Background 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. Methods 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. Results 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). Conclusion 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. Trial registration The trial was registered as IRCT20190810044500N7 (19/09/2020).
【저자키워드】 COVID-19, SARS-CoV2, Hydroxychloroquine, clinical status, Levamisole, 【초록키워드】 Efficacy, Trial, oxygen, cough, Moderate COVID-19, Randomized, management, Fever, Dyspnea, Patient, Mild, Placebo, Follow-up, distribution, Combination, COVID-19 patient, double-blind, Standard of care, significant difference, no significant difference, Controlled clinical trial, clinical benefit, Registered, MOST, immunomodulatory effect, men, Randomly, IMPROVE, Course, Result, enrolled, shown, evaluate, significantly, the disease, receiving, was performed, assigned, two group, interval, study participant, receive, in both group, patients with COVID-19, the placebo group, 【제목키워드】 Treatment, Patient, clinical presentation, double-blind, randomized, controlled trial,