Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

1. ALT/AST > 8 times the upper limit of normal. 2. Pregnancy or breastfeeding. 3. Allergy to any study medication. 4. Any medical condition which would impose an unacceptable safety hazard by participation in the study. 5. Study drug-specific exclusion criteria: For Aprotinin: o Known active thromboembolic disease, defined as a history of idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism, recent (<3m) deep vein thrombosis or pulmonary embolism, recent (<6m) myocardial infarction or coronary stenting, recent (<6m) ischemic stroke o Renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis o Recent (<6m) cardiac surgery with cardiopulmonary bypass and/or use of aprotinin For LMWH: o Active bleeding, a history of intracranial bleeding, or a recent (<3m) GI bleeding requiring transfusion and/or intervention, recent surgery in the central nervous system o Renal insufficiency with CrCl < 20ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis o Blood platelet count < 30 000/µL o Other conditions that are judged to carry an increased risk of bleeding as judged by the investigator o Need for therapeutic anticoagulation (known active thrombo-embolic diseases, atrial fibrillation, mechanical prosthetic heart valve,…) For Anakinra: o Impairment of cardiac function defined as severe heart failure, unstable angina pectoris, myocardial infarction within 6 months before enrollment, ventricular arrhythmia requiring treatment or intervention. o Severe renal dysfunction (creatinine clearance ≤ 20mL/min) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. o Uncontrolled hypertension (persistent systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg) o Clinical suspicion of latent tuberculosis o Clinical suspicion of severe bacterial surinfection (e.g. ventilator-associated pneumonia)

1. ALT/AST > 8 times the upper limit of normal. 2. Pregnancy or breastfeeding. 3. Allergy to any study medication. 4. Any medical condition which would impose an unacceptable safety hazard by participation in the study. 5. Study drug-specific exclusion criteria: For Aprotinin: o Known active thromboembolic disease, defined as a history of idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism, recent (<3m) deep vein thrombosis or pulmonary embolism, recent (<6m) myocardial infarction or coronary stenting, recent (<6m) ischemic stroke o Renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis o Recent (<6m) cardiac surgery with cardiopulmonary bypass and/or use of aprotinin For LMWH: o Active bleeding, a history of intracranial bleeding, or a recent (<3m) GI bleeding requiring transfusion and/or intervention, recent surgery in the central nervous system o Renal insufficiency with CrCl < 20ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis o Blood platelet count < 30 000/µL o Other conditions that are judged to carry an increased risk of bleeding as judged by the investigator o Need for therapeutic anticoagulation (known active thrombo-embolic diseases, atrial fibrillation, mechanical prosthetic heart valve,…) For Anakinra: o Impairment of cardiac function defined as severe heart failure, unstable angina pectoris, myocardial infarction within 6 months before enrollment, ventricular arrhythmia requiring treatment or intervention. o Severe renal dysfunction (creatinine clearance ≤ 20mL/min) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. o Uncontrolled hypertension (persistent systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg) o Clinical suspicion of latent tuberculosis o Clinical suspicion of severe bacterial surinfection (e.g. ventilator-associated pneumonia)