A clinicial trial to investigate te effect of valsartan compared to placebo on acute respiratory failure in hospitalized SARS-CoV-2-infected patients

Phase 1

• Conditions: SARS-CoV-2 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001320-34-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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:
oWithin 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis
OR
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

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 clinical trial of medicinal product
• Study Design: Not specified