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

Charité Research Organisation GmbH

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Other: Placebo; Drug: Niclosamide + Camostat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04750759

201741

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups, including a placebo group

Niclosamide + Camostat

Active Comparator group

Description:

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.

Treatment:

Drug: Niclosamide + Camostat

Placebo

Placebo Comparator group

Description:

Patients will receive placebo orally over a period of 7 days.

Treatment:

Other: Placebo