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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Niclosamide + Camostat
Placebo
Sponsored by
Charité Research Organisation GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Charité Research Organisation GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Niclosamide + Camostat

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2021
Last Updated
November 26, 2021
Sponsor
Charité Research Organisation GmbH
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04750759
Brief Title
Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
Acronym
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")
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
sub-therapeutic plasma levels of active substance
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charité Research Organisation GmbH
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niclosamide + Camostat
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo orally over a period of 7 days.
Intervention Type
Drug
Intervention Name(s)
Niclosamide + Camostat
Other Intervention Name(s)
Yomesan, Foipan
Intervention Description
Niclosamide will be applied in combination with camostat.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to interventional drug
Primary Outcome Measure Information:
Title
Treatment emergent number of Adverse Events
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Witzenrath, Prof.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Research Organisation GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

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