Protocol Description

Niclosamide is currently approved in the European Union to treat infection with cestodes, and it is included on the core list of minimum medicine needs for a basic healthcare system, as published in the most current World Health Organization (WHO) list of essential medicines (WHO 2020). Niclosamide’s activity as an anti-helminthic treatment result from direct action in the intestinal lumen where it disrupts parasite oxidative metabolism, killing parasites.

Niclosamide has been commercially available worldwide for more than 50 years as 500-mg tablets intended for use in pediatric and adult populations, at a dose of 2 g per adult or child over 6 years of age. No significant safety issues have been reported.

Drug repurposing/repositioning aimed at identifying new therapeutic applications for existing clinically approved drugs is a critical strategy to accelerate drug discovery for the COVID-19 pandemic. Multiple laboratories across the globe have now identified and validated Niclosamide to have potent antiviral activity against SARS-CoV-2.

Eligibility Criteria

You may be eligible to participate in this study if you meet the following criteria:

• Patients of any gender who are at least 18 years of age
• Part 1 only: Patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures
• Part 2 only: Patients with a primary diagnosis of COVID-19, with or without pneumonia
• Patients who had SARS-CoV-2 RNA presence in nasopharyngeal swab ≤5 days before randomization as confirmed by local or central laboratory

Clinical Trial Investigator

Dr. Jose David Suarez, Principal Investigator