COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001784-88/FI

University of Helsinki - Dept. of Public Health

kari.tikkinen@gmail.com

2020-04-17

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Adult patients, 18 years and above 2. Laboratory-confirmed SARS-2-CoV-2 infection 3. Admitted to the hospital ward or the ICU 4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study 5. No anticipated transfer within 72 hours to a non-study hospital

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.

4

University of Helsinki

18

None

Finland

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

1164

In-hospital mortality in all patients.

Declared number of arm (5.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 121, "treatment_name": "Artesunate", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]