| CTRI Number |
CTRI/2020/06/026222 [Registered on: 29/06/2020] Trial Registered Prospectively |
| Last Modified On: |
03/10/2020 |
| 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
|
|
|
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
|
|
|
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 |
| 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)= "103"
Final Enrollment numbers achieved (India)="103" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/06/2020 |
| Date of Study Completion (India) |
12/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|