COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8491

Harm Jan Bogaard

hj.bogaard@amsterdamumc.nl

2020-03-31

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

- Age >18 years- Hospital admission with proven SARS2-Covid19 infection- Hypoxemic respiratory failure (SaO2 <92%, PaO2 <8kPa)- Ability to give informed consent

1. Pre-existing chronic pulmonary disease, including:? Known diagnosis of Interstitial Lung disease? Former diagnosis of COPD 4 or FEV1<30%pred? DLCO <45%? Total lung capacity (TLC) < 60% of predicted? Lung cancer with non-surgical treatment in last year2. Home oxygen treatment3. Pre-existing heart failure with a known left ventricular ejection fraction <40%4. Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy in the last year4. Inability to provide informed consent5. 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 study6. Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN7. History or suspicion of inability to cooperate adequately.8. White blood count < 4.0^109/l9. Hemoglobin < 6.0 mmol/l10. Thrombocytes < 100^109/l11. Pregnant female subjects12. Breastfeeding female subjects

2

Amsterdam UMC

18

None

Netherlands

Severe disease at enrollment

6: Severe disease at enrollment

386

time to liberation from ventilation and supplemental oxygen and alive during a 28day period after randomization

Not reported

[{"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"}]