Silvia Gómez-Zorrilla , Elena Sendra , Juan Du , Mercé Espona , Alejandro Fierro-Villegas , Ana Siverio , Alicia Rodriguez-Alarcón , Silvia Castañeda , Inmaculada López Montesinos , Cristina Plata , Itziar Arrieta-Aldea , Jade Soldado-Folgado , Natalia García-Giralt , Rubén Vicente , Robert Güerri-Fernández
{"title":"锌辅助治疗SARS-CoV-2:一项随机临床试验","authors":"Silvia Gómez-Zorrilla , Elena Sendra , Juan Du , Mercé Espona , Alejandro Fierro-Villegas , Ana Siverio , Alicia Rodriguez-Alarcón , Silvia Castañeda , Inmaculada López Montesinos , Cristina Plata , Itziar Arrieta-Aldea , Jade Soldado-Folgado , Natalia García-Giralt , Rubén Vicente , Robert Güerri-Fernández","doi":"10.1016/j.jtemb.2025.127778","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Zinc is a trace element with a key role in immune function and has demonstrated antiviral and anti-inflammatory properties. Low plasma zinc levels have been associated with poor outcomes in COVID-19. This study aims to evaluate the efficacy and safety of zinc supplementation as an adjuvant therapy in hospitalized patients with COVID-19.</div></div><div><h3>Methods</h3><div>A single-center, randomized, open-label clinical trial between May and December 2021. Adults hospitalized with confirmed COVID-19 requiring hospitalization were randomized 1:1 to receive standard of care (SoC) with or without oral zinc acetate (90 mg/day) for 14 days. The primary endpoint was disease progression, defined as critical care requirement (ICU admission) or death. Secondary outcomes included time to clinical recovery, hospital length of stay, WHO clinical scale improvement, inflammatory markers, antibody response, and safety.</div></div><div><h3>Results</h3><div>Seventy-one patients were randomized (35 zinc versus 34 SoC). Disease progression occurred in 5.7 % of the zinc group versus 23.5 % in the SoC group (OR 0.21, 95 %CI = 0.03–0.96,). Mean recovery time was significantly shorter in the zinc group (7.4 ± 6.1 versus 13.1 ± 9.7 days, p = 0.006) and a trend to a faster recovery was observed in the Cox proportional hazards model in the intervention group HR of 1.670 (95 % CI: 0.948–2.942), p = 0.076. WHO scale improvement attaining a < 1 points at day 14 was greater in the zinc group (74.3 % versus 42.4 %, p = 0.009). Antibody levels were higher in the SoC group at days 14 and 28. No adverse events were attributed to zinc.</div></div><div><h3>Conclusions</h3><div>Adjunctive zinc supplementation to standard of care reduced disease progression and showed a trend to accelerated clinical recovery in hospitalized COVID-19 patients, supporting the potential role of zinc in managing viral respiratory infections.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov identifier, NCT05778383.</div></div>","PeriodicalId":49970,"journal":{"name":"Journal of Trace Elements in Medicine and Biology","volume":"92 ","pages":"Article 127778"},"PeriodicalIF":3.6000,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Zinc adjuvant treatment in SARS-CoV-2: A randomized clinical trial\",\"authors\":\"Silvia Gómez-Zorrilla , Elena Sendra , Juan Du , Mercé Espona , Alejandro Fierro-Villegas , Ana Siverio , Alicia Rodriguez-Alarcón , Silvia Castañeda , Inmaculada López Montesinos , Cristina Plata , Itziar Arrieta-Aldea , Jade Soldado-Folgado , Natalia García-Giralt , Rubén Vicente , Robert Güerri-Fernández\",\"doi\":\"10.1016/j.jtemb.2025.127778\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>Zinc is a trace element with a key role in immune function and has demonstrated antiviral and anti-inflammatory properties. Low plasma zinc levels have been associated with poor outcomes in COVID-19. This study aims to evaluate the efficacy and safety of zinc supplementation as an adjuvant therapy in hospitalized patients with COVID-19.