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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603924
• Other study ID #: ANA001-001
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 7, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: December 2023
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Niclosamide
Niclosamide is an antihelmintic with in-vitro antiviral activity
• Placebo
Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Locations

Country	Name	City	State
United States	University of Missouri Health Care	Columbia	Missouri
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Caroline Institute for Clinical Research	Fayetteville	North Carolina
United States	Memorial Hermann Memorial City Medical Center	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	Helen Keller Hospital	Sheffield	Alabama
United States	AdventHealth Tampa	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of ANA001 as measured by the incidence of treatment emergent adverse events (TEAE's) (Part 1 and Part 2)	Incidence of treatment emergent adverse events (TEAE's)	Randomization to Day 28
Primary	Efficacy as measured by median time to hospital discharge (Part 2)	Median time to hospital discharge	Randomization to Day 60
Secondary	Efficacy as measured by median time to hospital discharge (Part 1)	Median time to hospital discharge	Randomization to Day 60
Secondary	Pharmacokinetics (PK) of ANA001 as measured by plasma concentrations (Part 1)	Plasma concentrations of ANA001	Day 1, 2, 3 or 4
Secondary	Efficacy of ANA001 as measured by mean change from baseline in the National Early Warning Score (NEWS 2) (Part 2)	Mean change from baseline in National Early Warning Score (NEWS 2) score	Day 15
Secondary	Efficacy of ANA001 as measured by mean number of days on rescue therapy (Part 2)	Mean number of days on rescue therapy	Within 15 days after enrollment