| CTRI Number |
CTRI/2021/04/032531 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial to Compare effects and safety of Etanercept in Patients with Moderate COVID-19 |
|
Scientific Title of Study
|
A Phase II, Multi-Centre, Double Blind, Randomized, Comparative Study to Evaluate Efficacy and Safety of Etanercept in Patients with Moderate COVID-19 (COVETA) |
| Trial Acronym |
COVETA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LRP/ETN/2020/001 Version 3.0 dated 04.03.2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Director |
| Affiliation |
Lupin Limited |
| Address |
1st Floor, A Wing Green Building, NDDD Department, Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
020-66749068 |
| Fax |
|
| Email |
chiragshah@lupin.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelakant Krishnan |
| Designation |
Assistant Director |
| Affiliation |
Lupin Limited |
| Address |
1st Floor, A Wing Green Bldg, NDDD Dept. Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
020-66749892 |
| Fax |
|
| Email |
neelakantkrishnan@lupin.com |
|
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Source of Monetary or Material Support
|
| Lupin Limited
Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune MAHARASHTRA 412115 India Pune MAHARASHTRA 412115 India |
|
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Primary Sponsor
|
| Name |
Lupin Limited |
| Address |
Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune MAHARASHTRA 412115 India Pune MAHARASHTRA 412115 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Deshpande |
Ashirwad Hospital & Research Centre |
Research room, ground floor, Maratha Section, Near Jijamata Udyan, Ulhasnagar-421004
Thane
MAHARASHTRA |
9822017445
writetoshrikant@rediffmail.com |
| Dr Ramshyam C Agarwal |
Gunjkar Multispeciality Hospital |
COVID Department, OPD no. 03, 1st Floor, Gunjkar Multispeciality Hospital, Plot No. 315, Sec 18, Spine road, Shivtej Nagar, PCMC, Chikhali, Pune 411019
Pune
MAHARASHTRA |
8087282022
ramshyamagarwal20@gmail.com |
| Dr Ram S Kaulgud |
Karnataka Institute of Medical Sciences |
Ward no 303 and 304, Department of Medicines, PB Road, Vidyanagar, Hubli
Dharwad
KARNATAKA |
9844426887
drkaulgud.kims@gmail.com |
| Dr Arun Dewan |
Max Smart Super Speciality Hospital |
Room no. 2, First floor, Mandir Marg, Press Enclave Road, Saket, New Delhi
New Delhi
DELHI |
9810091290
dewanarun40@gmail.com |
| Dr Atul Gogia |
Sir Ganga Ram Hospital |
Department of Medicine, 4th Floor, room no F-46, SGRH Marg, Rajinder Nagar, New Delhi
New Delhi
DELHI |
9891003450
atulgogs@gmail.com |
| Dr Vinayak Maruti Sawardekar |
St Georges Hospital Grant Government Medical College & Sir JJ Group of Hospitals, Mumbai |
Medicine Department, 02 Floor, P DMello Road, CST, Mumbai 400001, Maharashtra, India.
Mumbai
MAHARASHTRA |
9820747703
vinayaks1812@gmail.com |
| Dr Hamsraj Alva |
Vinaya Hospital and Research Centre |
Research Room, 3rd Floor, polyclinic building Karangalpady, Mangaluru
Dakshina Kannada
KARNATAKA |
9343562622
hansalva2001@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Ethics Committee KIMS Hubli |
Approved |
| Ethics Committee Vinaya Hospital |
Approved |
| Institutional Ethics Committee Grant Government Medical College, Mumbai |
Approved |
| Institutional Ethics Committee Sai Sneh Hospital & Diagnostic Centre |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lupin Etanercept |
Etanercept 50mg PFS dose subcutaneously on day 1 and Etanercept 25mg PFS subcutaneously on day 4 |
| Comparator Agent |
Placebo |
Placebo 50mg PFS dose subcutaneously on day 1 and Placebo PFS dose 25mg subcutaneously on day 4 |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients 18-65 years of age or older
2. Willing and able to provide written informed consent prior to performing study procedures
3. Confirmed SARS-CoV-2 infection within 10 days as determined by RT-PCR with presence of clinical features such as dyspnea and or hypoxia, fever, cough, SpO2 <94% (range 90-94%) on room air
4. Have indicators of risk of progression: at least 1 inflammatory marker (e.g. D-dimer, IL6, CRP, ferritin, TNF) ≥2 × upper limit of normal (ULN)
5. Females of childbearing potential must have a negative serum pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 3 months following last dose of study drug |
|
| ExclusionCriteria |
| Details |
1. Require invasive mechanical ventilation
2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 × ULN o Creatinine >1.5 × ULN
3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB
5. Known case of hepatitis B, hepatitis C or HIV infection.
6. Known hypersensitivity to etanercept or any component of the formulation
7. Patients having received Remdesivir prior to screening
8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry
9. Participation in any other clinical trial of an experimental treatment for COVID-19
10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with clinical improvement (defined as ≥2 points reduction on WHO Ordinal Scale) |
Day 14 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with clinically significant reduction in biomarkers: D-dimer, CRP, IL-6, ferritin, TNF. |
Day 4, 7 and 14 from baseline |
| Change in levels of biomarkers (D-dimer, C-reactive protein, IL-6, ferritin, TNF) |
Day 4, 7 and 14 |
| Duration of hospitalization |
complete |
| Time to clinical improvement measured using WHO Ordinal Scale (defined as ≥2 points improvement) |
Day 14 |
| Proportion of patients with clinical improvement (defined as ≥2 points reduction on WHO Ordinal Scale) |
Day 7 |
| Time to clinical recovery |
Day 14 |
| Proportion of patients requiring mechanical ventilation |
Day 14 |
| All cause mortality |
complete |
| Safety endpoints: Proportion of patients experiencing Treatment-Emergent Adverse Events |
Day 14 |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) including secondary bacterial infection |
Day 14 |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
12/04/2021 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a Phase II, multi-centre, double blind, randomized, comparative study designed to evaluate efficacy and safety of etanercept as an add-on therapy to Remdesivir in moderate COVID-19 patients. Approximately 50 patients are planned to be enrolled in the trial. Etanercept is already approved in India for treatment of several auto-immune and inflammatory disorders. The efficacy and safety of Etanercept in COVID-19 is not yet established. Therefore, this study is designed to explore efficacy and safety of Etanercept in moderate COVID-19 patients. |