Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Niclosamide + Camostat; Other: Placebo

• Registration Number: NCT04750759
• Lead Sponsor: Charité Research Organisation GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Primary Completion: 2021-10-29
• Study Completion: 2021-10-29
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niclosamide + Camostat	Niclosamide + Camostat	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.
Placebo	Placebo	Patients will receive placebo orally over a period of 7 days.

Primary Outcome Measures

Name	Time	Method
Treatment emergent number of Adverse Events	21 days	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.

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany