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CTRI Number  CTRI/2020/05/024959 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On: 21/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and Safety of Itolizumab in COVID-19 Complications 
Scientific Title of Study   A Multi-Centre, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ITOLI-C19-02-I-00, V3.0, 09/04/2020  Protocol Number 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name  Dr Millind Nadkar 
Designation  Prof of Medicine 
Affiliation  Department of Medicine, Seth G S Medical College and KEM Hospital 
Address  Seth G S Medical College and KEM Hospital, Parel Mumbai 400012

Email  milindnadkar@yahoo.com  
Details of Contact Person
Scientific Query
Name  Dr Subramanian Loganathan 
Designation  General Manager 
Affiliation  Biocon Biologic India Limited 
Address  Biocon Biologic India Limited, Biocon House, Semicon Park Electronics City Phase 2 Bangalore 560100 Karnataka India

Phone  08028085305  
Fax  08028085000  
Email  subramanian.l101@biocon.com  
Details of Contact Person
Public Query
Name  Sivakumar Vaidyanathan 
Designation  General Manager 
Affiliation  Biocon Biologic India Limited 
Address  Biocon Biologic India Limited Biocon House Semicon Park Electronics City Phase 2 Bangalore 560100 Karnataka India

Fax  08028085000  
Email  sivakumar.vaidyanathan@biocon.com  
Source of Monetary or Material Support  
Biocon Biologics India Limited 
Primary Sponsor  
Name  Biocon Biologics India Limited 
Address  Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase - II, Hosur Road, Bengaluru, Karnataka – 560100 
Type of Sponsor  Pharmaceutical industry-Indian 
Details of Secondary Sponsor  
Name  Address 
Countries of Recruitment     India  
Sites of Study
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjan Trikha  All India Institute Of Medical Sciences,  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi

Dr Suresh Kumar  MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital  MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital, Jawaharlal Nehru Marg, Maulana Azad Medical College Campus, Delhi Gate, New Delhi, Delhi 110002
New Delhi

Dr Milind Nadkar  Seth GS Medical College and KEM Hospital   Department of Medicine Seth GS Medical College and KEM Hospital Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012

Dr Rosemari De Souza  Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,  Dr. A. L. Nair Road, Mumbai - 400008

Details of Ethics Committee
No of Ethics Committees= 4  
Name of Committee  Approval Status 
EC Seth GS Medical College and KEM Hospital, Mumbai  Approved 
IEC Topiwala National Medical College B. Y. L. Nair Charitable Hospital Mumbai 400008  Approved 
IEC, MAMC, New Delhi 11002  Approved 
Institute Ethics Committee, AIIMS, New Delhi  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, (2) ICD-10 Condition: J70||Respiratory conditions due to other external agents,  
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm A Best supportive care with Itolizumab  Start at 1.6 mg/kg dose iv infusion, if well tolerated and improvement in patient observed, investigator has the discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen. 
Comparator Agent  Arm B Best supportive care  By best supportive care” which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy, will be administered. The best supportive care will be as per institution standard 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female adults above 18 years (not tested in children yet)
2. Informed consent for participation in the study
3. Virological diagnosis of SARS-CoV2 infection (PCR)
4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection
5. Oxygen saturation at rest in ambient air ≤94%
6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200 or
more than 25% detoriation from the immediate previous value.
Details  1. Known severe allergic reactions to monoclonal antibodies
2. Active tuberculosis (TB) infection
3. History of inadequately treated tuberculosis or latent tuberculosis
4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments
5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months
6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
8. Patients with known history of Hepatitis B, Hepatitis C or HIV
9. Absolute Neutrophils count (ANC) <1000 / mm3
10. Platelets <50,000 / mm3
11. Absolute Lymphocyte count (ALC): <500/mm3

Method of Generating Random Sequence
Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Outcome  TimePoints 
1 one month mortality rate
2 Proportion of pts with deterioration of lung function as measured by
• Stable SpO2; PaO2 without increasing FiO2
3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation
4 Reduction in proportion of pts who need
5 Time of duration of mechanical ventilation, for pts needing intubation
6 Change in inflammatory markers CRP, d-Dimer, ferritin

up to One-month
Secondary Outcome
Outcome  TimePoints 
Biomarkers (IL-6, TNF-a)   up to One-month 
Lymphocyte count  up to One-month 
PaO2 / FiO2 ratio   up to One-month 
Treatment-related side effects as assessed by CTCAE   up to One-month 
Radiological response  up to One-month  
Duration of hospitalization  up to One-month 
Remission of respiratory symptoms  up to One-month 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/05/2020 
Date of Study Completion (India) 07/07/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Recruitment Status of Trial (Global)
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a Multi-Centric, Open label, Two Arm Randomized, Pivotal Phase 2 Study.

All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with daily recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals –pulse, BP, RR; Temperature (highest temperature of the day), PaO2/FiO2, MAP, GCS.    

As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.