Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

Covid19 Clinical Trial

— NICCAM  

Official title:

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")

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04750759
• Other study ID #: 201741
• Status: Terminated
• Phase: Phase 2
• Start date: February 3, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: November 2021
• Source: Charité Research Organisation GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Niclosamide + Camostat
Niclosamide will be applied in combination with camostat.

Other:
• Placebo
Placebo to interventional drug

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charité Research Organisation GmbH	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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