Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms

Entero Therapeutics0 sitesJanuary 20, 2022

ConditionsCOVID

InterventionsNiclosamide Oral Tablet Placebo

DrugsNiclosamide Oral Tablet Placebo

Overview

Phase: Phase 2
Intervention: Niclosamide Oral Tablet
Conditions: COVID
Sponsor: Entero Therapeutics
Primary Endpoint: 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
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 20, 2022

End Date

January 20, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Entero Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Niclosamide

Continued SOC therapy together with Niclosamide tablets for 14 days

Intervention: Niclosamide Oral Tablet

Placebo

Continued SOC therapy together with placebo tablets matching niclosamide

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: From Day 1 to 42