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CTRI Number  CTRI/2020/05/025319 [Registered on: 22/05/2020] Trial Registered Prospectively
Last Modified On: 17/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Trial of antihypertensive losartan for additional benefit in treating COVID 19 infection. 
Scientific Title of Study   Angiotensin Receptor Blocker Losartan for prevention of COVID 19 complications: a randomized placebo controlled trial  
Trial Acronym  LICCI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Able Lawrence 
Designation  Professor, Department of Clinical Immunology & Rheumatology 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow 
Address  Department of clinical immunology & rheumatology, C- Blockm 2nd Floor, SGPGIMS, Rae Bareilly Road

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494385  
Fax    
Email  abledoc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Able Lawrence 
Designation  Professor, Department of Clinical Immunology & Rheumatology 
Affiliation   
Address  Department of clinical immunology & rheumatology, C- Blockm 2nd Floor, SGPGIMS, Rae Bareilly Road


UTTAR PRADESH
226014
India 
Phone  05222494385  
Fax    
Email  abledoc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Able Lawrence 
Designation  Professor, Department of Clinical Immunology & Rheumatology 
Affiliation   
Address  Department of clinical immunology & rheumatology, C- Blockm 2nd Floor, SGPGIMS, Rae Bareilly Road


UTTAR PRADESH
226014
India 
Phone  05222494385  
Fax    
Email  abledoc@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Sanjay gandhi Post Graduate Institute of Medical Sciences 
Address  Rae bareilly road, Lucknow. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Able Lawrence  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Rae bareilly road, Lucknow
Lucknow
UTTAR PRADESH 
05222494385

abledoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, SGPGI Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Losartan  Losartan 25mg given twice a day till discharge or outcome.  
Comparator Agent  Placebo  Given twice a day in same schedule as intervention till discharge or outcome 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age> 18 years
2. Requirement of hospitalization
3. Randomization within 24 hours of initial presentation to a hospital/diagnosis 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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 
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 Outcome  
Outcome  TimePoints 
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 Stay  
28 days.
Continuous assessment for respiratory failure requiring ventilator, change in SOFA score, need for ICU admission. 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   COVID 19 is a global pandemic disease caused by the novel coronavirus named SARS-CoV2. Currently, there is no approved treatment for COVID 19. The virus utilized ACE2 on the surface of cells to enter into the cell and in the process causes internalization and destruction of ACE2. The two major complications of COVID19, namely ARDS and fulminant myocardial failure best explained by excessive Angiotensin II activation through AT1R due to loss of ACE2 and can be potentially reversed by ARBs. A network analysis of existing drugs to identify candidates for repurposing against COVID19 based on gene expression changes induced by the virus and the candidate drugs identified Irbesartan, an angiotensin receptor blocker.  Hence, we propose to undertake a randomized control trial of Losartan, an angiotensin receptor blocker with an excellent safety record of 25 years as adjunctive therapy to the standard of care given to patients of COVID 19. Losartan being a safe and easily available drug if found to be effective in management will be a welcome addition in the armamentarium of drugs to treat COVID-19 especially in a resource-constrained country like India 
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