Efficacy and safety of a novel antiviral preparation in ICU-admitted patients with COVID-19: a phase III randomized controlled trial

Introduction Despite an increasing number of studies, there is as yet no efficient antiviral treatment developed for the disease. In this clinical trial, we examined the efficacy of a novel herbal antiviral preparation comprising Zataria multiflora Boiss, Glycyrrhiza glabra, Cinnamomum Vermont, Allium sativuml, and Syzygium aromaticum in critically ill patients with COVID-19 patients. Methods A total number of 120 ICU-admitted patients requiring pulmonary support with a diagnosis of COVID-19 pneumonia were recruited to the trial. Participants were equally randomized to receive either the novel antiviral preparation sublingually, for up to two consecutive weeks or till discharge, or normal saline as the matching placebo. Clinical and laboratory parameters as well as survival rates were compared between the two groups at the study end. Results The cumulative incidence of death throughout the study period was 8.33% in the medication group and 60% in the placebo group (risk ratio: 0.14; 95% confidence interval [CI], 0.05 to 0.32; P<0.001). Survival rates were significantly higher in the treatment group. Additionally, on day 7, several laboratory factors including white blood cells (WBCs) count, C-reactive protein (CRP), and SpO2 were improved in patients treated with the novel antiviral preparation compared with the placebo group. Conclusion The novel antiviral preparation tested in this trial significantly improved the survival rate and reduced mortality in critically ill patients with COVID-19. Thus, this preparation might be suggested as a potentially promising COVID-19 treatment. Funded by Shimi Teb Salamat Co., Shiraz, Iran, and registered on the Iranian registry of clinical trials (registration No. IRCT20200509047373N2).