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

Phase 4

Completed

• Conditions: COVID-19; corona virus infectious disease; 10047438; 10024970

• Registration Number: NL-OMON49095
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 651

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.

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 < 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the occurrence within 14 days of randomization of<br /><br>either: 1) ICU admission; 2) Mechanical ventilation; 3) Death. The occurrence<br /><br>of the main study endpoint will be assessed on a daily basis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Death within 14 days, 30 days, 90 days and at 1 year, defined as all-cause<br /><br>mortality.<br /><br>* Mechanical ventilation and ICU admission within 14 days.<br /><br>* Time to ICU admission, mechanical ventilation and death.<br /><br>* Occurrence of acute kidney injury within 14 days defined as a 50% decline in<br /><br>estimated glomerular filtration rate relative to baseline, or decrease of >30<br /><br>ml/min/1.73m2 and to a value below 60 ml/min/1.73m2.</p><br>