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

NCT04603924 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ANA001-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

Brief Summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Experiencing TEAEs

  Incidence of Treatment Emergent Adverse Events (TEAEs)

  Randomization to Day 60

• Number of Subjects Experiencing TESAEs

  Incidence of Treatment Emergent Serious Adverse Events (TESAEs)

  Randomization to Day 60

Secondary Outcomes (7)

• Median Time to Hospital Discharge

  Randomization to Day 60

• Median Time to 2-point Improvement WHO Clinical Improvement Scale

  Randomization to Day 60

• Median Time to Resolution of COVID-19 Symptoms

  Randomization to Day 60

• Median Time to Time-to-Viral Load Undetectable

  Randomization to Day 60

• AUC 0-t (h*ng/mL)

  Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.

Study Arms (2)

ANA001

EXPERIMENTAL

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

Matching Placebo

PLACEBO COMPARATOR

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

Interventions

Niclosamide DRUG

Niclosamide is an antihelmintic with in-vitro antiviral activity

Also known as: ANA001

ANA001

Placebo DRUG

Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Also known as: Matching Placebo to ANA001

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to performing study procedures
• Hospitalized.
• Male or female ≥18 years of age
• Positive for severe acute respiratory syndrome coronavirus 2
• 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
• 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
• 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

You may not qualify if:

• Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
• Patient is not anticipated to survive \>48 hours OR is under palliative care
• Evidence of critical illness, defined by at least 1 of the following:
• Respiratory failure requiring at least 1 of the following:
• Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
• Noninvasive positive pressure ventilation (NIPVV), OR
• 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
• Severe central nervous system (CNS) conditions
• Chronic kidney disease requiring dialysis
• Known allergy to the study drug or salicylate containing medications.
• Suspected and/or confirmed pregnancy or breastfeeding
• 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).
• Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.

Sponsors & Collaborators

• NeuroBo Pharmaceuticals Inc.: lead

Study Sites (8)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Caroline Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 92801, United States

Location

MeSH Terms

Conditions

COVID-19; Infections; Respiratory Distress Syndrome; Virus Diseases

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Results Point of Contact

• Title: Sr. Vice President Clinical Operations
• Organization: Robert Homolka

bob.homolka@neurobopharma.com

8572991035

Study Officials

• Doug Rank, MD

  NeuroBo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 27, 2020
• Study Start: October 7, 2020
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)