Created at Source Raw Value Validated value
Oct. 7, 2021, 9:30 a.m. oms

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 3. Feeling unwell for more than 7 days prior to screening. 4 to 7 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 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.-13 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 14. On-going treatment at screening with: • chronic systemic glucocorticosteroid > 40 mg daily, • immunosuppressive treatment, 15. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. 16. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber. 17. Any other reason that makes it impossible to monitor the patient during the study. 18. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening. 19. Known pulmonary arterial hypertension (PAH) or fibrosis. 20. Use of concomitant medications that are contraindicated with ciclesonide, known hypersensitivity to ciclesonide or any other ingredient in the formulation. 21........

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 3. Feeling unwell for more than 7 days prior to screening. 4 to 7 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 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.-13 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 14. On-going treatment at screening with: • chronic systemic glucocorticosteroid > 40 mg daily, • immunosuppressive treatment, 15. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. 16. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber. 17. Any other reason that makes it impossible to monitor the patient during the study. 18. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening. 19. Known pulmonary arterial hypertension (PAH) or fibrosis. 20. Use of concomitant medications that are contraindicated with ciclesonide, known hypersensitivity to ciclesonide or any other ingredient in the formulation. 21........

Nov. 6, 2020, 11:45 p.m. oms

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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. Known pregnancy 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. 12. Use of concomitant medications that are contraindicated

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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. Known pregnancy 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. 12. Use of concomitant medications that are contraindicated

Oct. 26, 2020, 8:29 a.m. oms

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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) or hyperkalaemia (> 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. Known pregnancy 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. 12. Use of concomitant medications that are contraindicated

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > or= 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) or hyperkalaemia (> 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. Known pregnancy 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. 12. Use of concomitant medications that are contraindicated