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Proal AD, Aleman S, Bomsel M, Brodin P, Buggert M, Cherry S, Chertow DS, Davies HE, Dupont CL, Deeks SG, Ely EW, Fasano A, Freire M, Geng LN, Griffin DE, Henrich TJ, Hewitt SM, Iwasaki A, Krumholz HM, Locci M, Marconi VC, Mehandru S, Muller-Trutwin M, Painter MM, Pretorius E, Price DA, Putrino D, Qian Y, Roan NR, Salmon D, Tan GS, VanElzakker MB, Wherry EJ, Van Weyenbergh J, Yonker LM, Peluso MJ
Lancet Infect Dis - (-) - [2025-02-10; online 2025-02-10]
There are no approved treatments for post-COVID-19 condition (also known as long COVID), a debilitating disease state following SARS-CoV-2 infection that is estimated to affect tens of millions of people. A growing body of evidence shows that SARS-CoV-2 can persist for months or years following COVID-19 in a subset of individuals, with this reservoir potentially driving long-COVID symptoms or sequelae. There is, therefore, an urgent need for clinical trials targeting persistent SARS-CoV-2, and several trials of antivirals or monoclonal antibodies for long COVID are underway. However, because mechanisms of SARS-CoV-2 persistence are not yet fully understood, such studies require important considerations related to the mechanism of action of candidate therapeutics, participant selection, duration of treatment, standardisation of reservoir-associated biomarkers and measurables, optimal outcome assessments, and potential combination approaches. In addition, patient subgroups might respond to some interventions or combinations of interventions, making post-hoc analyses crucial. Here, we outline these and other key considerations, with the goal of informing the design, implementation, and interpretation of trials in this rapidly growing field. Our recommendations are informed by knowledge gained from trials targeting the HIV reservoir, hepatitis C, and other RNA viruses, as well as precision oncology, which share many of the same hurdles facing long-COVID trials.
PubMed 39947217
DOI 10.1016/S1473-3099(24)00769-2
Crossref 10.1016/S1473-3099(24)00769-2
pii: S1473-3099(24)00769-2