A Pilot study to investigate the cardiac effect and pharmacokinetics of potential combination treatments for COVID-19

Phase 1

• Conditions: Healthy volunteers; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002314-40-AT
• Lead Sponsor: Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-15
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

•Age: between =18 and = 59 years old, has a body weight of at least 50 kg and has a body mass index (BMI) of 18 to 32 kg/m², inclusive
•Ability to comprehend the full nature and purpose of the study, including possible risks.
•Physical examination and laboratory analysis: no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study.
•The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and day 1
•The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end 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 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age:<18 years old
•Unwillingness to sign the informed consent
•The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
•The subject has a history of pancreatitis
•The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV) (Virology results not older than 6 months prior to screening are acceptable)
•The subject has a known or suspected allergy to any of the components of the trial products including ribavirin or lopinavir/ritonavir or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions- - The subject is a smoker (regular use of tobacco or nicotine containing products) within 1 month prior to screening
•The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day 1, or over-the-counter medications within 1 week prior to Day 1, with the exception of paracetamol up to 1 g/day
•The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
•Inability to comprehend the full nature and purpose of the study

Study & Design

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