COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42751

Dr Able Lawrence

abledoc@gmail.com

2020-05-22

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

1. Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB) <br/ >2. Prior reaction or intolerance to an ARB or ACEi <br/ >3. Blood pressure less than 100/70 mmHg <br/ >4. Potassium great than 5.0 mEq/L <br/ >5. Pregnancy or breastfeeding In females of childbearing age, unwillingness to use birth control for the duration of the study <br/ >6. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 <br/ >7. AST and/or ALT > 3 times the upper limit of normal <br/ >8. Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of Losartan <br/ >9. Concurrent treatment <br/ >10. Inability to obtain informed consent <br/ >11. Pregnancy

2

Sanjay gandhi Post Graduate Institute of Medical Sciences

18

99

India

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

186

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

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 744, "treatment_name": "Losartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]