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

Phase 3

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

• Registration Number: CTRI/2020/05/025319
• Lead Sponsor: Sanjay gandhi Post Graduate Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age > 18 years

2. Requirement of hospitalization

3. Randomization within 24 hours of initial presentation to a hospital/diagnosis

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 < 30ml/min/1.73 m2

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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