX; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT., Herrin J; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT., Coppi A; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT., Holub J; Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT., Henriquez Y; Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT., Johnson MA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT., Goddard TB; Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT., Rocco E; Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT., Hummel AC; Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT., Al Mouslmani M; Yale School of Medicine, New Haven, CT., Putrino DF; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY., Carr KD; Trusted Medical, Middletown, CT., Carvajal-Gonzalez S; Pfizer, Inc., Cambridge, Mass and New York, NY., Charnas L; Pfizer, Inc., Cambridge, Mass and New York, NY., De Jesus M; Pfizer, Inc., Cambridge, Mass and New York, NY., Ziegler FW 3rd; Law Offices of Barry J. Gammons, Nashville, TN., Iwasaki A; Center for Infection and Immunity, Yale School of Medicine, New Haven, CT; Department of Immunobiology, Yale School of Medicine, New Haven, CT; Howard Hughes Medical Institute, Chevy Chase, MD.
Jazyk:	angličtina
Zdroj:	The American journal of medicine [Am J Med] 2024 May 10. Date of Electronic Publication: 2024 May 10.
DOI:	10.1016/j.amjmed.2024.04.030
Abstrakt:	Background: Individuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID. Methods: The PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants' homes. The study drug is shipped directly to participants' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders. Conclusion: The PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID. (Copyright © 2024. Published by Elsevier Inc.)
Databáze:	MEDLINE
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