COVID-19 Hydroxychloroquine for COVID-19

Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction in throat swabs

• In-hospital mortality within 60 days
• All-cause mortality within 60 days
• Proportion requiring non-invasive ventilation
• Proportion requiring invasive ventilation
• Proportion admitted to ICU
• Duration of hospitalization
• Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve
• Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level

Exploratory objectives: effect of infection on cardiac function, mucosal, humoral and cellular immune response including single cell phenotype and RNA expression, effect on anti-viral defense, assessment of chronic symptoms and quality of life

• 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 hospitalization
• QTc interval lower than 450 msec

• 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