SARS-Coronavirus 2 disease 2019 (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Yomesan®
Product Name: Niclosamide
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Niclosamide
CAS Number: 50-65-7
Other descriptive name: NICLOSAMIDE
Concentration unit: mg mill
Sponsors
Charité Research Organisation GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male and female patients ? Age >18-70 years at the time of informed consent signature ? having a recent positive direct test for Sars-CoV-2 ? having mild or moderate Covid-19 symptoms (not needing more than 4 l oxygen per minute to reach a saturation of 95%) ? Body Mass Index (BMI) between 18.0 and 30 kg/m², inclusive at screening. ? Subject must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in it (including willing to be hospitalized during the medication period of the study). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: ? Severe respiratory symptoms related to Covid-19 requiring intensive care (high flow oxygen or invasive measurements) ? Patients with pulmonary diseases requiring oxygen supply in medical history ? 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 ? Currently proven influenza infection ?Pregnancy or breastfeeding ?History of human immunodeficiency virus 1 or 2 (HIV-1, HIV-2) antibody positive, or tests positive for HIV at screening; acute and chronic infection with hepatitis B or hepatitis C or serologic evidence for active viral hepatitis ?Immunocompromised patients ?Creatinine clearance 2xULN ?Serum potassium > 5.5 mmol/L, platelets < 100.000/ml at Screening ?Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations. ?Inability or unwillingness to comply with study procedures, including study prohibitions and restrictions. ?Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. ?Staff member or relative of a staff member, or a subordinate relationship with the Investigator. ?Vulnerable subject who lives in an institution on court or authority order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of the treatment combination Niclosamide and Camostat in mild to moderately affected COVID-19 patients.;Secondary Objective: ?To assess the preliminary efficacy (“proof of concept”) of Camostat and Niclosamide in combination in mild to moderately affected COVID-19 patients. ?To assess the effect of Camostat and Niclosamide in combination on viral load in mild to moderately affected COVID-19 patients ?To assess the effect of Camostat and Niclosamide in combination on biomarkers in mild to moderately affected COVID-19 patients.;Primary end point(s): The primary endpoint of the study is safety which will be evaluated according to the following parameters: ? Adverse event monitoring - AEs and SAEs ? Physical examination ? Vital sign monitoring (blood pressure, pulse rate, temperature, respiratory rate) ? Oxygen saturation ? Safety lab including coagulation;Timepoint(s) of evaluation of this end point: at time of IMP administration until follow-up visit 2 (day 14 after end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Preliminary efficacy: The following efficacy endpoints will be evaluated for preliminary proof of concept: - Time weighted viral load (SARS-CoV-2) in swabs - WHO Clinical Improvement ordinal scale (0 – 8) - Time to clinical improvement, defined as the time from randomization to either an improvement of two points on an eight-category ordinal scale or discharge from the hospital, whichever came first - SpO2/FiO2 - SpO2 - Breathing rate - Number of patients in the ICU on mechanical ventilation - Body temperature Biomarker evaluation: ? hs-CRP ? IL-6 ? Ferritin ? LDH ? various immunological biomarkers;Timepoint(s) of evaluation of this end point: at time of IMP administration until follow-up visit 2 (day 14 after end of treatment) | — |
Countries
Germany
Contacts
Public ContactKristin Herzog
Charité Research Organisation GmbH
Outcome results
None listed