COVID19 is a high burden for medicine and society as still no specific therapy exists. Most patients depend on symptomatic treatment, comparable to the symptomatic treatment in common respiratory infection e.g., Acetaminophen or Ibuprofen. Many cases of COVID19 show mild forms without need of hospitalization. In this randomized, open-label, multicentre, comparative trial we analysed the efficacy, safety, and tolerability of the herbal medicinal product BNO 1030 in mild cases of COVID-19 to offer an additional symptomatic relive. The study was designed as an open label randomized, prospective, multicentred clinical trial. Out of 133 screened outpatients aged 18 to 70 with mild COVID-19 symptoms 120 patients were randomised (1:1) in 2 parallel groups. The main group received BNO 1030 in addition to symptomatic therapy (acetaminophen or ibuprofen). The control group got a symptomatic therapy only. The patients with laboratory proven COVID 19 were included for the final analyses: 47 – in the main group and 46 – in the control one. The evaluation criteria were dynamics of the symptoms: hyperthermia, myalgia, nasal congestion, nasal discharge, coughing, anosmia, rhinolalia, sore throat, duration of the use of antipyretics (clinically significant fever). These symptoms were assessed during the physician’s visit on a 4-point scale (0 — absent, 1 — insignificant, 2 — moderate, 3 — strong/pronounced) and self- assessed via ten-point visual analogue scale (VAS) daily in a patient’s diary. The primary endpoint was the decrease of the average score compared to the baseline defined as “therapeutic benefit” from the usage of BNO 1030. In the comparison of both groups over the treatment time, the main group (n = 47) showed a greater decrease in the severity of symptoms of fever, myalgia, nasal congestion, coughing, anosmia and rhinolalia, assessed by the doctor on a 4-point scale on V2 (4th day) and V3 (14th day) compared to those on V1, as well as a reduction of the antipyretics intake duration (p < 0.05). Significant differences of the main group were obtained, too, based on the results of symptoms self-assessment by the patient. The “therapeutic benefit from the use of BNO 1030 was 3 days. There is an increase in the number of recovered patients from 73.9–96.6 % according to the average symptom score, and a decrease in the number of hospitalized patients from 8.6–4.4 % in the main group., as compared to the data of the control group (p < 0.05). All patients tolerated the herbal medicine well, with no adverse drug reactions being reported. BNO 1030 (Imupret®) offers a safe and effective treatment benefit in patients with mild forms of diagnosed COVID-19 aged 18–70 in addition to symptomatic treatment with acetaminophen or NSAIDs. COVID 19 positive patients treated with Imupret showed an earlier relive of symptoms when being treated with BNO 1030. This trial was registered in ClinicalTrial.gov: NCT04797936 .

中文翻译：

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一项随机、开放标签、多中心、BNO 1030 提取物的疗效、安全性和耐受性比较研究，含有棉花糖根、洋甘菊花、马尾草、核桃叶、西洋蓍草、橡树皮、蒲公英草本，用于治疗轻度形式的 COVID-19

COVID19 对医学和社会来说是一个沉重的负担，因为仍然没有特定的治疗方法。大多数患者依赖于对症治疗，类似于常见呼吸道感染的对症治疗，例如对乙酰氨基酚或布洛芬。许多 COVID19 病例表现出轻微的形式，无需住院。在这项随机、开放标签、多中心、比较试验中，我们分析了草药产品 BNO 1030 在 COVID-19 轻度病例中的疗效、安全性和耐受性，以提供额外的症状缓解。该研究被设计为一项开放标签随机、前瞻性、多中心临床试验。在 133 名年龄在 18 至 70 岁且具有轻度 COVID-19 症状的门诊患者中，120 名患者被随机分配 (1:1) 分成 2 个平行组。除了对症治疗（对乙酰氨基酚或布洛芬）外，主要组还接受了 BNO 1030。对照组仅给予对症治疗。实验室证实为 COVID 19 的患者被纳入最终分析：47 名（主要组）和 46 名（对照组）。评估标准是症状的动态：体温过高、肌痛、鼻塞、流鼻涕、咳嗽、嗅觉丧失、鼻炎、喉咙痛、使用退热药的持续时间（临床显着发热）。这些症状在医生就诊期间以 4 分制（0 — 不存在，1 — 不显着，2 — 中等，3 — 强烈/明显）进行评估，并通过每天 10 点视觉模拟量表 (VAS) 进行自我评估。病人日记。主要终点是与基线相比平均评分的降低，基线定义为使用 BNO 1030 的“治疗获益”。 在治疗时间段的两组比较中，主要组（n = 47）显示发热、肌痛、鼻塞、咳嗽、嗅觉丧失和鼻涕等症状的严重程度下降幅度更大，由医生在 V2（第 4 天）和 V3（第 3 天）进行 4 分制评估（第 14 天）与 V1 相比，以及退热药摄入持续时间的减少（p < 0.05）。根据患者的症状自我评估结果，也获得了主要组的显着差异。“使用 BNO 1030 的治疗益处是 3 天。与对照组的数据相比，根据平均症状评分，康复患者人数从 73.9-96.6% 增加，住院患者人数从 8.6-4.4% 减少。组 (p < 0.05)。所有患者都对草药耐受良好，无药物不良反应报告。除了使用对乙酰氨基酚或非甾体抗炎药进行对症治疗外，BNO 1030 (Imupret®) 还为 18-70 岁的轻度确诊 COVID-19 患者提供安全有效的治疗益处。接受 Imupret 治疗的 COVID 19 阳性患者在接受 BNO 1030 治疗时表现出较早的症状复发。该试验已在 ClinicalTrial.gov 注册：NCT04797936。