Therapeutic BCG vaccine protects against long COVID: The BATTLE randomized clinical trial.

Autor: Jalalizadeh, Mehrsa, Buosi, Keini, Giacomelli, Cristiane F., Leme, Patricia A.F., Ferrari, Karen L., Dionato, Franciele A.V., Brito, Wandrey R.S., Brunetti, Natália S., Maia, Aline R., Morari, Joseane, Pagliarone, Ana C., Farias, Alessandro S., Velloso, Licio A., Queiroz, Maria A.F., Vallinoto, Antonio C.R., Bajgelman, Marcio C., Reis, Leonardo O.
Zdroj: Journal of Internal Medicine; Jan2025, Vol. 297 Issue 1, p60-78, 19p
Abstrakt: Background: Bacillus Calmette–Guérin (BCG) injected during the COVID‐19 convalescence period was safe and enhanced recovery from anosmia and dysgeusia in the acute phase. Objectives: To report the long‐term results of the BATTLE trial, BCG vaccine in adults with mild COVID‐19. Methods: Design: Double‐blind, placebo‐controlled, randomized (1:1) clinical trial. Intervention: BCG intradermal vaccine and placebo. Patients: A 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. Measurements: Long COVID symptoms and mechanistic analyses. Results: BCG 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. Conclusion: Long‐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. Limitations: Not tested for previous mycobacterial exposure; loss to follow‐up, particularly at 12 months. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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