Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

NCT04750759 | Terminated Phase 2 DMC

• 1 other identifier: 201741
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  21 days

Study Arms (2)

Niclosamide + Camostat

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Niclosamide + Camostat DRUG

Niclosamide will be applied in combination with camostat.

Also known as: Yomesan, Foipan

Niclosamide + Camostat

Placebo OTHER

Placebo to interventional drug

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charité Research Organisation GmbH: lead
• Bayer: collaborator

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

Niclosamide; camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Study Officials

• Martin Witzenrath, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: February 3, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)