Created at Source Raw Value Validated value
April 23, 2021, 1:30 a.m. eu

GENERAL: 1.Severe co-morbidity with life expectancy <3 months according to investigators assessment 2.ASAT/ALAT > 5 times the upper limit of normal 3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction or UAP (not including troponin elevation due to infection) 4.Pregnancy or breast feeding 5.Any reason why, in the opinion of the investigators, the patient should not participate 6.Subject participates in a potentially confounding drug or device trial during the course of the study 7.Already receiving any of the study drugs 8.Renal failure (eGRF < 30 mL/min) or dialysis or continuous veno-venous hemofiltration DRUG-SPECIFIC: 1.Suspected (or confirmed) active / latent tuberculosis i. Cannot be randomized to the study arm: infliximab 2.Suspected (or confirmed) hepatitis B carrier i. Cannot be randomized to the study arm: infliximab and imatinib 3.Severe bacterial infection i. Cannot be randomized to the study arm: infliximab 4.Heart failure (NYHA class 3-4) i. Cannot be randomized to the study arm: infliximab 5.Hepatic impairment (cirrhosis) i. Cannot be randomized to the study arm: imatinib 6.Demyelinating disease (such as multiple sclerosis) i. Cannot be randomized to the study arm: infliximab 7.If the patient is hypersensitive to artesunate, infliximab or imatinib (or immunized with infliximab), the patient will not be included in the randomization for the arm for which he is hypersensitive (or immunized). For example, if a patient is hypersensitive to artesunate, he or she will be included in a randomization with alternatives to i) standard care, ii) standard care + infliximab, and iii) standard care + imatinib.

GENERAL: 1.Severe co-morbidity with life expectancy <3 months according to investigators assessment 2.ASAT/ALAT > 5 times the upper limit of normal 3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction or UAP (not including troponin elevation due to infection) 4.Pregnancy or breast feeding 5.Any reason why, in the opinion of the investigators, the patient should not participate 6.Subject participates in a potentially confounding drug or device trial during the course of the study 7.Already receiving any of the study drugs 8.Renal failure (eGRF < 30 mL/min) or dialysis or continuous veno-venous hemofiltration DRUG-SPECIFIC: 1.Suspected (or confirmed) active / latent tuberculosis i. Cannot be randomized to the study arm: infliximab 2.Suspected (or confirmed) hepatitis B carrier i. Cannot be randomized to the study arm: infliximab and imatinib 3.Severe bacterial infection i. Cannot be randomized to the study arm: infliximab 4.Heart failure (NYHA class 3-4) i. Cannot be randomized to the study arm: infliximab 5.Hepatic impairment (cirrhosis) i. Cannot be randomized to the study arm: imatinib 6.Demyelinating disease (such as multiple sclerosis) i. Cannot be randomized to the study arm: infliximab 7.If the patient is hypersensitive to artesunate, infliximab or imatinib (or immunized with infliximab), the patient will not be included in the randomization for the arm for which he is hypersensitive (or immunized). For example, if a patient is hypersensitive to artesunate, he or she will be included in a randomization with alternatives to i) standard care, ii) standard care + infliximab, and iii) standard care + imatinib.

Oct. 26, 2020, 7:26 a.m. eu

1.Severe co-morbidity with life expectancy <3 months according to investigators assessment 2.ASAT/ALAT > 5 times the upper limit of normal 3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction or UAP (not including troponin elevation due to infection) 4.Known intolerance to the available study drugs 5.Pregnancy or breast feeding 6.Any reason why, in the opinion of the investigators, the patient should not participate 7.Subject participates in a potentially confounding drug or device trial during the course of the study 8.Already receiving any of the study drugs 9.Renal failure (eGRF < 30 mL/min) or dialysis or continuous veno-venous hemofiltration

1.Severe co-morbidity with life expectancy <3 months according to investigators assessment 2.ASAT/ALAT > 5 times the upper limit of normal 3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction or UAP (not including troponin elevation due to infection) 4.Known intolerance to the available study drugs 5.Pregnancy or breast feeding 6.Any reason why, in the opinion of the investigators, the patient should not participate 7.Subject participates in a potentially confounding drug or device trial during the course of the study 8.Already receiving any of the study drugs 9.Renal failure (eGRF < 30 mL/min) or dialysis or continuous veno-venous hemofiltration