Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (NICCAM)

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")

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Niclosamide + Camostat; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Niclosamide + Camostat; Niclosamide will be applied in combination with camostat.; Other Names: Yomesan; Foipan
Placebo Comparator: Placebo; Patients will receive placebo orally over a period of 7 days.	Other: Placebo; Placebo to interventional drug

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charité Research Organisation GmbH
• Collaborators: Bayer
• Investigators: Principal Investigator: Martin Witzenrath, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Antiparasitic Agents; Trypsin Inhibitors; Antinematodal Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Niclosamide; Camostat
• Other Study ID Numbers: 201741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No