Niclosamide In Moderate COVID-19

Phase 2

Withdrawn

• Conditions: COVID
• Interventions: Drug: Niclosamide Oral Tablet; Drug: Placebo

• Registration Number: NCT04436458
• Lead Sponsor: Entero Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Status Verified: 2021-02
• Study Start: 2022-01-20
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niclosamide	Niclosamide Oral Tablet	Continued SOC therapy together with Niclosamide tablets for 14 days
Placebo	Placebo	Continued SOC therapy together with placebo tablets matching niclosamide

Primary Outcome Measures

Name	Time	Method
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