</div></div><div><h3>Methods</h3><div>A single-center, randomized, open-label clinical trial between May and December 2021. Adults hospitalized with confirmed COVID-19 requiring hospitalization were randomized 1:1 to receive standard of care (SoC) with or without oral zinc acetate (90 mg/day) for 14 days. The primary endpoint was disease progression, defined as critical care requirement (ICU admission) or death. Secondary outcomes included time to clinical recovery, hospital length of stay, WHO clinical scale improvement, inflammatory markers, antibody response, and safety.</div></div><div><h3>Results</h3><div>Seventy-one patients were randomized (35 zinc versus 34 SoC). Disease progression occurred in 5.7 % of the zinc group versus 23.5 % in the SoC group (OR 0.21, 95 %CI = 0.03–0.96,). Mean recovery time was significantly shorter in the zinc group (7.4 ± 6.1 versus 13.1 ± 9.7 days, p = 0.006) and a trend to a faster recovery was observed in the Cox proportional hazards model in the intervention group HR of 1.670 (95 % CI: 0.948–2.942), p = 0.076. WHO scale improvement attaining a < 1 points at day 14 was greater in the zinc group (74.3 % versus 42.4 %, p = 0.009). Antibody levels were higher in the SoC group at days 14 and 28. 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Zinc adjuvant treatment in SARS-CoV-2: A randomized clinical trial
Introduction
Zinc is a trace element with a key role in immune function and has demonstrated antiviral and anti-inflammatory properties. Low plasma zinc levels have been associated with poor outcomes in COVID-19. This study aims to evaluate the efficacy and safety of zinc supplementation as an adjuvant therapy in hospitalized patients with COVID-19.
Methods
A single-center, randomized, open-label clinical trial between May and December 2021. Adults hospitalized with confirmed COVID-19 requiring hospitalization were randomized 1:1 to receive standard of care (SoC) with or without oral zinc acetate (90 mg/day) for 14 days. The primary endpoint was disease progression, defined as critical care requirement (ICU admission) or death. Secondary outcomes included time to clinical recovery, hospital length of stay, WHO clinical scale improvement, inflammatory markers, antibody response, and safety.
Results
Seventy-one patients were randomized (35 zinc versus 34 SoC). Disease progression occurred in 5.7 % of the zinc group versus 23.5 % in the SoC group (OR 0.21, 95 %CI = 0.03–0.96,). Mean recovery time was significantly shorter in the zinc group (7.4 ± 6.1 versus 13.1 ± 9.7 days, p = 0.006) and a trend to a faster recovery was observed in the Cox proportional hazards model in the intervention group HR of 1.670 (95 % CI: 0.948–2.942), p = 0.076. WHO scale improvement attaining a < 1 points at day 14 was greater in the zinc group (74.3 % versus 42.4 %, p = 0.009). Antibody levels were higher in the SoC group at days 14 and 28. No adverse events were attributed to zinc.
Conclusions
Adjunctive zinc supplementation to standard of care reduced disease progression and showed a trend to accelerated clinical recovery in hospitalized COVID-19 patients, supporting the potential role of zinc in managing viral respiratory infections.
期刊介绍:
The journal provides the reader with a thorough description of theoretical and applied aspects of trace elements in medicine and biology and is devoted to the advancement of scientific knowledge about trace elements and trace element species. Trace elements play essential roles in the maintenance of physiological processes. During the last decades there has been a great deal of scientific investigation about the function and binding of trace elements. The Journal of Trace Elements in Medicine and Biology focuses on the description and dissemination of scientific results concerning the role of trace elements with respect to their mode of action in health and disease and nutritional importance. Progress in the knowledge of the biological role of trace elements depends, however, on advances in trace elements chemistry. Thus the Journal of Trace Elements in Medicine and Biology will include only those papers that base their results on proven analytical methods.
Also, we only publish those articles in which the quality assurance regarding the execution of experiments and achievement of results is guaranteed.