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CTRI Number  CTRI/2020/06/026222 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intravenous Immunoglobulin Therapy in the treatment of Moderate Pneumonia in COVID-19 patients 
Scientific Title of Study   A Phase II Safety and Efficacy Study on prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
VB-N-IVIG-COVID-19/2020-CT2; version 2 date 20.05.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Himanshu 
Designation  Prinicipal investigator 
Affiliation  Associate Professor 
Address  King Georges Medical University
Kings George Medical University, Shahmina Road, Chowk, Lucknow. (UP)
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839266822  
Fax    
Email  dr.himanshu.reddy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrHemanth Nandigala 
Designation  Manging Director 
Affiliation  Virchow Biotech Private Limited 
Address  Room Number 1, East Avenue Buliding, plot number 319 and 320,AyyappaSociety
Madhapur
Hyderabad
TELANGANA
500018
India 
Phone  04023119481  
Fax  040231194816  
Email  hnandigala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditi 
Designation  Manging Director 
Affiliation  Manging Director 
Address  Room Number 1, Biosite Research Pvt Ltd 740, 2nd Floor,
14th Main Road, Kumarswamy Layout, Bangalore -560078.
Bangalore
KARNATAKA
560078
India 
Phone  9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Virchow Biotech Private Limited East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad, Telangana,India-500081 
 
Primary Sponsor  
Name  Virchow Biotech Private Limited 
Address  Virchow Biotech Private Limited East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad,Telangana,India-500081 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Giridhar Patil  Belagavi Institution Of Medical Sciences  Department of Medicine, Belagavi Institution Of Medical Sciences, Dr. B. R. Ambedkar Road, Belagavi – 590 001 Karnataka, India Belgaum KARNATAKA
Bangalore
KARNATAKA 
9845111575

drgiridharpatil@gmail.com 
Dr Anil Kumar  GANDHI MEDICAL COLLEGE AND HOSPITAL   Room No 201, Department of General Medicine, 2nd Floor, Gandhi Hospital, Musheerabad, Secunderabad, Telangana, India. 500003
Hyderabad
TELANGANA 
9440523902

anilddrmd@gmail.com 
Dr D Himanshu  King Georges Medical University  Department of Medicine Kings George Medical University, Shahmina Road, Chowk, Lucknow. (UP)
Lucknow
UTTAR PRADESH 
9839266822

dr.himanshu.reddy@gmail.com 
Dr R S Raman  Maharaja Agrasen Hospital  Room N0.1, Department of medicine No. 35, New Rudrapur, Punjabi Bagh, Punjabi Bagh West, Delhi - 110026
West
DELHI 
91-11-40777777

dr.rs.raman.2005@gmail.com 
Dr Arun Dewan  Max Smart Super Speciality Hospital,   Press Enclave Marg, Saket District Centre, Saket, New Delhi, Delhi 110017
New Delhi
DELHI 
8826628182

shaitansinghgupta@gmail.com 
DrVijay Barge  Rajarshi Chhatrapati Shahu Maharaj government medical college and CPR Hospital  Department of Medicine Dasara Chowk Kolhapur
Kolhapur
MAHARASHTRA 
9011066766

vijaybarge6766@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
IEC Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee GANDHI MEDICAL COLLEGE AND HOSPITAL   Submittted/Under Review 
Institutional Ethics Committee, Kings George Medical University  Approved 
Institutional Ethics Committee, KLE University  Submittted/Under Review 
Max Healthcare Ethics Committee  Submittted/Under Review 
Om Sai OncoInstitutional EthicsCommittee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Immunoglobulin and standard of care  Dose:0.4 g/kg body weight Frequency once in a day Duration 5 days Route IV route 
Comparator Agent  Standard of Care  Azithromycin 500 mg once a day for 5 days Lopinavir/ritonavir 200 mg/50 mg - two tablets every 12 h for 14 days or for seven days after becoming asymptomatic, whichever is earlier; and (ii) For patients who are unable to take medications by mouth, 400 mg lopinavir /100 mg ritonavir 5 ml suspension every 12 h for 14 days or seven days after becoming asymptomatic whichever is earlier Piperacillin + Tazobactam 4.5 mg in 100 ml NS three times a day for 5 days Paracetamol 1gm tablet thrice a day; Pantocid 40 mg tablet once a day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Both male or female patients who signed the informed consent and aged ≥18 years ;
Patients admitted with RT-PCR confirmed COVID-19 illness.
Patient with any of the following :
Fever ≥36.7℃ axilla or Oral temperature ≥ 38.0 ℃
PaO2/ FiO2: 100-300 mmHg
Respiratory Rate >24/min and SaO2 90- 93% on room air
Lung involvement confirmed with chest X-ray.
(X-ray interpretation as mentioned in ICMR guideline-bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules)
 
 
ExclusionCriteria 
Details  Viral pneumonia with other viruses besides COVID-19
Patients are not suitable for immunoglobulin therapy.
Patients with severe pneumonia defined as : RR ≥ 30 times/min or oxygen saturation ≤ 90% in resting state or PaO2/FiO2 ≤ 100 mmHg or respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with prescence of other organ failure.
Patients on either immunoglobulin or hydroxychloroquine treatment
Pregnant or lactating women or other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
Participation in other studies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of days to clinical improvement.
It is defined as no. of days from initiation of treatment day to discharge day on a six-category ordinal scale
 
0-28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Time to clinical improvement
Number of deaths during the follow-up of 28 days (28 days mortality).
Incidence or duration of mechanical ventilation from day 0 to 28
Duration of hospitalization from day 0 to 28.
Incidence and duration of stay in ICU from day 0 to 28.
Proportion of patients with negative RT-PCR on day 14, on day 28 (or end of the study period).

 
0-28 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   29/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   Eligible patients will receive either IVIG + standard of care or standard of care alone as per the randomization. All the patients will be followed up for 28 days and their outcomes will be measured at schedule time points.
 
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