Ben Abdallah Saoussen, Mhalla Yosra, Trabelsi Imen, Sekma Adel, Youssef Rim, Bel Haj Ali Khaoula, Ben Soltane Houda, Yacoubi Hajer, Msolli Mohamed Amine, Stambouli Nejla, Beltaief Kaouthar, Grissa Mohamed Habib, Khrouf Meriem, Mezgar Zied, Loussaief Chawki, Bouida Wahid, Razgallah Rabie, Hezbri Karima, Belguith Asma, Belkacem Naouel, Dridi Zohra, Boubaker Hamdi, Boukef Riadh, Nouira Semir
Medical Intensive Care Unit, Fattouma Bourguiba University Hospital, Monastir, Tunisia.
Laboratory of Microbiology, Fattouma Bourguiba University Hospital, Monastir, Tunisia.
Clin Infect Dis. 2023 Jan 13;76(2):185-191. doi: 10.1093/cid/ciac807.
Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection.
We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19-related hospitalization for outpatients.
190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34-1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21-.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33-.99). Consistent results were observed in prespecified subgroups of patients aged <65 years, those with comorbidity, and those who needed oxygen therapy at baseline. Length of hospital stay was shorter in the zinc group versus the placebo group (difference: 3.5 days; 95% CI 2.76-4.23) in the inpatient group; duration of COVID-19 symptoms decreased with zinc treatment versus placebo in outpatients (difference: 1.9 days; 95% CI .62-2.6). No severe adverse events were observed during the study.
Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.
补充锌已被视为治疗2019冠状病毒病（COVID-19）的一种潜在疗法。我们旨在研究锌对成年COVID-19感染患者的疗效。
我们进行了一项前瞻性、随机、双盲、安慰剂对照的多中心试验。COVID-19检测呈阳性且无终末器官衰竭的患者被随机分为口服锌组（n = 231）或匹配的安慰剂组（n = 239），为期15天。主要联合结局是随机分组后30天内死于COVID-19或入住重症监护病房（ICU）。次要结局包括住院患者的住院时间以及门诊患者因COVID-19住院的COVID-19症状持续时间。
190例患者（40.4%）为非住院患者，280例患者（59.6%）为住院患者。锌组30天死亡率为6.5%，安慰剂组为9.2%（比值比：0.68；95%置信区间0.34 - 1.35）；ICU入住率分别为5.2%和11.3%（比值比：0.43；95%置信区间0.21 - 0.87）。锌组的联合结局低于安慰剂组（比值比：0.58；95%置信区间0.33 - 0.99）。在年龄<65岁、有合并症以及基线时需要吸氧治疗的预设亚组患者中观察到了一致的结果。住院患者中，锌组的住院时间短于安慰剂组（差异：3.5天；95%置信区间2.76 - 4.23）；门诊患者中，与安慰剂相比，锌治疗使COVID-19症状持续时间缩短（差异：1.9天；95%置信区间0.62 - 2.6）。研究期间未观察到严重不良事件。
我们的结果表明，在COVID-19患者中，口服锌可降低30天死亡率、ICU入住率，并可缩短症状持续时间。临床试验注册。ClinicalTrials.gov，NCT05212480。
