Keck Tilman, Strobl Andreas, Weinhaeusel Andreas, Funk Petra, Michaelis Martin
Department of ENT Medicine, Head and Neck Surgery, Hansa Private Hospital, Graz, Austria.
Department of ENT Medicine, Head and Neck Surgery, Ordensklinikum Linz, Krankenhaus Barmherzige Schwestern, Linz, Austria.
Front Pharmacol. 2021 Apr 30;12:666546. doi: 10.3389/fphar.2021.666546. eCollection 2021.
Experience in treating human coronavirus (HCoV) infections might help to identify effective compounds against novel coronaviruses. We therefore performed a secondary subgroup-analysis of data from an open-label, uncontrolled clinical trial published in 2015 investigating the proanthocyanidin-rich Pelargonium sidoides extract EPs 7630 in patients with the common cold. 120 patients with common cold and at least 2 out of 10 common cold symptoms received one film-coated 20 mg tablet EPs 7630 thrice daily for 10 days in an uncontrolled, interventional multicentre trial (ISRCTN65790556). At baseline, viral nucleic acids were detected by polymerase chain reaction. Common cold-associated symptoms and treatment satisfaction were evaluated after 5 days and at treatment end. Based on the data of patients with proof of viral nucleic acids, we compared the course of the disease in patients with or without HCoV infection. In 61 patients, viral nucleic acids were detected. Of these, 23 (37.7%) were tested positive for at least one HCoV (HCoV subset) and 38 (62.3%) for other viruses only (non-HCoV subset). Patients of both subsets showed a significant improvement of common cold symptoms already after 5 days of treatment, although the observed change tended to be more pronounced in the HCoV subset. At treatment end, more than 80% of patients of both groups were completely recovered or majorly improved. In both subsets, less than 22% of patients took concomitant paracetamol for antipyresis. The mean number of patients' days off work or school/college was similar (0.9 ± 2.6 days in HCoV subset vs 1.3 ± 2.8 days in non-HCoV subset). In both groups, most patients were satisfied or very satisfied with EPs 7630 treatment. EPs 7630 treatment outcomes of common cold patients with confirmed HCoV infection were as favourable as in patients with other viral infections. As this trial was conducted before the pandemic, there is currently no evidence from clinical trials for the efficacy of EPs 7630 in patients with SARS-CoV-2 infection. Dedicated non-clinical studies and clinical trials are required to elucidate the potential of EPs 7630 in the early treatment of HCoV infections.
治疗人类冠状病毒（HCoV）感染的经验可能有助于确定针对新型冠状病毒的有效化合物。因此，我们对2015年发表的一项开放标签、非对照临床试验的数据进行了二次亚组分析，该试验研究了富含原花青素的香叶天竺葵提取物EPs 7630对普通感冒患者的疗效。在一项非对照、介入性多中心试验（ISRCTN65790556）中，120名患有普通感冒且出现至少10种普通感冒症状中的2种的患者，每天三次服用一片20毫克的EPs 7630薄膜包衣片，持续10天。在基线时，通过聚合酶链反应检测病毒核酸。在治疗5天后和治疗结束时评估普通感冒相关症状和治疗满意度。基于有病毒核酸检测证明的患者数据，我们比较了感染或未感染HCoV的患者的病程。在61名患者中检测到病毒核酸。其中，23名（37.7%）至少一种HCoV检测呈阳性（HCoV亚组），38名（62.3%）仅其他病毒检测呈阳性（非HCoV亚组）。两个亚组的患者在治疗5天后普通感冒症状均有显著改善，尽管在HCoV亚组中观察到的变化往往更明显。在治疗结束时，两组中超过80%的患者完全康复或有显著改善。在两个亚组中，服用对乙酰氨基酚进行退热的患者均不到22%。患者的平均误工或误学天数相似（HCoV亚组为0.9±2.6天，非HCoV亚组为1.3±2.8天）。在两组中大多数患者对EPs 7630治疗感到满意或非常满意。确诊感染HCoV的普通感冒患者的EPs 7630治疗结果与其他病毒感染患者的结果一样良好。由于该试验是在大流行之前进行的，目前尚无来自临床试验的证据证明EPs 7630对SARS-CoV-2感染患者的疗效。需要进行专门的非临床研究和临床试验，以阐明EPs 7630在HCoV感染早期治疗中的潜力。
