NCT04603924

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

Detailed description

This is a 2 part, Phase 2/3 multi-center, double blinded, placebo-controlled study to assess the safety, tolerability, and efficacy of oral niclosamide (ANA001) in moderate and severe hospitalized COVID-19 patients compared to placebo.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Niclosamide	Niclosamide is an antihelmintic with in-vitro antiviral activity
DRUG	Placebo	Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Timeline

• Start date: 2020-10-07
• Primary completion: 2022-02-16
• Completion: 2022-02-16
• First posted: 2020-10-27
• Last updated: 2025-05-15
• Results posted: 2025-05-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study