A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease - PRAETORIAN-COVID

Radboudumc0 个研究点目标入组 651 人开始时间: 2020年3月30日最近更新: 2021年6月28日

试验速览

暂无简介。

•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:
•oWithin 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis
•owithin 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 260
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 391

•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
•Blood pressure less than 105/65 mmHg
•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, bile 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

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