Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (RESERVOIR)

Entero Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Niclosamide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04858425

AZ-NICL-COV-1

Details and patient eligibility

About

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

Exclusion criteria

1. 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.
2. 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.
3. Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Niclosamide

Experimental group

Description:

Niclosamide tablets 400 mg 3 times daily for 14 days

Treatment:

Drug: Niclosamide

Placebo

Placebo Comparator group

Description:

Matching placebo tablets 3 times daily for 14 days

Treatment:

Drug: Placebo