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CTRI Number  CTRI/2020/04/024804 [Registered on: 22/04/2020] Trial Registered Prospectively
Last Modified On: 16/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of safety and efficacy of convalescent plasma in COVID-19 patients 
Scientific Title of Study
Modification(s)  		 Open Label, parallel arm, phase I/II clinical trial to evaluate Safety and efficacy of Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
IMD/CoV/003/2020, Version 2.1, 29 Apr 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Rao 
Designation  Principal Investigator 
Affiliation  HealthCare Global Enterprises Ltd. 
Address  9/1, Kalinga Rao Road, Sampangi Rama Nagara, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9739774949  
Fax    
Email  drvishal.rao@hcgel.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyothnsa Rao 
Designation  Co-Investigator 
Affiliation  International Stemcell Services Ltd 
Address  9/1, Kalinga Rao Road, Sampangi Rama Nagara, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9620252285  
Fax    
Email  jyotrao@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CRO representative 
Affiliation  Trial Guna 
Address  681, 17th Cross Road, JP Nagar 6th Phase, KR Layout, Bengaluru, Karnataka- 560078

Bangalore
KARNATAKA
560078
India 
Phone  9972636265  
Fax    
Email  regulatory@trialguna.com  
 
Source of Monetary or Material Support  
International Stemcell Services Ltd 
 
Primary Sponsor  
Name  International Stemcell Services Ltd 
Address  Tower 5, 9/1, Mission Road, Sampangi Rama Nagar, Bangalore-560027  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Dhoot  H.C.G Bangalore Institute of Oncology Speciality Centre  HCG Cancer Center Tower 4, 2nd Floor, Room no. 221, 8 HCG Towers, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore-560027
Bangalore
KARNATAKA 		 9042815404

dr.adhoot@gmail.com 
Dr Ramesh Revanna  Victoria Hospital- BMCRI  Room No- 2, 1st floor, Next to the Deans chamber,Fort Rd, near City Market, New Tharagupet, Bengaluru, Karnataka, 560002
Bangalore
KARNATAKA 		 9341229228

ramesh2reva@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College & Research Institute  Approved 
HCG Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
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
Modification(s)  
Type  Name  Details 
Intervention  convalescent plasma  Arm A Subjects will be administered about 500 ml of apheresis derived Convalescent plasma intravenously in a single dose along with standard care of therapy 
Comparator Agent  standard care of therapy  In Arm B the standard care will be as per the local hospital protocol and as per recommendations/guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - 18 years and older (male or female)
- Laboratory confirmation of COVID – 19
- CT image is characteristic of 2019 novel corona virus pneumonia (optional)
- Sign a consent form and follow the test plan and follow-up process.

Inclusion criteria for donors of plasma
- 18 years and older (male or female)
- Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge.
- COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample.
- The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis).
- Sign a consent form and follow the test plan and follow-up process.

 
 
ExclusionCriteria 
Details  - Patients with autoimmune disease in the past or screening
- Those who have serious disease that affect their overall survival as decided by the treating clinican
- Self reports HIV or syphilis infected persons
- Pregnant or lactating women
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months.

Exclusion criteria for donors
- Patients who become sick again after getting discharged
- RNA positive for COVID or TTI positive.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Safety, efficacy.
Side effects measured by Chest Radiograph.
Improvement of clinical symptoms including duration of fever, respiratory distress, pneumonia, cough, sneezing, and diarrhea within 3 days of the convalescent plasma transfusion.
Oxygen Saturation, Pao2/Fio2.
Decrease in viral load as detected by PCR, serum antibody titer.
Routine blood biochemical parameters including renal and liver function tests.
Sequential Organ Failure Assessment (SOFA)  		 Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14
Eg. CT chest- Day -2, Day 3, Day 7 and Day 14
Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14
Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
- Rate of mortality
- Marker of immunological function, ferritin, CRP, d-dimer
- Ventilatory and extracorporeal membrane oxygenation (ECMO) supports before and after treatment 		 All parameters will be assessed on Day 0, Day 1, Day 3, Day 14.
d-dimer assessed on Day 0, Day 1, Day 3, Day 14 and Day 28. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)
Modification(s)  		 11/05/2020 
Date of Study Completion (India) 23/10/2020 
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   To be filled 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Background:
COVID-19 is a condition caused by infection with Corona Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates, causing a worldwide pandemic. The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel corona virus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Corona viruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.
Purpose:
The objective of this study is to investigate the potential use of convalesecent plasma in patients with Corona Virus SARS-CoV-2 infection.
 
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