Clinical trial NCT04603924: Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
Official title: A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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
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.

Primary outcomes:
measure: Number of Subjects Experiencing TEAEs
timeFrame: Randomization to Day 60
measure: Number of Subjects Experiencing TESAEs
timeFrame: Randomization to Day 60
Secondary outcomes:
measure: Median Time to Hospital Discharge
timeFrame: Randomization to Day 60
measure: Median Time to 2-point Improvement WHO Clinical Improvement Scale
timeFrame: Randomization to Day 60
measure: Median Time to Resolution of COVID-19 Symptoms
timeFrame: Randomization to Day 60
measure: Median Time to Time-to-Viral Load Undetectable
timeFrame: Randomization to Day 60
measure: AUC 0-t (h*ng/mL)
timeFrame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
measure: Cmax (ng/mL)
timeFrame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
measure: Tmax (h)
timeFrame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Fayetteville
country: United States
facility: Caroline Institute for Clinical Research
state: North Carolina
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
Study officials:
affiliation: NeuroBo Pharmaceuticals
name: Doug Rank, MD
role: STUDY_DIRECTOR
References: