Effects of Shallomin with Lopinavir/Ritonavir on clinical outcomes and mortality in COVID-19 patients: A randomised double-blind clinical trial study

Introduction: Given the apparent life-threatening nature of coronavirus disease-2019 (COVID-19), finding an effective treatment is under investigations.Methods: Here, we investigated effects of oral Shallomin syrup and its respiratory spray (co IranAmin) as a formulated ethylene acetate fraction of Persian shallot with confirmed antiviral effect as complementary treatment on clinical outcomes on confirmed COVID-19 patients that were under Lopinavir/Ritonavir therapy. This randomised double-blind clinical trial study was performed on diagnosed patients with COVID-19 with Ethical Code: IR.DUMS.REC.1399.014 by the date 7 July 2020 and clinical trial registration code: IRCT20200725048199N1 by the date 11 August 2020. Patients in the control group (n = 72) received the approved treatment protocol (Lopinavir/Ritonavir) while those in the intervention group (n = 71) were treated with Shallomin oral syrup and its respiratory spray in addition to the indicated authorised treatment protocol. Clinical status, blood oxygen saturation (SaO2), days of hospitalisation, and mortality of treated patients were recorded and compared. Results: There was a meaningful difference between the two groups regarding fever, epigastric pain, and average days of admission (decreasing from 11.17 to 7.41 days; P < 0.001). Average SaO2 levels were improved, and the rate of death was decreased in the intervention group (n = 3; 4.22%) compared to the control group (n = 10; 13.88%). Conclusions: It seems treatment with oral Shallomin syrup and its respiratory spray (co IranAmin) showed remarkable contribution to the recovery of COVID-19 induced symptoms, improved blood oxygen saturation level, and significant shortening of hospital stay in COVID-19 confirmed patients under Lopinavir/Ritonavir therapy.