Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

Official Title

A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients

Details

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.

Keywords

COVID-19 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

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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:
  4. Respiratory failure requiring at least 1 of the following:
  5. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
  6. Noninvasive positive pressure ventilation (NIPVV), OR
  7. Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure
  8. Shock (defined by systolic blood pressure (BP) <90 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR
  9. Multi-organ dysfunction/failure
  10. Severe central nervous system (CNS) conditions
  11. Chronic kidney disease requiring dialysis
  12. Known allergy to the study drug or salicylate containing medications.
  13. Suspected and/or confirmed pregnancy or breastfeeding
  14. 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).
  15. Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Providence Regional Medical Center Everett accepting new patients
    Everett Washington 92801 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NeuroBo Pharmaceuticals Inc.
ID
NCT04603924
Phase
Phase 2/3 COVID-19 Research Study
Study Type
Interventional
Participants
Expecting 436 study participants
Last Updated