Niclosamide in COVID-19

NCT04542434 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: FW-COV-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Niclosamide

EXPERIMENTAL

Drug: Niclosamide Oral Tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Niclosamide Oral Tablet DRUG

Niclosamide tablets 400 mg 3 times daily for 14 days

Niclosamide

Placebo DRUG

Matching placebo tablets 3 times daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Entero Therapeutics: lead

MeSH Terms

Conditions

COVID-19

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 9, 2020
• Study Start: January 20, 2022
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: February 21, 2022

Record last verified: 2021-12