COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001236-10/BE

Amsterdam UMC - Jurjan Aman

j.aman@amsterdamumc.nl

2020-11-16

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

- Age >18 years - Hospital admission with proven SARS2-Covid19 infection - Hypoxemic respiratory failure (SaO2 <94%, PaO2 <9kPa) - Ability to give informed consent.

- Pre-existing chronic pulmonary disease - Former diagnosis of Interstitial pulmonary disease - Former diagnosis of COPD 4 or FEV1<30%pred - Previous DLCO <45% - Total lung capacity (TLC) < 60% of predicted - Lung cancer with non-surgical treatment in last year - Chronic home oxygen treatment - Pre-existing heart failure with a known left ventricular ejection fraction <40% - Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy or targeted radiotherpay in the last year - Inability to provide informed consent - Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study - Active liver disease, porphyria or elevations of serums transaminases >5 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN - History or suspicion of inability to cooperate adequately. - White blood count < 4.0^109/l - Hemoglobin < 6.0 mmol/l - Thrombocytes < 100^109/l - Pregnant female subjects - Breastfeeding female subjects - Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine - Concomittant use of chloroquine or hydroxychloroquine. - QTc >500msec at baseline.

2

Amsterdam UMC

18

100

Netherlands

Severe disease at enrollment

6: Severe disease at enrollment

50

Time to liberation from ventilation and supplemental oxygen >48h while being alive during a 28-day period after randomization

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]