sing the blood pressure medication losartan to improve outcomes for patients with SARS CoV-2
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN48734830
- Lead Sponsor
- Stockholm South General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 302
1. Positive PCR laboratory test for SARS-CoV-2
2. Age > 18 years
3. Admitted for in-hospital care no more than 48 hours earlier
4. GCS = 14
1. Admitted to ICU prior to randomization.
2. Current treatment with blood pressure lowering agent, affecting the RAAS system (i.e. Angiotensin Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), Aldosteron antagonist or Renin inhibitor)
3. Patients with heart condition eg. heart failure with reduced ejection fraction, EF < 40%, who has an evidence based indication for ACE inhibitors or Angiotensin receptor blockers
4. Prior serious adverse reaction to an ARB or ACEi
5. Systolic blood pressure below 120 mmHg or symptomatic hypotension. Blood pressure will be taken in supine position after 5 minutes rest with manual or automatic blood pressure manometers
6. Estimated Glomerular Filtration Rate (eGFR) of < 50ml/min/1.73 m²
7. Potassium > 5 mEq/l
8. Women of childbearing age. Pregnant or breastfeeding. Women that are postmenopausal can be included. Women and childbearing age can be included after a negative pregnancy test
9. Known renal artery stenosis
10. Severe hepatic failure (i.e. ALAT/ASAT > 5x normal upper limit)
11. Volume depletion, chock or new onset of acute kidney injury that, in the opinion of the investigator, would preclude administration of ARB/ACE-inhibitors
12. Any condition or therapy which would make the participant unsuitable for the study, according to the investigators opinion
13. Inability to provide informed consent
14. Moribund or palliative patients deemed unlike to survive hospital stay or who cannot make an informed decision for participations (e.g. non-adults or patients with dementia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first occurrence of a composite endpoint (admission to intensive care unit, or death), within 28 days of randomization
- Secondary Outcome Measures
Name Time Method Measured using case report form:<br>1. All-cause mortality at day 28 from randomization<br>2. Occurrence of ICU admission during hospital stay<br>3. Need for and duration of invasive mechanical ventilation<br>4. Peak level and area under the curve during hospitalization for National Early Warning score 2 (NEWS2) score<br>5. Peak level and area under the curve during hospitalization for CRP score