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

Radboud Universitair Medisch Centrum0 个研究点目标入组 651 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•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:
•o Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis
•o 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
•* 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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