COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002233-15/DE

Charité Research Organisation GmbH - Kristin Herzog

kristin.herzog@charite-research.org

2020-05-13

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

 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).

 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 < 60 mL/min AST/ALT > 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.

3

Charité Research Organisation GmbH

18

70

Germany

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

40

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

nan

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1438, "treatment_name": "Camostat mesilate+niclosamide", "treatment_type": "Antivirals+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}]