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CTRI Number  CTRI/2021/12/038622 [Registered on: 14/12/2021] Trial Registered Prospectively
Last Modified On: 14/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Immunological therapy]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The use of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin in patients with COVID 19 - a trial to know its efficacy and safety 
Scientific Title of Study   An International Multicenter, Adaptive, Randomized Double-Blind, Placebo- Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19 
Trial Acronym  ITAC 
Secondary IDs if Any  
Secondary ID  Identifier 
INSIGHT 013 Version No. 1.0  Protocol Number 
NCT04546581  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Mukherjee 
Designation  Medical Scientist E 
Affiliation  Indian Council of Medical Research 
Address  Clinical Trial & Health Systems Research Unit Epidemiology and Communicable Diseases Division ICMR, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  aparna.sinha.deb@icmr.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jerin Jose Cherian 
Designation  Medical Scientist D 
Affiliation  Indian Council of Medical Research 
Address  Division of Basic Medical Sciences, ICMR, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  cherian.jj@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Jerin Jose Cherian 
Designation  Medical Scientist D 
Affiliation  Indian Council of Medical Research 
Address  Division of Basic Medical Sciences, ICMR, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  cherian.jj@icmr.gov.in  
 
Source of Monetary or Material Support  
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) 
 
Primary Sponsor  
Name  University of Minnesota 
Address  Minneapolis, MN 55455, United States 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH  5601 Fishers Ln, Rockville, MD 20852, United States 
 
Countries of Recruitment     Denmark
Greece
Japan
Nigeria
Spain
United Kingdom
United States of America
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Kumar  All India Institute of Medical Science, Jodhpur  Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 9116396922

deepak1007sharma@gmail.com 
Dr Nusrat Shafiq  Post Graduate Institute of Medical Education and Research, Chandigarh  Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 0172-2755555

nusrat.shafiq.pgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
All India Institute of Medical Science, Jodhpur, Institutional Ethics Committee  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
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  Anti SARS CoV-2 Hyperimmune Intravenous Immunoglobulin  Anti-Coronavirus Hyperimmune IVIG contains polyvalent antibodies with neutralizing specificity for SARS-CoV-2. It has the potential to provide a standardized therapy to augment host immunity to SARS-CoV-2 and prevent disease progression in symptomatic patients. Hyperimmune IVIG differs from standard IVIG in its derivation from donors who have mounted an immune response to the infection of interest (natural infection as undertaken in this protocol, or following vaccination for other disease states), and its standardization as a product based on neutralizing antibody titers or similar assays demonstrating its activity against the infection of interest. Hyperimmune globulin requires plasma from otherwise healthy individuals in the convalescent phase of the infection, and it is clear that there will be many individuals fitting this criterion with most patients recovering from COVID-19 and therefore able to safely provide a plasma donation during convalescence. Therefore, this resource will be rapidly available and will serve as an accessible therapeutic modality across multiple jurisdictions globally 
Comparator Agent  Placebo  Participants assigned to the placebo group for hIVIG will be given infusions of a commercially available isotonic saline solution. There are color differences between the infusion preparations for hIVIG and placebo. Therefore, site pharmacists will be instructed to place a colored sleeve or other suitable covering over all infusion bags to mask the color of the contents and reduce the risk of unblinding. The volume used for hIVIG and for placebo will be comparable. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. SARS-CoV-2 infection documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
2. Symptomatic COVID-19 disease
3. Duration of symptoms attributable to COVID-19 ≤ 12 days
4.Requiring in patient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
5.Age ≥ 18 years
6. Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
7. Provision of informed consent by participant or legally authorized representative

 
 
ExclusionCriteria 
Details  1.Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
3.Current or predicted imminent (within 24 hours) requirement for any of the following:
• Invasive ventilation
• Non-invasive ventilation
• Extracorporeal membrane oxygenation
• Mechanical circulatory support
• Continuous vasopressor therapy
4. History of allergy to IVIG or plasma products
5. History of selective IgA deficiency with documented presence of anti-IgA antibodies
6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
• Includes New York Heart Association Class III or IV stage heart failure
7. Any of the following thrombotic or procoagulant disorders:
• Acute coronary syndromes, cerebrovascular syndromes and pulmonary or
deep venous thrombosis within 28 days of randomization
• History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
8.Any condition for which in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications.
 		 On Days 1, 2, 3, 7, and 28 
 
Secondary Outcome  
Outcome  TimePoints 
Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups can be compared for multiple outcomes, and results can be compared or combined with other trials.  The time points for the secondary outcome is day 28. Delayed outcome will be measured on day 90. 
 
Target Sample Size   Total Sample Size="500"
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/10/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient. 
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