Ivermectin shows clinical benefits in mild to moderate COVID19: A randomized controlled double-blind, dose-response study in Lagos

Abstract

Introduction: In vitro studies have shown the efficacy of Ivermectin (IV) to inhibit the SARS—CoV-2 viral replication, but questions remained as to in-vivo applications. We set out to explore the efficacy and safety of Ivermectin in persons infected with COVID19. Methods: We conducted a translational proof of concept randomized, double blind placebo controlled, dose response and parallel group study of IV efficacy in RT—polymerase chain reaction proven COVID 19 positive patients. Sixty-two patients were randomized to three treatment groups. (A) IV 6 mg regime, (B) IV 12 mg regime (given Q84 h for 2 weeks) (C, control) Lopinavir/Ritonavir. All groups plus standard of Care. Results: The Days to COVID negativity (DTN) was significantly and dose dependently reduced by IV (P ¼ 0.0066). The DTN for Control were, ¼ 9.1þ/–5.2, for A 6.0 þ/– 2.9 and for B 4.6 þ/–3.2. Two way repeated measures ANOVA of ranked COVID 19 þ/– scores at 0, 84, 168 and252h showed a significant IV treatment effect (P ¼ 0.035) and time effect (P < 0.0001). IV also tended to increase SPO2% compared to controls, P ¼ 0.073, 95% CI—0.39 to 2.59 and increased platelet count compared to C (P ¼ 0.037) 95%CI 5.55—162.55 103 /ml. The platelet count increase was inversely correlated to DTN (r ¼ –0.52, P ¼ 0.005). No SAE was reported.Conclusions: 12mg IV regime given twice a week may have superior efficacy over 6mg IV given twice a week, and certainly over the non IV arm of the study. IV should be considered for use in clinical management of SARS-COV2, and may find applications in prophylaxis in high risk areas.