FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037898 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 08/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of Tofacitinib plus standard of care vs. Standard of care alone for COVID pneumonia 
Scientific Title of Study   Randomized Controlled Trial of Tofacitinib versus Standard of Care Alone for COVID-19 Pneumonia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amitabha Sengupta 
Designation  Professor and Head 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Ground Floor, Department of Pulmnology, 244, A.J.C Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  drasengupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amitabha Sengupta 
Designation  Professor and Head 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Ground Floor, Department of Pulmnology, 244, A.J.C Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  drasengupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amitabha Sengupta 
Designation  Professor and Head 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Ground Floor, Department of Pulmnology, 244, A.J.C Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  drasengupta@gmail.com  
 
Source of Monetary or Material Support  
Institute of Postgraduate Medical Education and Research, 244, A.J.C Bose Road, Kolkata- 700020 
 
Primary Sponsor  
Name  Institute of Postgraduate Medical Education and Research 
Address  244, A.J.C Bose Road, Kolkata- 700020 
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 
Amitabha Sengupta  Institute of Postgradute Medical Education and Research  Ground Floor, Department of Pulmnology, 244, A.J.C Bose Road, Kolkata- 700020
Kolkata
WEST BENGAL 		 9433022613

drasengupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Oversight Committee, Institute of Postgraduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Standard of care  Standard of care 
Intervention  Tofacitinib  Tofacitinib 5mg BD for 14 days with standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  i. Adults of either sex with laboratory confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR)
ii. Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND hypoxia defined as room air saturation of <93% at admission
 
 
ExclusionCriteria 
Details  i. Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization
ii. History of or known current thrombosis
iii. Have a personal or first-degree family history of blood clotting disorders.
iv. Participants who are immunocompromised, with known immunodeficiencies
v. Participants with any malignancy
vi. Severe hepatic impairment, defined as Child-Pugh class C.
vii. Severe anemia (hemoglobin <8 g/dL).
viii. Absolute lymphocyte count <500 cells/mm;
ix. Absolute neutrophil count <1000 cells/mm.
x. Known allergy to Tofacitinib.
xi. Other medical or psychiatric condition
xii. Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19)
xiii. Have received any of these within 4 weeks prior to the first dose of study intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (e.g., Tocilizumab) or IL-1 inhibitors (e.g., anakinra) within the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
xiv. Have received treatment with corticosteroids equivalent to prednisone or methylprednisolone >20 mg/day for equal or more than 14 consecutive days prior to screening.
xv. Current participation in other trials
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects alive at day 14.  Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of subjects on supplemental oxygen but not needing any form of mechanical ventilation, or ECMO by day 14.
2. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
3. Not hospitalized and not requiring home oxygen at day 14
4. Number of days in hospital
5. Number of days in ICU
6. Number of patients who went on to require mechanical ventilation after admission.
 		 Day 14 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Rationale of the study –

Baricitinib, a JAK (Janus Kinase) inhibitor in combination with Remdesvir, was approved by the FDA in November, 2020 for COVID-19. However, the cost and availability limits the use of Baricitinib in India. To overcome this, Tofacitinib, an inhibitor of JAK 1 and 3 has been tried. In a single-centre retrospective study, Tofacitinib plus dexamethasone was compared with dexamethasone alone and a 70% reduction in odds of dying was observed in the combination group. This study aims to study the efficacy of Tofacitinib with standard of care versus standard of care alone in patients with COVID-19 pneumonia.

Relevance and expected outcome:

The second wave of COVID-19 has been devastating for India and mortality benefit of an oral, accessible drug is an unmet need. We expect that initiation of immunomodulatory therapy with Tofacitinib will lead to improved clinical outcome and reduce mortality. 

 
Close