| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |