Status:
TERMINATED
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Lead Sponsor:
Entero Therapeutics
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
Eligibility Criteria
Inclusion
- Part 1 only, patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures.
- Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.
Exclusion
- At the time of randomization, patients who require intensive care unit (ICU) admission or patients with severe respiratory insufficiency who require 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 that, in the opinion of the investigator, makes the patient unsuitable for inclusion.
- Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2023
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04858425
Start Date
April 30 2021
End Date
September 10 2023
Last Update
October 8 2024
Active Locations (25)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720-0920
3
New Generation Medical Research
Hialeah, Florida, United States, 33016-1895
4
LCC Medical Reserach Institute, LLC
Miami, Florida, United States, 33126