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, Leonardo O Reis
{"title":"治疗性卡介苗可预防长效 COVID：BATTLE 随机临床试验。","authors":"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, Leonardo O Reis","doi":"10.1111/joim.20033","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bacillus Calmette-Guérin (BCG) injected during the COVID-19 convalescence period was safe and enhanced recovery from anosmia and dysgeusia in the acute phase.</p><p><strong>Objectives: </strong>To report the long-term results of the BATTLE trial, BCG vaccine in adults with mild COVID-19.</p><p><strong>Methods: </strong>Design: Double-blind, placebo-controlled, randomized (1:1) clinical trial.</p><p><strong>Intervention: </strong>BCG intradermal vaccine and placebo.</p><p><strong>Patients: </strong>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.</p><p><strong>Measurements: </strong>Long COVID symptoms and mechanistic analyses.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Limitations: </strong>Not tested for previous mycobacterial exposure; loss to follow-up, particularly at 12 months.</p>","PeriodicalId":196,"journal":{"name":"Journal of Internal Medicine","volume":" ","pages":""},"PeriodicalIF":9.0000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Therapeutic BCG vaccine protects against long COVID: The BATTLE randomized clinical trial.\",\"authors\":\"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, Leonardo O Reis\",\"doi\":\"10.1111/joim.20033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bacillus Calmette-Guérin (BCG) injected during the COVID-19 convalescence period was safe and enhanced recovery from anosmia and dysgeusia in the acute phase.</p><p><strong>Objectives: </strong>To report the long-term results of the BATTLE trial, BCG vaccine in adults with mild COVID-19.</p><p><strong>Methods: </strong>Design: Double-blind, placebo-controlled, randomized (1:1) clinical trial.</p><p><strong>Intervention: </strong>BCG intradermal vaccine and placebo.</p><p><strong>Patients: </strong>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.</p><p><strong>Measurements: </strong>Long COVID symptoms and mechanistic analyses.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Limitations: </strong>Not tested for previous mycobacterial exposure; loss to follow-up, particularly at 12 months.</p>\",\"PeriodicalId\":196,\"journal\":{\"name\":\"Journal of Internal Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":9.0000,\"publicationDate\":\"2024-11-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Internal Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/joim.20033\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Internal Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/joim.20033","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Therapeutic BCG vaccine protects against long COVID: The BATTLE randomized clinical trial.
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.
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.
期刊介绍：
JIM – The Journal of Internal Medicine, in continuous publication since 1863, is an international, peer-reviewed scientific journal. It publishes original work in clinical science, spanning from bench to bedside, encompassing a wide range of internal medicine and its subspecialties. JIM showcases original articles, reviews, brief reports, and research letters in the field of internal medicine.
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