Created at Source Raw Value Validated value
Nov. 6, 2020, 11:45 p.m. oms

From the Master Study 1. Abnormal physical examination findings: • respiratory rate over or equal to 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients over or equal to 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis, • recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L). 2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. 3. Feeling unwell for more than 7 days prior to screening. 4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency. 5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm. 6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision. 7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. 8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. 9. Pregnancy based on urine pregnancy test at screening or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis. 10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir. 11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.

From the Master Study 1. Abnormal physical examination findings: • respiratory rate over or equal to 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients over or equal to 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis, • recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L). 2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. 3. Feeling unwell for more than 7 days prior to screening. 4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency. 5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm. 6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision. 7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. 8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. 9. Pregnancy based on urine pregnancy test at screening or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis. 10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir. 11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.