U.S. flag

An official website of the United States government

Skip to main page content
Withdrawn
Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.

Niclosamide In Moderate COVID-19

ClinicalTrials.gov ID NCT04436458
Sponsor Entero Therapeutics
Information provided by Entero Therapeutics (Responsible Party)
Last Update Posted 2022-02-21
Bookmark

Study Overview

Brief Summary
This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.
Official Title
Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms
Conditions
COVID
Intervention / Treatment
  • Drug: Niclosamide Oral Tablet
  • Drug: Placebo
  • Drug: Niclosamide Oral Tablet
  • Drug: Placebo
Other Study ID Numbers
  • FW-COV-002
Study Start (Actual)
2022-01-20
Primary Completion (Actual)
2022-01-20
Study Completion (Actual)
2022-01-20
Enrollment (Actual)
0
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

No location data

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Patients hospitalized for treatment 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.
  • Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day.
  • SARS-CoV-2 infection confirmed by RT-PCR 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.
Show less
Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Niclosamide
Continued SOC therapy together with Niclosamide tablets for 14 days
Intervention/Treatment Drug: Niclosamide Oral Tablet
  • Continued SOC therapy together with niclosamide TID for 14 days

Participant Group/Arm Placebo Comparator: Placebo
Continued SOC therapy together with placebo tablets matching niclosamide
Intervention/Treatment Drug: Placebo
  • Continued SOC therapy together with placebo tablets matching niclosamide for 14 days

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group From Day 1 to 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Entero Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-06-16
First Submitted that Met QC Criteria
2020-06-17
First Posted
2020-06-18
Study Record Updates
Last Update Submitted that met QC Criteria
2022-02-04
Last Update Posted
2022-02-21
Last Verified
2021-02

More Information

/

Additional Relevant MeSH Terms