Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

• Status: Suspended
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charité Research Organisation GmbH
• Collaborator: Bayer
• Treatments: Camostat; Niclosamide

Criteria

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)