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Using the blood pressure medication losartan to improve outcomes for patients with SARS CoV-2

RAAS blockagE in SARS COV-2 Critically ill patiEnts– a Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48734830
Enrollment
750
Registered
2020-07-10
Start date
2020-08-03
Completion date
Unknown
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

Patients in the active arm of the trial will be receiving open-label Losartan in a dosage titrated with regards to blood pressure and renal function up to a maximum of 100 mg once daily. Active treatm

Sponsors

Stockholm South General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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)

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of a composite endpoint (admission to intensive care unit, or death), within 28 days of randomization

Secondary

MeasureTime frame
Measured using case report form: 1. All-cause mortality at day 28 from randomization 2. Occurrence of ICU admission during hospital stay 3. Need for and duration of invasive mechanical ventilation 4. Peak level and area under the curve during hospitalization for National Early Warning score 2 (NEWS2) score 5. Peak level and area under the curve during hospitalization for CRP score

Countries

Sweden

Contacts

Public ContactGustaf Edgren
gustaf.edgren@ki.se+46 86164782

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026