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Keep this study
Lead
NeuroBo Pharmaceuticals Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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:
* 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.
Clareo Health | Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
