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CTRI Number  CTRI/2020/05/025209 [Registered on: 15/05/2020] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Convalescent Plasma Transfusion]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease 
Scientific Title of Study   AN OPEN LABEL RANDOMISED CONTROL TRIAL ON PASSIVE IMMUNIZATION WITH CONVALESCENT PLASMA IN SEVERE COVID-19 DISEASE 
Trial Acronym  PICP19 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipyaman Ganguly 
Designation  Principal Scientist 
Affiliation  CSIR-Indian Institute of Chemical Biology 
Address  CSIR-Indian Institute of Chemical Biology 4 Raja S.C. Mullick Road Jadavpur

Kolkata
WEST BENGAL
700032
India 
Phone  9831460046  
Fax    
Email  dipyaman.iicb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yogiraj Ray 
Designation  Assistant Professor 
Affiliation  Calcutta School of Tropical Medicine 
Address  108, Chittaranjan Ave, Calcutta Medical College, College Square, Kolkata, West Bengal 700073

Kolkata
WEST BENGAL
700073
India 
Phone  9830126060  
Fax    
Email  jaggs.nbmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dipyaman Ganguly 
Designation  Principal Scientist 
Affiliation  CSIR-Indian Institute of Chemical Biology 
Address  CSIR-Indian Institute of Chemical Biology 4 Raja S.C. Mullick Road Jadavpur

Kolkata
WEST BENGAL
700073
India 
Phone  9831460046  
Fax    
Email  dipyaman.iicb@gmail.com  
 
Source of Monetary or Material Support  
Council of Scientific and Industrial Research Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg, New Delhi – 110001 
 
Primary Sponsor  
Name  Council of Scientific and Industrial Research 
Address  Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg, New Delhi – 110001 
Type of Sponsor  Government funding agency 
 
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 Biswanath Sharma Sarkar  ID and BG Hospital COVID Hospital  57, Beleghata Main Rd, Subhas Sarobar Park, Phool Bagan, Beleghata, Kolkata, West Bengal 700010
Kolkata
WEST BENGAL 
9434649592

rimbisss@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, ID and BG Hospital, Kolkata  Approved 
Institutional Ethics Committee, Medical College Hospital, Kolkata  Approved 
The Ethical Committee on Human Subjects, CSIR-Indian Institute of Chemical Biology, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Passive Immunization using Convalescent Plasma in COVID-19  Blood group matched convalescent Plasma (COVID Plasma) from recovered COVID-19 patients will be transfused to patients with severe COVID-19 diseases 200ml COVID Plasma will be intravenously transfused once daily on two consecutive days. 
Comparator Agent  Standard of care  Standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients admitted with RNA PCR proven COVID-19 with
severe disease (fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2< 90% at room air)
with Mild ARDS (200 mmHg < PaO2/FiO2 ≤ 300 mmHg, with PEEP or CPAP ≥5 cm H2O, or non-ventilated)
or Moderate ARDS (100 mmHg < PaO2/FiO2 ≤200 mmHg, with PEEP ≥5 cm H2O, or non-ventilated)
within 5 to 10 days from initial presentation.
 
 
ExclusionCriteria 
Details  1. Pregnant mothers
2. Patients with age less than 18 years
3. Admitted late after 10 days of initial presentation
4. Patients refusing consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
2. To compare ‘all cause’ mortality
3. To identify the immune correlates for response to plasma therapy.
 
1. Discharge
2. Discharge/death
3. Day 0, Day 3, Day 7 after admission 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare recovery from ARDS in both groups
2. To compare time taken to negative viral RNA PCR
3. Adverse reaction to plasma therapy 
At discharge/death 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   20/05/2020 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Brief Summary  

The coronavirus disease (COVID-19) caused by the novel coronavirus SARS-CoV2 has spread globally, with confirmed infected cases crossing 4.5 million worldwide resulting in more than 300,000 fatalities. On 11th of March, 2020, the World Health Organization (WHO) has declared COVID-19 to be a pandemic and research laboratories all over the world are working towards developing a vaccine and other therapeutic interventions. Passive immunization using convalescent plasma is an age-old therapeutic strategy in infections for which no vaccine or drugs with roven efficacy are available. Our aim is to study convalescent plasma therapy in an open label randomised control trial, which involves administration of plasma from patients who have recovered from COVID-19 infection to patients with severe COVID-19 disease, with or without mild or moderate acute respiratory distress syndrome. Primary objectives of this trial will be, 1) to compare progression to severe Acute Respiratory Distress Syndrome between two groups, 2) to compare ‘all cause’ mortality, 3) to identify the immune correlates for response to plasma therapy. Secondary outcomes are, 1) to compare recovery from acute respiratory distress syndrome in both groups, 2) to compare time taken to negative viral RNA PCR, 3) to document any adverse reaction to plasma therapy.

 
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