Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radboud University Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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