Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark.
Clin Microbiol Infect. 2023 Oct;29(10):1313-1319. doi: 10.1016/j.cmi.2023.06.023. Epub 2023 Jun 22.
The COVID-19 pandemic has revealed a severe need for effective antiviral treatment. The objectives of this study were to assess if pre-emptive treatment with amantadine for COVID-19 in non-hospitalized persons ≥40 years or adults with comorbidities was able to prevent disease progression and hospitalization. Primary outcomes were clinical status on day 14.
Between 9 June 2021 and 27 January 2022, this randomized, double-blinded, placebo-controlled, single-centre clinical trial included 242 subjects with a follow-up period of 90 days. Subjects were randomly assigned 1:1 to either amantadine 100 mg or placebo twice daily for 5 days. The inclusion criteria were confirmed SARS-CoV-2 infection and at least one of (a) age ≥40 years, age ≥18 years and (b) at least one comorbidity, or (c) body mass index ≥30. The study protocol was published at www.
gov (unique protocol #02032021) and at www.clinicaltrialregister.eu (EudraCT-number 2021-001177-22).
With 121 participants in each arm, we found no difference in the primary endpoint with 82 participants in the amantadine arm, and 92 participants in the placebo arm with no limitations to activities, respectively, and 25 and 37 with limitations to activities in the amantadine arm and the placebo arm, respectively. No participants in either group were admitted to hospital or died. The OR of having state severity increased by 1 in the amantadine group versus placebo was 1.8 (CI 1.0-3.3, [p 0.051]). On day 7, one participant was hospitalized in each group; throughout the study, this increased to five and three participants for amantadine versus placebo treatment (p 0.72). Similarly, on day 7, there was no difference in the status of oropharyngeal swabs. Most participants (108 in each group) were SARS-CoV-2 RNA positive (p 0.84).
We found no effect of amantadine on disease progression of SARS-CoV-2 infection.
新冠疫情凸显了对有效抗病毒治疗的迫切需求。本研究旨在评估对非住院的≥40 岁人群或合并症成年人进行金刚烷胺预防性治疗是否能预防疾病进展和住院。主要结局为第 14 天的临床状况。
本随机、双盲、安慰剂对照、单中心临床试验于 2021 年 6 月 9 日至 2022 年 1 月 27 日进行，共纳入 242 例患者，随访期为 90 天。患者按 1:1 随机分为金刚烷胺 100mg 或安慰剂，每日 2 次，共 5 天。纳入标准为确诊的 SARS-CoV-2 感染和至少符合以下一项：(a)≥40 岁，年龄≥18 岁和(b)至少有一种合并症，或(c)体重指数≥30。研究方案在 www.clinicaltrials.gov（独特方案编号 02032021）和 www.clinicaltrialregister.eu（EudraCT 编号 2021-001177-22）上公布。
金刚烷胺组和安慰剂组各有 121 例患者，主要终点无差异，分别有 82 例和 92 例患者无活动受限，分别有 25 例和 37 例患者活动受限。两组均无患者住院或死亡。与安慰剂组相比，金刚烷胺组状态严重程度增加 1 的比值比为 1.8（95%CI 1.0-3.3，[p=0.051]）。第 7 天，每组各有 1 例患者住院；在整个研究过程中，金刚烷胺组和安慰剂组分别增加到 5 例和 3 例（p=0.72）。同样，第 7 天，口咽拭子的状况也没有差异。大多数患者（每组 108 例）的 SARS-CoV-2 RNA 检测为阳性（p=0.84）。
我们未发现金刚烷胺对 SARS-CoV-2 感染疾病进展有影响。
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