SARS-CoV-2 infection
Conditions
Interventions
Product Name: Valsartan or matched placebo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALSARTAN
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis OR 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. 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
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.;Secondary Objective: • Death within 14 days, 30 days, 90 days and at 1 year, defined as all-cause mortality. • Mechanical ventilation and ICU admission within 14 days. • Time to ICU admission, mechanical ventilation and death. • Occurrence of acute kidney injury within 14 days defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2. ;Primary end point(s): The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death. ;Timepoint(s) of evaluation of this end point: The occurrence of the main study endpoint will be assessed on a daily basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - All secondary endpoints will be evaluated after the study treatment has ended. - death within 30 days, 90 days and 1 year will be evaluated at those timepoints. ;Timepoint(s) of evaluation of this end point: For the secondary outcome measures regarding mortality at 30 days, 90 days and 1 year we will use the national database of Central Bureau of Statistics for follow-up. For the other secondary outcome measures the follow-up duration will be until the occurrence of the primary endpoint or 14 days after randomization. | — |
Countries
Netherlands
Contacts
Public ContactCardiology Research Department
Radboudumc
Outcome results
None listed