Giang Tran Van, Hoa Le Nguyen Minh, Hien Tran Thi, Cuong Quach Duy, Cap Nguyen Trung, Lam Vuong Nguyen, Thach Pham Ngoc
Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM.
Department of Infectious Diseases, Hanoi Medical University, Hanoi, VNM.
Cureus. 2023 Jul 26;15(7):e42484. doi: 10.7759/cureus.42484. eCollection 2023 Jul.
Background Coronavirus disease 2019 (COVID-19) is still ongoing with the omicron variant. Low-cost, effective treatments are still needed, particularly in low-to-middle-income countries. This study assessed the safety and efficacy of TD0068, an herbal medicine developed from mainly garlic, for patients with non-severe COVID-19. Methods This is a phase-II, double-blind, randomized controlled trial to compare oral capsule TD0068 and placebo in adults aged 18-65 years with non-severe COVID-19 between September and October 2021. The efficacy outcomes measured included daily cycle threshold (Ct) value from the time of the initial reverse transcription-polymerase chain reaction (RT-PCR) test, time to viral clearance, daily symptom severity score from 15 symptoms of interest, time to symptom resolution, and progression to severe/critical COVID-19. Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Results Sixty patients were randomized (31 received TD0068, and 29 received a placebo). The two groups were balanced in baseline characteristics: mean age was 39 years, and female was predominant (66%). Daily Ct value (median on days 3, 5, 7, and 9 was 25.7, 30.8, 35.4, and 37.6 in the TD0068 group, and 26.4, 31.2, 36.0, and 37.4 in the placebo group, respectively) and time to viral clearance (median: 10 vs. 11 days in TD0068 and placebo groups) were similar between groups. Daily symptom severity score (median on days 3, 5, 7, and 9 was 2, 2, 1, and 0 in the TD0068 group, and 3, 2, 1, and 1 in the placebo group), and time to symptom resolution (median: seven vs. nine days, respectively) were also comparable between groups. No SAE occurred in the study. Conclusions TD0068 is safe but does not show an effect for non-severe COVID-19 patients. Further research is needed to explore the potential benefits of garlic in other forms or dosages for the treatment of COVID-19.
背景 2019 冠状病毒病（COVID - 19）仍在因奥密克戎变异株而持续流行。仍需要低成本、有效的治疗方法，尤其是在低收入和中等收入国家。本研究评估了主要由大蒜研制而成的草药 TD0068 对非重症 COVID - 19 患者的安全性和有效性。方法 这是一项 II 期双盲随机对照试验，于 2021 年 9 月至 10 月期间，比较 18 - 65 岁非重症 COVID - 19 成人患者口服 TD0068 胶囊与安慰剂的效果。所测量的疗效指标包括初次逆转录 - 聚合酶链反应（RT - PCR）检测时的每日循环阈值（Ct）值、病毒清除时间、15 项感兴趣症状的每日症状严重程度评分、症状缓解时间以及进展为重症/危重症 COVID - 19 的情况。安全性指标包括不良事件（AE）和严重不良事件（SAE）。结果 60 名患者被随机分组（31 人接受 TD0068，29 人接受安慰剂）。两组基线特征均衡：平均年龄为 39 岁，女性占多数（66%）。两组间每日 Ct 值（TD0068 组第 3、5、7 和 9 天的中位数分别为 25.7、30.8、35.4 和 37.6，安慰剂组分别为 26.4、31.2、36.0 和 37.4）以及病毒清除时间（中位数：TD0068 组和安慰剂组分别为 10 天和 11 天）相似。两组间每日症状严重程度评分（TD0068 组第 3、5、7 和 9 天的中位数分别为 2、2、1 和 0，安慰剂组分别为 3、2、1 和 1）以及症状缓解时间（中位数：分别为 7 天和 9 天）也相当。研究中未发生严重不良事件。结论 TD0068 是安全的，但对非重症 COVID - 19 患者未显示出疗效。需要进一步研究探索大蒜其他形式或剂量在治疗 COVID - 19 方面的潜在益处。
