Trial | NCT04603924  Report issue

Title

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
Study of ANA001 in Moderate and Severe COVID-19 Patients
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.
Study Started
Oct 07
2020
Primary Completion
Feb 16
2022
Study Completion
Feb 16
2022
Last Update
Dec 08
2023

Drug Niclosamide

Niclosamide is an antihelmintic with in-vitro antiviral activity

  • Other names: ANA001

Drug Placebo

Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

ANA001 Experimental

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.

Matching Placebo Placebo Comparator

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

Criteria 

Key Inclusion Criteria:

Provide written informed consent prior to performing study procedures
Hospitalized.
Male or female ≥18 years of age
Positive for severe acute respiratory syndrome coronavirus 2
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
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
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:

Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
Patient is not anticipated to survive >48 hours OR is under palliative care

Evidence of critical illness, defined by at least 1 of the following:

Respiratory failure requiring at least 1 of the following:

Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
Noninvasive positive pressure ventilation (NIPVV), OR
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
Severe central nervous system (CNS) conditions
Chronic kidney disease requiring dialysis
Known allergy to the study drug or salicylate containing medications.
Suspected and/or confirmed pregnancy or breastfeeding
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).
Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.
No Results Posted