Castro-Balado Ana, Novo-Veleiro Ignacio, Vázquez-Agra Néstor, Barbeito-Castiñeiras Gema, Estany-Gestal Ana, Trastoy-Pena Rocío, González-Barcia Miguel, Zarra-Ferro Irene, Del Río-Garma María Carmen, Crespo-Diz Carlos, Delgado-Sánchez Olga, Otero-Espinar Francisco J, Mondelo-García Cristina, Pose-Reino Antonio, Fernández-Ferreiro Anxo
Pharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
Clinical Pharmacology Group, Health Research Institute of Santiago de Compostela (IDIS), 15706 Santiago de Compostela, Spain.
Pharmaceutics. 2023 Feb 16;15(2):667. doi: 10.3390/pharmaceutics15020667.
Inhaled ethanol in the early stages of SARS-CoV-2 infection may reduce the viral load, decreasing progression and improving prognosis. The ALCOVID-19 trial was designed to study the efficacy and safety of inhaled ethanol in older adults at initial phases of infection.
Randomized, triple-blind, placebo-controlled phase II clinical trial. Experimental group (n = 38) inhaled 65° ethanol through an oxygen flow, while in the control group (n = 37), water for injection was used. General endpoint was to evaluate disease progression according to the modified World Health Organization (WHO) Clinical Progression Scale. Specific effectiveness endpoints were body temperature, oxygen saturation, viral load assessed by cycle threshold (Ct) on real-time polymerase chain reaction (RT-PCR), analytical biomarkers and use of antibiotics or corticosteroids. Specific safety outcomes were the absence of ethanol in plasma, electrographic, analytical, or respiratory alterations.
In the intention-to-treat population, no differences were found regarding disease progression. Mean Ct values increased over time in both groups, being numerically higher in the ethanol group, reaching a value above 33 only in the ethanol group on day 14, a value above which patients are considered non-infective. No differences were found in the other specific effectiveness endpoints. Inhaled ethanol was proven to be safe as no plasma ethanol was detected, and there were no electrocardiographic, analytical, or respiratory alterations.
The efficacy of inhaled ethanol in terms of the progression of SARS-CoV-2 infection was not demonstrated in the present trial. However, it is positioned as a safe treatment for elderly patients with early-stage COVID-19.
在新型冠状病毒2（SARS-CoV-2）感染的早期吸入乙醇可能会降低病毒载量，减少病情进展并改善预后。ALCOVID-19试验旨在研究吸入乙醇在感染初期老年患者中的疗效和安全性。
随机、三盲、安慰剂对照的II期临床试验。实验组（n = 38）通过氧气流吸入65°乙醇，而对照组（n = 37）使用注射用水。总体终点是根据改良的世界卫生组织（WHO）临床进展量表评估疾病进展。具体有效性终点包括体温、血氧饱和度、通过实时聚合酶链反应（RT-PCR）的循环阈值（Ct）评估的病毒载量、分析生物标志物以及抗生素或皮质类固醇的使用情况。具体安全性结果是血浆中无乙醇、无心电图、分析或呼吸改变。
在意向性治疗人群中，未发现疾病进展方面的差异。两组的平均Ct值均随时间增加，乙醇组在数值上更高，仅在第14天乙醇组达到高于33的值，高于此值的患者被认为无传染性。在其他具体有效性终点方面未发现差异。吸入乙醇被证明是安全的，因为未检测到血浆乙醇，也没有心电图、分析或呼吸改变。
本试验未证明吸入乙醇在SARS-CoV-2感染进展方面的疗效。然而，它被定位为早期新型冠状病毒肺炎老年患者的一种安全治疗方法。
