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

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

Official Title
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A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

Conditions
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Covid19

Intervention / Treatment
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* Drug: Niclosamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niclosamide<br>Niclosamide tablets 400 mg 3 times daily for 14 days | Drug: Niclosamide<br>* Niclosamide tablets 400 mg 3 times daily for 14 days<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets 3 times daily for 14 days | Drug: Placebo<br>* Matched placebo tablets 400 mg 3 times daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs | Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA). | Day 1 to 6 weeks | 
| TEAE | Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation. | Day 1 to 6 weeks | 
| Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes | Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided. | Day 1 to Day 43 | 
| Fecal RNA virus Clearance | Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm. | Day 1 to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Severity Score | Proportion of patients with each clinical severity score as recommended by the World Health Organization (WHO) for COVID-19 studies by study visit; | Day 1 to 6 weeks | 
| Time to Resolution of Diarrhea | Time from the first dose of study treatment to the last loose or watery stool in patients with loose or watery stool (Bristol Stool Scale Types 5-7). | Day 1 to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Covid, Covid19 Diarrhea, Covid19 GI Infection