Jacksonville, Florida 32207

  • 19

Purpose:

Study of ANA001 in Moderate and Severe COVID-19 Patients


Study summary:

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.


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


NCT ID:

NCT04603924


Primary Contact:

Study Director
Doug Rank, MD
NeuroBo Pharmaceuticals

Akash Bakshi
Phone: 1 650-263-1270
Email: akash@neurobopharma.com


Backup Contact:

Email: andrew@neurobopharma.com
Andrew Bartynski
Phone: 1 650-263-1270


Location Contact:

Jacksonville, Florida 32207
United States

Akash Bakshi
Phone: 650-263-1270
Email: akash@neurobopharma.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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