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

F

First Wave BioPharma

Status and phase

Active, not recruiting
Phase 2

Conditions

Covid19

Treatments

Drug: Placebo
Drug: Niclosamide

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

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

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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