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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 2, 3 or 4

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

Skin rash

Vomiting

100%

80%

60%

40%

20%

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

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