Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study
Small RCT with 23 nitazoxanide and 13 control patients showing significantly more patients achieved over 35% reduction in viral load from baseline.
NCT04463264 (history).
relative mean improvement in Ct, 26.5% better, RR 0.74, p = 0.36, treatment 23, control 13.
|
risk of viral load reduction < 35% at day 7, 38.3% lower, RR 0.62, p = 0.08, treatment 12 of 23 (52.2%), control 11 of 13 (84.6%), NNT 3.1.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Silva et al., 5 Mar 2021, Single Blind Randomized Controlled Trial, Argentina, preprint, 11 authors, trial
NCT04463264 (history).
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.03.03.21252509; this version posted March 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-ND 4.0 International license .
Title: Efficacy of Nitazoxanide in reducing the viral load in COVID-19
patients.
Randomized, placebo-controlled, single-blinded, parallel-group, pilot study.
Authors: Marcelo Silva1, Andrés Espejo1, María L Pereyra1, Martín Lynch1, Marcos Thompson1,
Hernán Taconelli2, Patricia Baré3, Matías J Pereson3, Marcelo Garbini4, Pablo Crucci4, Diego
Enriquez4.
Affiliations: 1Unidad de Hepatología y Trasplante Hepático, Hospital Universitario Austral, Pilar,
Argentina. 2Sanatorio Nuestra Señora del Pilar, Ciudadela, Argentina. 3IIHEMA, IMEX-CONICET,
Academia Nacional de Medicina. 4Departamento de Investigación Clínica, Laboratorios Roemmers.
Corresponding author:
Prof. Marcelo Silva, MD. Director de la Unidad de Hepatología y Trasplante Hepático, Hospital
Universitario Austral, Pilar, Argentina Av. J. D. Perón 1500 (1629). Derqui, Provincia de Buenos
Aires, Argentina.
e-mail: msilva@cas.austral.edu.ar
Abstract:
The fast spread of COVID-19 has overcrowded Public Health Systems facilities in major countries
due to the large number of seriously ill patients, particularly those requiring admission to intensive
care units.
Reducing viral load, along with other recommended epidemiological measures, such as social
distancing and home confinement, can in time significantly help to reduce the infection R0 (Basic
Reproductive Rate) and then mitigate disease burden.
Early negativization or otherwise reduction of the viral load can potentially diminish disease severity,
resulting in a better-controlled public health response, avoiding collapse of healthcare systems.
Nitazoxanide, a widely used thiazolide approved by the FDA as an antiparasitic drug, also approved
in Brazil for Norovirus and Rotavirus treatments, has an excellent safety record for a variety of
indications. Nitazoxanide exhibits activity in vitro against MERS-CoV and other coronaviruses; and
a specific antiviral effect (in micro molar doses) against SARS-CoV-2.
The objective of this study was to evaluate the efficacy and safety of Nitazoxanide in reducing the
SARS-COV 2 viral load within 7 days of treatment in respiratory samples from COVID-19-infected
patients with mild to moderate disease, compared to placebo.
An interim analysis showed that the ratio of patients with a viral load reduction ≥ 35% from baseline
up to day 7 of treatment was significantly greater for Nitazoxanide compared to placebo (47.8% vs.
15.4%; Δ 34.6%; 95% CI: 64.7; 4.6: p = 0.037).
1
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2021.03.03.21252509; this version posted March 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-ND 4.0 International license .
Key words: Nitazoxanide, COVID-19, viral load, antiviral, SARS-Cov-2.
KEY POINTS
State of the Art:
Different studies conclude that viral load (VL) would correlate with morbidity, mortality and
contagiousness of..
Please send us corrections, updates, or comments. 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