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

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ClinicalTrials.gov Identifier: NCT04603924
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
NeuroBo Pharmaceuticals Inc.

Brief Summary:
Study of ANA001 in Moderate and Severe COVID-19 Patients

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Niclosamide Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 7, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022


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 Name: 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




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) [ Time Frame: Randomization to Day 28 ]
    Incidence of treatment emergent adverse events (TEAE's)

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


Secondary Outcome Measures :
  1. Efficacy as measured by median time to hospital discharge (Part 1) [ Time Frame: Randomization to Day 60 ]
    Median time to hospital discharge

  2. Pharmacokinetics (PK) of ANA001 as measured by plasma concentrations (Part 1) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Within 15 days after enrollment ]
    Mean number of days on rescue therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 2. Respiration Rate ≥30 breaths per minute, Heart Rate ≥125 beats per minute, or Oxygen Saturation (SpO2) ≤93% on ≤ 2 L/min nasal cannula oxygen 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 4. Severe central nervous system (CNS) conditions 5. Chronic kidney disease requiring dialysis 6. Known allergy to the study drug or salicylate containing medications. 7. Suspected and/or confirmed pregnancy or breastfeeding 8. 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).

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

      10. Patients who receive the severe acute respiratory syndrome coronavirus 2 vaccine


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603924


Contacts
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Contact: Akash Bakshi 1 650-263-1270 akash@neurobopharma.com
Contact: Andrew Bartynski 1 650-263-1270 andrew@neurobopharma.com

Locations
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United States, Alabama
Helen Keller Hospital Recruiting
Sheffield, Alabama, United States, 35660
Contact: Akash Bakshi    650-263-1270    akash@neurobopharma.com   
Contact: Andrew Bartynski    1650-263-1270    andrew@neurobopharma.com   
United States, Florida
Baptist Health Research Institute Recruiting
Jacksonville, Florida, United States, 32207
Contact: Akash Bakshi    650-263-1270    akash@neurobopharma.com   
Contact: Andrew Bartynski    1 650-263-1270    andrew@neurobopharma.com   
AdventHealth Tampa Recruiting
Tampa, Florida, United States, 33613
Contact: Akash Bakshi    650-263-1270    akash@neurobopharma.com   
Contact: Andrew Bartinski    650-263-1270    andrew@neurobopharma.com   
United States, Texas
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Contact: Akash Bakshi    650-263-1270    akash@neurobopharma.com   
Contact: Andrew Bartynski    1650-263-1270    andrew@neurobopharma.com   
Memorial Hermann Memorial City Medical Center Not yet recruiting
Houston, Texas, United States, 77024
Contact: Akash Bakshi    650-263-1270    akash@neurobopharma.com   
Contact: Andrew Bartinski    1650-263-1270    andrew@neurobopharma.com   
Sponsors and Collaborators
NeuroBo Pharmaceuticals Inc.
Investigators
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Study Director: Doug Rank, MD NeuroBo Pharmaceuticals
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Responsible Party: NeuroBo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04603924    
Other Study ID Numbers: ANA001-001
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents