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NICCAM: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

Sponsor
Charité Research Organisation GmbH (Other)
Overall Status
Terminated
CT.gov ID
NCT04750759
Collaborator
Bayer (Industry)
4
Enrollment
1
Location
2
Arms
8.8
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Niclosamide + Camostat
  • Other: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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")
Actual Study Start Date :
Feb 3, 2021
Actual Primary Completion Date :
Oct 29, 2021
Actual Study Completion Date :
Oct 29, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Niclosamide + Camostat
Niclosamide will be applied in combination with camostat.
Other Names:
  • Yomesan
  • Foipan

    		•
    Placebo Comparator: Placebo

    Patients will receive placebo orally over a period of 7 days.

    Other: Placebo
    Placebo to interventional drug

    Outcome Measures

    Primary Outcome Measures

    1. Treatment emergent number of Adverse Events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité Research Organisation GmbH Berlin Germany 10117

    Sponsors and Collaborators

    • Charité Research Organisation GmbH
    • Bayer

    Investigators

    • Principal Investigator: Martin Witzenrath, Prof., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charité Research Organisation GmbH
    ClinicalTrials.gov Identifier:
    NCT04750759
    Other Study ID Numbers:
    • 201741
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Niclosamide
    Camostat

    Study Results

    No Results Posted as of Dec 9, 2021