CTRI Number	CTRI/2020/05/025209 [Registered on: 15/05/2020] Trial Registered Prospectively
Last Modified On:	02/02/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	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 Modification(s)	AN OPEN LABEL RANDOMISED CONTROL TRIAL ON PASSIVE IMMUNIZATION WITH CONVALESCENT PLASMA IN SEVERE COVID-19 DISEASE
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dipyaman Ganguly  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 Contact Person Scientific Query	Name  Yogiraj Ray  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 Contact Person Public Query	Name  Dipyaman Ganguly  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 Modification(s)	No of Sites = 1   Contact Person  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   9434649592 rimbisss@yahoo.co.in
Details of Ethics Committee Modification(s)	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 Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent Modification(s)	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 Modification(s)	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 Modification(s)	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 Modification(s)	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"
Phase of Trial	Phase 2
Date of First Enrollment (India) Modification(s)	20/05/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="7" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NA
Brief Summary Modification(s)	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.