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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-02-16

Brief Summary

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Study of ANA001 in Moderate and Severe COVID-19 Patients

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ANA001

Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Group Type EXPERIMENTAL

Niclosamide

Intervention Type DRUG

Niclosamide is an antihelmintic with in-vitro antiviral activity

Matching Placebo

Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Interventions

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Niclosamide

Niclosamide is an antihelmintic with in-vitro antiviral activity

Intervention Type DRUG

Placebo

Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Intervention Type DRUG

Other Intervention Names

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ANA001 Matching Placebo to ANA001

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No