Status:
TERMINATED
Valsartan for Prevention of Acute Respiratory Distress Syndrome in Hospitalized Patients With SARS-COV-2 (COVID-19) Infection Disease
Lead Sponsor:
Radboud University Medical Center
Conditions:
Acute Respiratory Distress Syndrome
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RA...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04335786
Start Date
April 17 2020
End Date
May 25 2021
Last Update
September 24 2021
Active Locations (7)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Rijnstate
Arnhem, Netherlands, 6815AD
3
Radboudumc
Nijmegen, Netherlands
4
Laurentius Ziekenhuis
Roermond, Netherlands