COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04335786

Roland RJ van Kimmenade, MD PhD

Roland.vanKimmenade@radboudumc.nl

2020-04-06

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria - adult (age ≥ 18 years) - admitted to the hospital of any participating center - confirmed sars-cov-2 infection with either: positive laboratory test for sars-cov-2* ; or positive ct thorax diagnostic for sars-cov-2 infection according to the prevailing criteria - randomization: - within 24 hours of confirmed in-hospital sars-cov-2 infection diagnosis or - within 24 hours of hospital admission in case of pre-hospital confirmed sars-cov-2 infection. - in case there is a lack of laboratory tests for sars-cov-2 in the participating center of the potentially eligible patient, a positive laboratory test for sars-cov-2 will be no longer required. in that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of sars-cov-2 infection of that participating center, such as typical abnormalities on pulmonary ct in the setting of high clinical suspicion of sars-cov-2 infection.

- admitted to icu prior to randomization - currently taking an arb or angiotensin-receptor-neprilysin-inhibitor (arni) - use of other investigational drugs at the time of enrollment - prior reaction or intolerance to an arb or arni; or severe intolerance to an acei, defined as angio-oedema requiring medical intervention - systolic blood pressure < 105mmhg or diastolic blood pressure <65mmhg - potassium greater than 5.5 meq/l within 4 weeks of study enrollment. - estimated glomerular filtration rate (egfr) of < 30ml/min/1.73 m2 within 4 weeks of study initiation - a known history of renal artery stenosis - ast and/or alt > 3 times the upper limit of normal within 4 weeks of study enrollment. in case of mild to moderate liver dysfunction valsartan dosage will be limited to a maximum of 80mg - severe liver dysfunction, biliary cirrhosis or cholestasis - severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of valsartan - concurrent treatment with aliskiren - inability to obtain informed consent - pregnancy or breastfeeding - in females of childbearing age, unwillingness to use birth control or to be sexually abstinent for the duration of the study

2

Radboud University Medical Center

18

None

Netherlands

No restriction on type of patients

0: No restriction on type of patients

23

first occurrence of intensive care unit admission, mechanical ventilation or death

None

Phase 4

[{"arm_notes": "", "treatment_id": 1349, "treatment_name": "Valsartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]