Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

Study Overview
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Brief Summary
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Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.

Detailed Description
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Niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells. Camostat is approved in Japan for the treatment of chronic pancreatitis and reflux esophagitis. It has been shown to effectively block viral replication in a SARS-CoV-2 animal model. Since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with COVID-19. This study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected COVID-19 patients.

Official Title
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A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 (NICCAM)

Conditions
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Covid19

Intervention / Treatment
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* Drug: Niclosamide + Camostat
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients in the age of 18 to 70 years Having a recent positive direct test for Sars-CoV-2 Having mild or moderate COVID-19 symptoms with no indication for hospitalization due to SARS-CoV-2 infection (WHO Ordinal Scale 1-2) Exclusion Criteria: Severe respiratory symptoms related to COVID-19 requiring oxygen or intensive care (high flow oxygen or mechanical ventilation or ECMO) Patients with preexisting pulmonary diseases requiring oxygen supply Patients with history of hypersensitivity to Camostat or Niclosamide or to any ingredients to any of the two drugs Patients with heart failure (NYHA III or NYHA IV) Patients with proven malignant tumor Patients diagnosed with influenza infection Pregnancy or breastfeeding Immunocompromised patients Creatinine clearance < 60 mL/min aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 2 times upper limit of normal (ULN)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niclosamide + Camostat<br>Patients will receive the combination of niclosamide chewing tablets (2000 mg, once daily) and camostat tablets (600 mg, 4-times daily) over a period of 7 days. | Drug: Niclosamide + Camostat<br>* Niclosamide will be applied in combination with camostat.<br>* Other names: Foipan;|
| Placebo Comparator: Placebo<br>Patients will receive placebo orally over a period of 7 days. | Other: Placebo<br>* Placebo to interventional drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent number of Adverse Events | All pathological and clinically significant findings in physical examinations, vital signs, 12-lead ECGs, oxygen saturation and safety lab including coagulation will be documented as adverse events. Adverse events will be reported on the basis of CTCAE v5.0. | 21 days |