Pharmaceutical Sciences Research Center, Student Research Committee, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Infectious disease research center, Shahid Sadoughi hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
BMC Infect Dis. 2021 Mar 24;21(1):297. doi: 10.1186/s12879-021-05983-2.
Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. However, the exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease.
This prospective, double-blind, randomized controlled clinical trial was performed in adult patients with mild to moderate COVID-19 (room-air oxygen saturation > 94%) from late April 2020 to mid-August 2020. Patients were randomly assigned to receive a 3-day course of Levamisole or placebo in combination with routine standard of care.
With 25 patients in each arm, 50 patients with COVID-19 were enrolled in the study. Most of the study participants were men (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution when compared to the placebo group (P-value = 0.034 and 0.005, respectively). Moreover, there was significant differences between the two groups in dyspnea at follow-up intervals of 7 (P-value = 0.015) and 14 (P-value = 0.010) days after receiving the interventions. However, no significant difference in fever status was observed on days 1, 3, 7, and 14 in both groups (P-value > 0.05).
The results of the current study suggest that Levamisole may improve most of clinical status of patients with COVID-19. The patients receiving Levamisole had significantly better chance of clinical status including cough and dyspnea on day 14 when compared to the placebo. However, the effect-size of this finding has uncertain clinical importance.
The trial was registered as IRCT20190810044500N7 (19/09/2020).
左旋咪唑通过其免疫调节作用在 COVID-19 的治疗中显示出临床益处。然而，左旋咪唑对 COVID-19 患者临床状况的确切作用尚不清楚。我们旨在评估左旋咪唑对 COVID-19 患者疾病过程中临床状况的疗效。
这是一项前瞻性、双盲、随机对照临床试验，于 2020 年 4 月底至 8 月中旬在患有轻度至中度 COVID-19（室内空气氧饱和度>94%）的成年患者中进行。患者被随机分配接受为期 3 天的左旋咪唑或安慰剂联合常规标准治疗。
每组 25 例患者，共有 50 例 COVID-19 患者入组研究。大多数研究参与者为男性（60%）。在第 3 天和第 14 天，左旋咪唑组患者的咳嗽状况分布明显优于安慰剂组（P 值分别为 0.034 和 0.005）。此外，在接受干预后 7 天（P 值=0.015）和 14 天（P 值=0.010）的随访间隔，两组之间呼吸困难也存在显著差异。然而，两组在第 1、3、7 和 14 天的发热状况无显著差异（P 值>0.05）。
本研究结果表明，左旋咪唑可能改善 COVID-19 患者的大部分临床状况。与安慰剂组相比，接受左旋咪唑治疗的患者在第 14 天的咳嗽和呼吸困难临床状况明显更好。然而，这一发现的效应大小具有不确定的临床意义。
该试验于 2020 年 9 月 19 日在 IRCT20190810044500N7 注册（19/09/2020）。
