Amirreza Roostaei Firozabad1, Zohreh Akhoundi Meybodi2, Seyed Ruhollah Mousavinasab3, Adeleh Sahebnasagh4, Mohsen Gholinataj Jelodar5, Iman Karimzadeh6, Solomon Habtemariam7, Fatemeh Saghafi8. 1. Pharmaceutical Sciences Research Center, Student Research Committee, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran. 2. Infectious disease research center, Shahid Sadoughi hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. 3. Resident of Clinical Pharmacy, Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 4. Clinical Research Center, Department of Internal Medicine, School of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran. 5. Department of Internal Medicine, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. 6. Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 7. Pharmacognosy Research Laboratories and Herbal Analysis Services UK, University of Greenwich, Central Avenue, Chatham-Maritime, Kent, ME4 4TB, UK. 8. Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. f.saghafi@ssu.ac.ir.
Abstract
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).
RCT Entities:
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-19patients 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).
Authors: Christine Burkard; Monique H Verheije; Oliver Wicht; Sander I van Kasteren; Frank J van Kuppeveld; Bart L Haagmans; Lucas Pelkmans; Peter J M Rottier; Berend Jan Bosch; Cornelis A M de Haan Journal: PLoS Pathog Date: 2014-11-06 Impact factor: 6.823
Authors: Reinaldo B Bestetti; Rosemary Furlan-Daniel; Vinicius M R Silva Journal: Int J Environ Res Public Health Date: 2021-07-05 Impact factor: 3.390