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Anti-viral

Niclosamide for COVID-19

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
Provide written informed consent prior to performing study procedures
Hospitalized.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 3 or 4
Awards & highlights

Study Summary

This trial is studying a potential treatment for moderate and severe COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are male or female, at least 18 years of age.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial being conducted across North America?

"There are 8 sites running this study, such as University of Missouri Health Care in Columbia, Therapeutic Concepts, PA in Houston, and University of California, Irvine in Irvine."

Answered by AI

What does the current literature say about Niclosamide's efficacy?

"There are six clinical trials studying Niclosamide with two in Phase 3 currently. Phase 3 trials are the last step before Niclosamide can be approved for medical use. The majority of these trials are based in Palo Alto, California, but Niclosamide studies are being conducted at 50 different research sites."

Answered by AI

What medical goal are we trying to achieve with this experiment?

"This clinical trial's primary goal is to assess the safety and tolerability of ANA001, as measured by the incidence of treatment emergent adverse events (TEAEs). Secondary objectives include efficacy, as measured by the median time to hospital discharge, the mean number of days on rescue therapy, and the mean change from baseline in the National Early Warning Score (NEWS 2)."

Answered by AI

Are there any openings in this experimental program for new participants?

"That is accurate. The website clinicaltrials.gov has information indicating that the trial is still seeking participants. The trial was established on October 7th, 2020 and the listing was edited most recently on April 22nd, 2022. The study needs 436 patients from 8 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Helen Keller Hospital
Therapeutic Concepts, PA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
2020. "Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04603924.
~27 spots leftby Apr 2025
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