Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial
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:
sciencedirect.com.
This is the
27th of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with
p=0.00000014.
This is the
57th of 99 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.
|
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Krolewiecki et al., 18 Jun 2021, Randomized Controlled Trial, Argentina, peer-reviewed, 23 authors, study period 18 May, 2020 - 9 September, 2020, average treatment delay 3.5 days, dosage 600μg/kg days 1-5, trial
NCT004381884 (history).
Abstract: EClinicalMedicine 37 (2021) 100959
Contents lists available at ScienceDirect
EClinicalMedicine
journal homepage: https://www.journals.elsevier.com/eclinicalmedicine
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 ClinicalTrials.gov:
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..
Please send us corrections, updates, or comments.
c19early involves the extraction of over 100,000 datapoints from
thousands of papers.
Community updates
help ensure high accuracy.
Vaccines and treatments are complementary. All practical, effective, and safe
means should be used based on risk/benefit analysis. No treatment, vaccine, or
intervention is 100% available and effective for all current and future
variants. We do not provide medical advice. Before taking any medication,
consult a qualified physician who can provide personalized advice and details
of risks and benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit
