EUCTR2020-001224-33-DE
Active, not recruiting
Phase 1
Randomized controlled trial of hydroxychloroquine versus placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19
niversitätsklinikum Tübingen0 sites220 target enrollmentMarch 24, 2020
ConditionsAcute coronavirus disease 2019MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsQuensyl
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute coronavirus disease 2019
- Sponsor
- niversitätsklinikum Tübingen
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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