Status:
TERMINATED
Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
Lead Sponsor:
Charité Research Organisation GmbH
Collaborating Sponsors:
Bayer
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04750759
Start Date
February 3 2021
End Date
October 29 2021
Last Update
December 9 2021
Active Locations (1)
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1
Charité Research Organisation GmbH
Berlin, Germany, 10117