NCT04858425

Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Entero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Niclosamide	Niclosamide tablets 400 mg 3 times daily for 14 days
DRUG	Placebo	Matched placebo tablets 400 mg 3 times daily for 14 days

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-06-04
• Completion: 2023-09-10
• First posted: 2021-04-26
• Last updated: 2024-10-08
• Results posted: 2024-07-24

Locations

25 sites across 3 countries: United States, India, Ukraine

Regulatory

• FDA-regulated drug study