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.
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.
Drug: Niclosamide + Camostat
Niclosamide will be applied in combination with camostat.
Other Name: Array
Other: Placebo
Placebo to interventional drug
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)
Charité Research Organisation GmbH
Berlin, Germany
Martin Witzenrath, Prof., Principal Investigator
Charite University, Berlin, Germany