Ivermectin shows clinical benefits in mild to moderate COVID19: a randomized controlled double-blind, dose-response study in Lagos
Prof O E Babalola, C O Bode, A A Ajayi, F M Alakaloko, I E Akase, E Otrofanowei, O B Salu, W L Adeyemo, A O Ademuyiwa, S Omilabu
QJM: An International Journal of Medicine, doi:10.1093/qjmed/hcab035
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 Â 10 3 /ml. The platelet count increase was inversely correlated to DTN (r ¼ -0.52, P ¼ 0.005). No SAE was reported.
Conflict of interest. None declared.
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'abstract': '<jats:title>Summary</jats:title>\n'
' <jats:sec>\n'
' <jats:title>Introduction</jats:title>\n'
' <jats:p>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.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Methods</jats:title>\n'
' <jats:p>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\u2009mg regime, (B) IV 12\u2009mg regime '
'(given Q84 h for 2\u2009weeks) (C, control) Lopinavir/Ritonavir. All groups plus standard of '
'Care.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Results</jats:title>\n'
' <jats:p>The Days to COVID negativity (DTN) was significantly and dose '
'dependently reduced by IV (P\u2009=\u20090.0066). The DTN for Control were, = 9.1+/–5.2, for '
'A 6.0 +/– 2.9 and for B 4.6 +/–3.2. Two way repeated measures ANOVA of ranked COVID 19 +/– '
'scores at 0, 84, 168 and252h showed a significant IV treatment effect (P\u2009=\u20090.035) '
'and time effect (P\u2009&lt;\u20090.0001). IV also tended to increase SPO2% compared to '
'controls, P\u2009=\u20090.073, 95% CI—0.39 to 2.59 and increased platelet count compared to C '
'(P\u2009=\u20090.037) 95%CI 5.55—162.55\u2009×\u2009103/ml. The platelet count increase was '
'inversely correlated to DTN (r = –0.52, P\u2009=\u20090.005). No SAE was reported.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Conclusions</jats:title>\n'
' <jats:p>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.</jats:p>\n'
' </jats:sec>',
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