MedDataX Logo

Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

NCT ID: NCT04750759

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2021-10-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Niclosamide + Camostat

Intervention Type DRUG

Niclosamide will be applied in combination with camostat.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to interventional drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Niclosamide + Camostat

Niclosamide will be applied in combination with camostat.

Intervention Type DRUG

Placebo

Placebo to interventional drug

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Yomesan Foipan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role collaborator

Charité Research Organisation GmbH

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Witzenrath, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité Research Organisation GmbH

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201741

Identifier Type: -

Identifier Source: org_study_id