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CTRI Number  CTRI/2020/05/025299 [Registered on: 21/05/2020] Trial Registered Prospectively
Last Modified On: 22/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Convalescent Plasma treatment trial in COVID 19 patients 
Scientific Title of Study   Convalescent Plasma to Limit Coronavirus Associated Complications: An Open label Clinical Study of Anti-SARS-CoV-2 Plasma in Hospitalized Patients with COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
WH-CP-02-21;Amendment 02;26 Apr 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Behram Shawak Pardiwalla 
Designation  HOD Medicine and Head Academics 
Affiliation  Wockhardt Hospitals 
Address  Wockhardt Hospitals, COVID ward, Department of Medicine,1877 Dr. Anandrao Nair Marg, Near Agripada, Mumbai-Central

Mumbai
MAHARASHTRA
400011
India 
Phone  919820058562  
Fax    
Email  doc_bsp@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashima Bhatia 
Designation  Senior Vice President-Global Clinical Development 
Affiliation  Wockhardt Limited  
Address  Wockhardt Towers, 1st Floor Bandra Kurla Complex

Mumbai
MAHARASHTRA
400051
India 
Phone  02226534444  
Fax    
Email  abhatia@wockhardt.com  
 
Details of Contact Person
Public Query  
Name  Dr AjayKumar R Yadav 
Designation  Medical Monitor  
Affiliation  Wockhardt Limited 
Address  Wockhardt Towers Bandra Kurla Complex

Mumbai
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  AjaykumarY@wockhardt.com  
 
Source of Monetary or Material Support  
Wockhardt Ltd. Wockhardt Limited Wockhardt Towers,1st Floor ,West Wing, Bandra Kurla Complex Mumbai – 400 051, India.  
 
Primary Sponsor  
Name  Wockhardt Ltd 
Address  Wockhardt Limited Wockhardt Towers,1st Floor ,West Wing, Bandra Kurla Complex Mumbai – 400 051, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Behram Shawak Pardiwalla  Wockhardt Hospital Pvt Ltd  COVID ward,Department of Medicine, 1877 Dr. Anandrao Nair Marg, Near Agripada
Mumbai
MAHARASHTRA 		 9820058562

doc_bsp@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Wockhardt Hospitals Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Convalescent Plasma  SARS-CoV-2 convalescent plasma (single unit; additional unit will be given only if required based on subject’s clinical status) 
Comparator Agent  COVID Standard treatment  As per Revised Guidelines on ClinicalManagement of COVID – 19; Government of India Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division);31st March 2020 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Male or female, aged between 18 to 75 years (both inclusive)
2.Hospitalized with RT-PCR confirmed COVID-19 illness and has any one of the below mentioned two:
PaO2/ FiO2 <300
Respiratory Rate > 24/min and SaO2 < 93% on room air
3.Subject or LAR agree to provide a signed written informed consent prior to any study specific procedures and also agree to comply with study requirements
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1.Receipt of pooled immunoglobulin in past 30 days
2.Contraindication to transfusion or history of prior reactions to transfusion blood products
3.Critically ill patients:
PaO2/ FiO2 ratio <200 (moderate - severe ARDS)
Shock

4.Participating in any other clinical trial
5.Clinical status precluding infusion of blood products

6.Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Avoidance of progression to severe ARDS   day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in symptoms and radiological findings
2.Change and duration of RT-PCR test turning negative
3.Change in anti-SARS-CoV-2 titers pre and post plasma transfusion
4.Evaluate hospital and ICU mortality and length of stay
5.Evaluate duration and type (invasive or non-invasive) of ventilation support needed
6.28 days mortality
 		 28 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) 28/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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)?  

Response - NO
Brief Summary
Modification(s)  		 Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and the related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. 
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