• Mehrsa Jalalizadeh, Keini Buosi, Cristiane F Giacomelli, Patricia A F Leme, Karen L Ferrari, Franciele A V Dionato, Wandrey R S Brito, Natália S Brunetti, Aline R Maia, Joseane Morari, Ana C Pagliarone, Alessandro S Farias, Licio A Velloso, Maria A F Queiroz, Antonio C R Vallinoto, Marcio C Bajgelman, and Leonardo O Reis.
• UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil.
• J. Intern. Med. 2025 Jan 1; 297 (1): 607860-78.

BackgroundBacillus Calmette-Guérin (BCG) injected during the COVID-19 convalescence period was safe and enhanced recovery from anosmia and dysgeusia in the acute phase.ObjectivesTo report the long-term results of the BATTLE trial, BCG vaccine in adults with mild COVID-19.MethodsDesign: Double-blind, placebo-controlled, randomized (1:1) clinical trial.InterventionBCG intradermal vaccine and placebo.PatientsA total of 157 BCG and 142 placebo recipients participated in the 6-month follow-up, and 97 BCG and 95 placebo recipients participated in the 12-month follow-up.MeasurementsLong COVID symptoms and mechanistic analyses.ResultsBCG reduced hearing problems at 6 months (odds ratio [OR] = 0.26) and sleeping, concentration, memory, and vision problems at 12 months (OR = 0.45, 0.36, 0.38, and 0.36, respectively). Sensitivity analyses confirmed that long COVID-19 symptoms were reduced at the 6- and 12-month follow-ups (p = 0.010 and 0.031, respectively). BCG's crossover interaction paradoxically increased hair loss in women and decreased it in men at 6 months (p = 0.032). BCG immunomodulation is likely mediated through inhibition of Fas ligand expression in the blood and increased induction of IL6, IL10, interferon-induced transmembrane protein 3, and angiotensin-converting enzyme 2 in cultured human macrophages.ConclusionLong-term follow-up of the BATTLE trial participants revealed that BCG protects against long COVID development if administered within the COVID-19 convalescence period. The response to BCG was subject-specific, including a paradoxical crossover interaction based on sex.LimitationsNot tested for previous mycobacterial exposure; loss to follow-up, particularly at 12 months.© 2024 The Association for the Publication of the Journal of Internal Medicine.

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