Niclosamide in COVID-19

A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19

This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Drug: Niclosamide Oral Tablet; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.

Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.

• Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
• SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
• Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

• At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
• Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Matching placebo tablets 3 times daily for 14 days
EXPERIMENTAL: Niclosamide	Drug: Niclosamide Oral Tablet; Niclosamide tablets 400 mg 3 times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	From Day 1 to 6 weeks
TEAE	Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation	From Day 1 to 6 weeks
SAEs	Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)	From Day 1 to end of study
Safety laboratory	Change in safety laboratory tests from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided	From Day 1 to 6 weeks
Blood pressure	Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
fecal RNA virus clearance	time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)	From Day 1 to 6 weeks
Body temperature	Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
Heart rate	Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
SaO2	Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
ECG	Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks	From Day 1 to 6 weeks

Collaborators and Investigators

• Sponsor: First Wave Bio, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2022
• Primary Completion (ACTUAL): January 20, 2022
• Study Completion (ACTUAL): January 20, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Niclosamide
• Other Study ID Numbers: FW-COV-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No