Systematic study of the medicine hydroxychloroquine against placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19

Phase 1

• Conditions: Acute coronavirus disease 2019; MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001224-33-DE
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

•Written informed consent
•Age above 18 years
•Women of childbearing age only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year)
•Disease severe enough to require hospitalisation
•QTc interval lower than 450 msec

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 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Respiratory rate >24/min
•Pregnancy or lactation
•Weight <50 kg
•Hemodynamic/rhythm instability
•Acute myocardial infarction Type 1
•Use of concomitant medications that prolong the QT/QTc interval.
•Any regular concomitant medication which is contraindicated in the use together with HCQ
•Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines
•Pre-existing retinopathy or maculopathy
•Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
•Haematopoietic systems diseases
•Myasthenia gravis
•Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

Study & Design

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