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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04750759
Recruitment Status : Terminated (sub-therapeutic plasma levels of active substance)
First Posted : February 11, 2021
Last Update Posted : December 9, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Charité Research Organisation GmbH

Tracking Information
First Submitted Date  ICMJE February 8, 2021
First Posted Date  ICMJE February 11, 2021
Last Update Posted Date December 9, 2021
Actual Study Start Date  ICMJE February 3, 2021
Actual Primary Completion Date October 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
Treatment emergent number of Adverse Events [ Time Frame: 21 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
Official Title  ICMJE 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")
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Niclosamide + Camostat
    Niclosamide will be applied in combination with camostat.
    Other Names:
    • Yomesan
    • Foipan
  • Other: Placebo
    Placebo to interventional drug
Study Arms  ICMJE
  • Active Comparator: Niclosamide + Camostat
    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.
    Intervention: Drug: Niclosamide + Camostat
  • Placebo Comparator: Placebo
    Patients will receive placebo orally over a period of 7 days.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 26, 2021)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
40
Actual Study Completion Date  ICMJE October 29, 2021
Actual Primary Completion Date October 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04750759
Other Study ID Numbers  ICMJE 201741
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Charité Research Organisation GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Charité Research Organisation GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Martin Witzenrath, Prof. Charite University, Berlin, Germany
PRS Account Charité Research Organisation GmbH
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP