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

Sponsor
NeuroBo Pharmaceuticals Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04603924
Collaborator
(none)
436
Enrollment
9
Locations
2
Arms
25.8
Anticipated Duration (Months)
48.4
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
436 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients
Actual Study Start Date :
Oct 7, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANA001

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.

Drug: Niclosamide
Niclosamide is an antihelmintic with in-vitro antiviral activity
Other Names:
  • ANA001

    		•
    Placebo Comparator: Matching Placebo

    Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.

    Drug: Placebo
    Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability of ANA001 as measured by the incidence of treatment emergent adverse events (TEAE's) (Part 1 and Part 2) [Randomization to Day 28]

      Incidence of treatment emergent adverse events (TEAE's)

    2. Efficacy as measured by median time to hospital discharge (Part 2) [Randomization to Day 60]

      Median time to hospital discharge

    Secondary Outcome Measures

    1. Efficacy as measured by median time to hospital discharge (Part 1) [Randomization to Day 60]

      Median time to hospital discharge

    2. Pharmacokinetics (PK) of ANA001 as measured by plasma concentrations (Part 1) [Day 1, 2, 3 or 4]

      Plasma concentrations of ANA001

    3. Efficacy of ANA001 as measured by mean change from baseline in the National Early Warning Score (NEWS 2) (Part 2) [Day 15]

      Mean change from baseline in National Early Warning Score (NEWS 2) score

    4. Efficacy of ANA001 as measured by mean number of days on rescue therapy (Part 2) [Within 15 days after enrollment]

      Mean number of days on rescue therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Provide written informed consent prior to performing study procedures

    2. Hospitalized.

    3. Male or female ≥18 years of age

    4. Positive for severe acute respiratory syndrome coronavirus 2

    5. Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath

    6. At least 1 of the following: respiratory rate (RR) ≥20 breaths per minute, room air oxygen saturation (SpO2) <98%, requirement for supplemental oxygen, heart rate (HR) ≥90 beats per minute, or temperature >38.3°C

    7. Women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through Day 30

    Key Exclusion Criteria:

    1. Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)

    2. Patient is not anticipated to survive >48 hours OR is under palliative care

    3. Evidence of critical illness, defined by at least 1 of the following:

    • Respiratory failure requiring at least 1 of the following:

    1. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula

    2. Noninvasive positive pressure ventilation (NIPVV), OR

    3. Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure

    • Shock (defined by systolic blood pressure (BP) <90 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR

    • Multi-organ dysfunction/failure

    1. Severe central nervous system (CNS) conditions

    2. Chronic kidney disease requiring dialysis

    3. Known allergy to the study drug or salicylate containing medications.

    4. Suspected and/or confirmed pregnancy or breastfeeding

    5. Current or planned participation in any other clinical trial of a treatment being developed under a US investigational new drug (IND) or emergency use authorization (EUA).

    6. Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helen Keller Hospital Sheffield Alabama United States 35660
    2 University of California, Irvine Irvine California United States 92697
    3 Baptist Health Research Institute Jacksonville Florida United States 32207
    4 AdventHealth Tampa Tampa Florida United States 33613
    5 University of Missouri Health Care Columbia Missouri United States 65212
    6 Caroline Institute for Clinical Research Fayetteville North Carolina United States 28303
    7 Memorial Hermann Memorial City Medical Center Houston Texas United States 77024
    8 Memorial Hermann Southeast Hospital Houston Texas United States 77089
    9 Providence Regional Medical Center Everett Everett Washington United States 92801

    Sponsors and Collaborators

    • NeuroBo Pharmaceuticals Inc.

    Investigators

    • Study Director: Doug Rank, MD, NeuroBo Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NeuroBo Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT04603924
    Other Study ID Numbers:
    • ANA001-001
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Apr 26, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NeuroBo Pharmaceuticals Inc.
    Corona Virus Disease (COVID-19)
    Niclosamide
    Antiviral
    Immunomodulator
    Oral Niclosamide
    Infection
    Acute Respiratory Distress Syndrome (ARDS)
    Cytokine dysregulation
    Virus
    Viral
    anthelmintic
    anti-inflammatory
    bronchodilator
    antineoplastic
    ANA001
    Moderate COVID-19
    ARDS
    Acute Respiratory Distress Syndrome
    Hospitalized COVID-19
    Additional relevant MeSH terms:
    COVID-19
    Niclosamide

    Study Results

    No Results Posted as of Apr 26, 2022