Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Suspended (pandemic sitation)
First Posted : February 11, 2021
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Charité Research Organisation GmbH

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
Covid19 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : February 3, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750759


Locations
Layout table for location information
Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
Sponsors and Collaborators
Charité Research Organisation GmbH
Bayer
Investigators
Layout table for investigator information
Principal Investigator: Martin Witzenrath, Prof. Charite University, Berlin, Germany
Layout table for additonal information
Responsible Party: Charité Research Organisation GmbH
ClinicalTrials.gov Identifier: NCT04750759    
Other Study ID Numbers: 201741
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niclosamide
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents