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 Biological |
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 |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
ITOLI-C19-02-I-00, V3.0, 09/04/2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Millind Nadkar |
Address |
Seth G S Medical College and KEM Hospital, Parel Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
milindnadkar@yahoo.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Subramanian Loganathan |
Address |
Biocon Biologic India Limited, Biocon House, Semicon Park Electronics City Phase 2
Bangalore 560100 Karnataka India
Bangalore KARNATAKA 560100 India |
Phone |
08028085305 |
Fax |
08028085000 |
Email |
subramanian.l101@biocon.com |
|
Details Contact Person Public Query
|
Name |
Sivakumar Vaidyanathan |
Address |
Biocon Biologic India Limited Biocon House Semicon Park Electronics City Phase 2
Bangalore 560100 Karnataka India
Bangalore KARNATAKA 560100 India |
Phone |
|
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
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 4 |
Contact Person |
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 |
9810977901
anjantrikha@hotmail.com |
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 |
9891158991
drskumar31@yahoo.co.in |
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
Mumbai |
9820060705
milindnadkar@yahoo.com |
Dr Rosemari De Souza |
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, |
Dr. A. L. Nair Road,
Mumbai - 400008 Mumbai |
9820056230
drrosemariedesouza@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
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
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
Patients |
Respiratory conditions due to other external agents |
|
Intervention / Comparator Agent
Modification(s)
|
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.
|
|
ExclusionCriteria |
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
Modification(s)
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
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
• NIV
• IMV
• HFNO
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
Modification(s)
|
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" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/05/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None Yet |
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. |