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Trial of antihypertensive losartan for additional benefit in treating COVID 19 infection.

Angiotensin Receptor Blocker Losartan for prevention of COVID 19 complications: a randomized placebo controlled trial - LICCI

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025319
Enrollment
186
Registered
2020-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Losartan: Losartan 25mg given twice a day till discharge or outcome. Control Intervention1: Placebo: Given twice a day in same schedule as intervention till discharge or outcome

Sponsors

Sanjay gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Requirement of hospitalization 3. Randomization within 24 hours of initial presentation to a hospital/diagnosis

Exclusion criteria

Exclusion criteria: 1. Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB) 2. Prior reaction or intolerance to an ARB or ACEi 3. Blood pressure less than 100/70 mmHg 4. Potassium great than 5.0 mEq/L 5. Pregnancy or breastfeeding In females of childbearing age, unwillingness to use birth control for the duration of the study 6. Estimated Glomerular Filtration Rate (eGFR) of 7. AST and/or ALT > 3 times the upper limit of normal 8. Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of Losartan 9. Concurrent treatment 10. Inability to obtain informed consent 11. Pregnancy

Design outcomes

Primary

MeasureTime frame
Percentage of patient with treatment failure: Treatment failure defined as any of following after 48 hours of randomization i) A Fall in 1 score in Respiratory SOFA score ii) New requirement of respiratory assist devices (HFNC, NIV) iii) New requirement of mechanical ventilation iv) MortalityTimepoint: Percentage of patient with treatment failure: Treatment failure defined as any of following after 48 hours of randomization i) A Fall in 1 score in Respiratory SOFA score ii) New requirement of respiratory assist devices (HFNC, NIV) iii) New requirement of mechanical ventilation iv) Mortality

Secondary

MeasureTime frame
1. 28-Day Mortality 2. Change in SOFA score 3. Worsening of ARDS categories 4. Respiratory Failure requiring Mechanical Ventilation 5. Length of Hospital Stay 6. ICU Admission 7. ICU Length of StayTimepoint: 28 days. Continuous assessment for respiratory failure requiring ventilator, change in SOFA score, need for ICU admission.

Countries

India

Contacts

Public ContactDr Able Lawrence
abledoc@gmail.com05222494385

Outcome results

None listed

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