Favipiravir and/or nitazoxanide: a randomized, double-blind, 2x2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE)



Smith, Tania, Hoyo-Vadillo, Carlos, Adom, Akosua Agyeman, Favari-Perozzi, Liliana, Gastine, Silke, Dehbi, Hakim-Moulay, Villegas-Lara, Beatriz, Mateos, Eduardo, Gonzalez, Yessica Sara Perez, Navarro-Gualito, Maria D
et al (show 10 more authors) (2022) Favipiravir and/or nitazoxanide: a randomized, double-blind, 2x2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE). TRIALS, 23 (1). 583-.

Access the full-text of this item by clicking on the Open Access link.
[img] Text
Favipiravir andor nitazoxanide a randomized, double-blind, 2 - Published version

Download (0B)
[img] PDF
Favipiravir andor nitazoxanide a randomized, double-blind, 2 - Unspecified

Download (0B)
[img] PDF
Favipiravir andor nitazoxanide a randomized, double-blind, 2 - Unspecified

Download (0B)

Abstract

<h4>Background</h4>The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with the first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with a better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.<h4>Methods</h4>Trial design: Phase IIA randomised, double-blind, 2 × 2 design, placebo-controlled, interventional trial.<h4>Randomisation</h4>Participants will be randomised 1:1 by stratification, with the following factors: gender, obesity, symptomatic or asymptomatic, current smoking status presence or absence of comorbidity, and if the participant has or has not been vaccinated.<h4>Blinding</h4>Participants and investigators will both be blinded to treatment allocation (double-blind).<h4>Discussion</h4>We propose to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and patients treated at the Mexican Social Security Institute (IMSS) facilities. Participants with or without symptomatic COVID-19 or who tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate. If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease.<h4>Trial registration</h4>ClinicalTrials.gov NCT04918927 . Registered on June 9, 2021.

Item Type: Article
Uncontrolled Keywords: COVID-19, Antivirals, Combination therapy, Early treatment, 2x2 design, Favipiravir, Nitazoxanide, Placebo-controlled trial, Protocol, Randomised controlled trial
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 25 Oct 2022 15:07
Last Modified: 18 Jan 2023 19:49
DOI: 10.1186/s13063-022-06533-0
Open Access URL: https://trialsjournal.biomedcentral.com/articles/1...
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3165754