A study to investigate the safety and efficacy of two approved drugs, niclosamide and camostat, administered in combination and compared to placebo in COVID-19 patients

Phase 1

Active, not recruiting

• Conditions: SARS-Coronavirus 2 disease 2019 (COVID-19); MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002233-15-DE
• Lead Sponsor: Charité Research Organisation GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 40

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

? 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified