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CTRI Number  CTRI/2021/05/033622 [Registered on: 14/05/2021] Trial Registered Prospectively
Last Modified On: 14/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Plasma therapy (IgG) in moderate to severe COVID-19 patients 
Scientific Title of Study   A Randomized, Open-label Parallel Group Study to Evaluate Efficacy and Safety of Intravenous Immunoglobulin (IVIG) in Hospitalized patients with COVID-19  
Trial Acronym  IVIG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M K Daga 
Designation  Director – Professor 
Affiliation  Maulana Azad Medical College 
Address  129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604273  
Fax    
Email  drmraduldaga@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M K Daga 
Designation  Director - Professor 
Affiliation  Maulana Azad Medical College 
Address  129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604273  
Fax    
Email  drmraduldaga@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Govind Mawari 
Designation  Scientist B 
Affiliation  Maulana Azad Medical College 
Address  129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968829919  
Fax    
Email  sonumawari@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and Associated Hospitals 
 
Primary Sponsor  
Name  Lok Nayak Hospital 
Address  Jawaharlal Nehru Marg, near Delhi Gate, LNJP Colony, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M K Daga  Maulana Azad Medical College  129, Department of Medicine, B.L Taneja Block, Maulana Azad Medical College associated L. N Hospital
Central
DELHI 
9968604273

drmraduldaga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC associated Hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Intravenous Immunoglobulin (IVIG)   400mg /kg b.w. per day for 5 days 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female subjects in between 18 years to 65 years
1. Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 ≤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes. (As per MoHFW)
2. Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. (As per MoHFW)
 
 
ExclusionCriteria 
Details  Known hypersensitivity to immunoglobulin.
History or presence of any disorder that increases the safety risk of the patient as per investigator discretion.
History of DVT, PE, thromboembolic stroke or other thrombotic events.
Active participant in another research treatment study.
Pregnancy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatment  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in oxygen saturation by pulse oximetry. All-cause mortality till day 60
Mean Number of days of hospitalization.
Number of days of mechanical ventilation
Proportion of patient with fever at each visit
Time required to RT-PCR negative
Safety (Number of AEs, SAEs, Infusion reactions) (Additional endpoints requiring investigations CT Score, Severity of pneumonia can be added –will depend upon clinical set up. 
3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   21/05/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be conducted by the Lok Nayak Hospital, New Delhi. The study subjects will be enrolled from the population of moderate to severe COVID-19 positive cases requiring BiPAP support and who are willing to be a part of the study. For the study, a total of 60moderate to severe COVID-19 positive subjects would be recruitedwhich would be further divided into two treatment arms; the first treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with standard treatment + Intravenous Immunoglobulin (IVIG) drug at 400mg/kg/day for 5 days and the second treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with the standard treatment. Only the subjects (Male or Female) who are above the age of 18 would be included for the study. The criteria for the moderate and the severe illness in COVID-19 are as:-Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 ≤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes; Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.

All the subjects will be excluded if they have any of the following: Known hypersensitivity to immunoglobulin, History or presence of any disorder that increases the safety risk of the patient as per investigator discretion, History of DVT, PE, thromboembolic stroke or other thrombotic events, Active participant in another research treatment study andPregnancy.

The follow-ups will be done everyday till discharge and for day 30 and day 60 follow-up it can be telephonic. RT-PCR will be done at day 14 which will be repeated if negative. Day 0 follow-up will be considered as the baseline.

Safety Assessment Labs: (Screening/ Day 0, Day 5, Day 30 EOS Visit i.e., day 60) Haematology, Biochemistry (LFT, KFT, D-dimer, CRP, LDH, Urinalysis, ABG, SpO2). Safety lab assessment needs to be done at discharge. If discharge is within 7 days of scheduled safety assessment, the scheduled assessment can be skipped.

As per the investigator’s judgement Chest X ray, CT Scans (on day 30 and day 60) would be considered.

For statistical analysis data will be entered in excel sheet and analyzed using SPSS-PC25 version. Data will be expressed in proportions and relationship to immune status will be determined with co- morbid conditions, age and gender by Chi-square test. ‘p’ less than 0.05 will be considered as statistically significant.

A proper written informed consent will be obtained from all the study participants after explaining the study procedures along with benefits and risks of participation. Participation will be on voluntary basis. Privacy and confidentiality of data will be maintained.

 
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