← Back to Search

Anti-viral

Niclosamide for Coronavirus

Phase 2 & 3
Waitlist Available
Research Sponsored by NeuroBo Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 3 or 4

Summary

This trial is testing an oral medication called niclosamide (ANA001) in patients with moderate and severe COVID-19 who are in the hospital. The goal is to see if it is safe and effective. Niclosamide works by stopping the virus from making more copies of itself, which could help reduce the severity of the disease. Niclosamide, an FDA-approved oral drug, has broad biological activity including anticancer, antibacterial, and antiviral properties.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 3 or 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 2, 3 or 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy as measured by median time to hospital discharge (Part 2)
Safety and Tolerability of ANA001 as measured by the incidence of treatment emergent adverse events (TEAE's) (Part 1 and Part 2)
Secondary study objectives
Efficacy as measured by median time to hospital discharge (Part 1)
Efficacy of ANA001 as measured by mean change from baseline in the National Early Warning Score (NEWS 2) (Part 2)
Efficacy of ANA001 as measured by mean number of days on rescue therapy (Part 2)
+1 more

Side effects data

From 2021 Phase 2 trial • 73 Patients • NCT04399356
21%
Nausea
9%
Skin rash
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Niclosamide- Experimental Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ANA001Experimental Treatment1 Intervention
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Group II: Matching PlaceboPlacebo Group1 Intervention
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niclosamide
2017
Completed Phase 3
~2280

Find a Location

Who is running the clinical trial?

NeuroBo Pharmaceuticals Inc.Lead Sponsor
14 Previous Clinical Trials
1,213 Total Patients Enrolled
Doug Rank, MDStudy DirectorNeuroBo Pharmaceuticals
1 Previous Clinical Trials
66 Total Patients Enrolled
~24 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top