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).
Index: COVID-19, Clinical status, Hydroxychloroquine, Levamisole, SARS-CoV2