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0 0.5 1 1.5 2+ Ventilation -152% Improvement Relative Risk Progression -4% Viral decay rate 66% primary Krolewiecki et al. NCT004381884 Ivermectin RCT EARLY Is early treatment with ivermectin beneficial for COVID-19? RCT 41 patients in Argentina Improved viral load with ivermectin (not stat. sig., p=0.086) Krolewiecki et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100959 Favors ivermectin Favors control

Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial

Krolewiecki et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100959, NCT004381884 (history)
Krolewiecki et al., Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial, EClinicalMedicine, doi:10.1016/j.eclinm.2021.100959, NCT004381884
Jun 2021   Source   PDF  
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Proof of concept RCT with 30 ivermectin patients and 15 control patients, showing a concentration dependent antiviral activity, but no significant difference in clinical outcomes. There was no significant difference in viral load reduction between groups overall, but a significant difference was found in patients with higher median plasma ivermectin levels (72% vs. 42%, p=0.004). Mean ivermectin plasma concentration levels correlated with viral decay rate (r=0.47, p=0.02). The change in viral load is provided for the <160ng/mL and >160ng/mL groups, but not the overall treatment group. The corrigendum provides individual viral decay rates for computing the overall treatment group viral decay rate. Authors published a corrigendum: [].
This is the 27th of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.
This is the 57th of 97 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion).
risk of mechanical ventilation, 151.9% higher, RR 2.52, p = 1.00, treatment 1 of 27 (3.7%), control 0 of 14 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of progression, 3.7% higher, RR 1.04, p = 1.00, treatment 2 of 27 (7.4%), control 1 of 14 (7.1%).
viral decay rate, RR 0.34, p = 0.09, treatment 20, control 14, relative mean viral decay rate (corrigendum table 2, all treatment patients vs. all control patients), primary outcome.
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Krolewiecki et al., 18 Jun 2021, Randomized Controlled Trial, Argentina, peer-reviewed, 23 authors, average treatment delay 3.5 days, dosage 600μg/kg days 1-5, trial NCT004381884 (history).
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Abstract: EClinicalMedicine 37 (2021) 100959 Contents lists available at ScienceDirect EClinicalMedicine journal homepage: Research paper Antiviral effect of high-dose ivermectin in adults with COVID-19: A proofof-concept randomized trial n Lifschitzb, Matías Moragasc, Marina Travaciod, Alejandro Krolewieckia,*, Adria e n Solarig, Marcelo A. Tinellih, Rube n O. Ciminoa, Ricardo Valentini , Daniel F. Alonsof, Rube b  ndezc, , Pedro E. Fleitasa, Laura Ceballosb, Marcelo Golembac, Florencia Ferna Luis Alvarez e g e i s Baeck , Javier Farina , ndez de Oliveira , German Astudillo , Ine Diego Ferna Georgina A. Cardamaf, Andrea Manganoc, Eduardo Spitzerh,1, Silvia Goldj,1, Carlos Lanusseb,1 a n, Universidad Nacional de Salta, Alvarado 751 (4530), Ora n, Instituto de Investigaciones de Enfermedades Tropicales (IIET-CONICET), Sede Regional Ora Argentina b Laboratorio de Farmacología, CONICET-CICPBA-UNCPBA, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Cenn Veterinaria de Tandil (CIVETAN), Tandil, Argentina tro de Investigacio c Unidad de Virología y Epidemiología Molecular, Hospital de Pediatría ''Prof. Dr. Juan P. Garrahan''-CONICET, Ciudad de Buenos Aires, Argentina d  nica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Buenos Aires, Argentina Catedra de Química General e Inorga e n Medica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina Departamento de Medicina, Centro de Educacio f gicos, Departamento de Ciencia y Tecnología, Universidad Nacional Centro de Oncología Molecular y Traslacional (COMTra) y Plataforma de Servicios Biotecnolo de Quilmes, Buenos Aires, Argentina g ~ iz, Buenos Aires, Argentina Hospital Francisco J. Mun h Laboratorio Elea/Phoenix, Los Polvorines, Argentina i ~ uelas, Argentina Servicio de Infectología, Hospital Cuenca Alta, Can j n Mundo Sano, Buenos Aires, Argentina Fundacio A R T I C L E I N F O Article History: Received 22 February 2021 Revised 17 May 2021 Accepted 25 May 2021 Available online 18 June 2021 A B S T R A C T Background: There are limited antiviral options for the treatment of patients with COVID-19. Ivermectin (IVM), a macrocyclic lactone with a wide anti-parasitary spectrum, has shown potent activity against SARSCoV-2 in vitro. This study aimed at assessing the antiviral effect of IVM on viral load of respiratory secretions and its relationship with drug concentrations in plasma. Methods: Proof-of-concept, pilot, randomized, controlled, outcome-assessor blinded trial to evaluate antiviral activity of high-dose IVM in 45 COVID-19 hospitalized patients randomized in a 2:1 ratio to standard of care plus oral IVM at 0¢6 mg/kg/day for 5 days versus standard of care in 4 hospitals in Argentina. Eligible patients were adults with RT-PCR confirmed SARS-CoV-2 infection within 5 days of symptoms onset. The primary endpoint was the difference in viral load in respiratory secretions between baseline and day-5, by quantitative RT-PCR. Concentrations of IVM in plasma were measured. Study registered at NCT04381884. Findings: 45 participants were recruited (30 to IVM and 15 controls) between May 18 and September 9, 2020. There was no difference in viral load reduction between groups but a significant difference was found in patients with higher median plasma IVM levels (72% IQR 5977) versus untreated controls (42% IQR 3173) (p = 0¢004). Mean..
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