Study Stopped
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
Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedFebruary 21, 2022
February 1, 2021
Same day
June 16, 2020
February 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Niclosamide
EXPERIMENTALContinued SOC therapy together with Niclosamide tablets for 14 days
Placebo
PLACEBO COMPARATORContinued SOC therapy together with placebo tablets matching niclosamide
Interventions
Continued SOC therapy together with niclosamide TID for 14 days
Continued SOC therapy together with placebo tablets matching niclosamide for 14 days
Eligibility Criteria
You may qualify if:
- 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
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
June 16, 2020
First Posted
June 18, 2020
Study Start
January 20, 2022
Primary Completion
January 20, 2022
Study Completion
January 20, 2022
Last Updated
February 21, 2022
Record last verified: 2021-02