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CTRI Number  CTRI/2020/05/025328 [Registered on: 23/05/2020] Trial Registered Prospectively
Last Modified On: 26/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications 
Scientific Title of Study   To Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications 
Trial Acronym  COVID PLASMA STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. Covid 19, Version no 1.1, Dated 11 May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Chawla 
Designation  Senior Consultant Respiratory and Critical Care Medicine 
Affiliation  Indraprastha Apollo Hospitals 
Address  Indraprastha Apollo Hospitals Department of Respiratory and Critical care medicine Room no. 1223 Sarita Vihar Delhi Mathura Road New Delhi 110 076 India

New Delhi
DELHI
110076
India 
Phone  011-29871681  
Fax  011-41677024   
Email  drchawla@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Chawla 
Designation  Senior Consultant Respiratory and Critical Care Medicine 
Affiliation  Indraprastha Apollo Hospitals 
Address  Indraprastha Apollo Hospitals Department of Respiratory & Critical Care Medicine Room no 1223 Sarita Vihar Delhi Mathura Road New Delhi 110 076 India

New Delhi
DELHI
110076
India 
Phone  011-29871681  
Fax  011-41677024   
Email  drchawla@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Chawla 
Designation  Senior Consultant Respiratory and Critical Care Medicine 
Affiliation  Indraprastha Apollo Hospitals 
Address  Indraprastha Apollo Hospitals Department of Respiratory & Critical Care Medicine Room no. 1223 Sarita Vihar Delhi Mathura Road New Delhi 110 076 India

New Delhi
DELHI
110076
India 
Phone  011-29871681  
Fax  011-41677024   
Email  drchawla@hotmail.com  
 
Source of Monetary or Material Support  
Indraprastha Apollo Hospitals (a unit of Apollo Hospitals Enterprise Limited), , Mathura Rd, Sarita Vihar, New Delhi -110076 
 
Primary Sponsor  
Name  Apollo Hospitals Enterprise Limited 
Address  Indraprastha Apollo Hospitals (a unit of Apollo Hospitals Enterprise Limited), Mathura Rd, SaritaVihar, New Delhi -110076, Attn: Dr. Rajesh Chawla  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suresh Ramasubban  Apollo Gleneagles Hospitals  Department of Critical care & Respiratory medicine, Room no. 4, 58, Canal Circular Road kolkata 700054
Kolkata
WEST BENGAL 		 9831740837

drsuresh@hotmail.com 
Dr Suneetha Narreddy  Apollo Hospitals  Department of Infectious Disease, Room no. 48, Jubilee Hills Hyderabad 500096
Hyderabad
TELANGANA 		 9966022225

suneethanarreddy@gmail.com 
Dr Tushar Parmar  Apollo Hospitals  Department of Critical Care, 3rd Floor, ICU-A, Discussion room no. 1, 13# parsik hill road,off uran road, sector-23,CBD belapur, Navi Mumbai -400614
Mumbai
MAHARASHTRA 		 9820863981

drtushar_p@apollohospitals.com 
Dr D Suresh Kumar  Apollo Specialty Hospitals  Department of Infectious Disease, Room no. 13 Plot No 64, Vanagaram-Ambattur Rd, Ayanambakkam, Kil Ayanambakkam
Chennai
TAMIL NADU 		 9444186807

dskinfdis@gmail.com 
Dr Rajesh Chawla  Indraprastha Apollo Hospitals   Department of Respiratory & Critical Care Medicine, Room no. 1223, Mathura Rd, Sarita Vihar, New Delhi -110076,
New Delhi
DELHI 		 9810033395
011-41677024
drchawla@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee, Apollo Gleneagles Hospitals, Kolkata  Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals, Chennai  Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals, Hyderabad  Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals, Mumbai  Approved 
Institutional Ethics Committee-Clinical Studies, Indraprastha Apollo Hospitals, New Delhi  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   Convalescent plasma, two doses of 200 mL each. 
Comparator Agent  Routine standard of care treatment for COVID 19 disease   Routine standard of care treatment for COVID 19 disease 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Tested positive for COVID 19 by RT-PCR
2. Age > 18 years
3. Written and informed consent
4. Severe or Life threatening disease.

1. Severe disease is defined as: (one or more are present)
i. Dyspnea with oxygen saturation ≤ 93%,
ii. Respiratory frequency ≥ 30/min and oxygen saturation ≤ 93%,
iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
iv.Infiltrates on chest X-ray > 50% within 24 to 48 hours

2. Life-threatening disease is defined as: (one or more are present)

i. Respiratory failure needing invasive support
ii. Sepsis,
iii. Multiple organ dysfunction or failure
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to blood products
2. Receipt of Pooled Immunoglobulin in last 30 days
3. Participating in any other clinical trial
4. Contraindications to blood products
5. Pregnant or Breast feeding women
6. In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours.
7.On mechanical ventilation for more than 7 days
8.Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g. stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
9. Respiratory failure caused by illness other than SARS-CoV-2.
10 . Other documented uncontrolled infection
11. Severe DIC,TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate.
12. Active intracranial bleeding.
13. Clinically significant myocardial ischemia.

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is a composite measure of the

i. All-cause Mortality at 28 days
ii. Improvement of SOFA score Post transfusion

 		 28 days from intervention 
 
Secondary Outcome  
Outcome  TimePoints 
i.Time to symptom resolution a. Fever b. Shortness of Breath c. Fatigue
ii. Length of hospital stay.
iii. Change in oxygen requirement post transfusion.
iv.Decreased duration of respiratory support required
a. Duration of Invasive Mechanical Ventilation
b. Duration of Non-Invasive /HFNC
v. Radiological improvement
vii. Adverse events (AE) associated with transfusion
ix. Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusion
x.Need of Vasopressor use
 		 1,3,7,14,28 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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)?  

Brief Summary   World Health Organization declared the novel corona virus disease(COVID-19), to be a pandemic on 11th  March 2020 [1].  COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fever, cough, fatigue, sore throat, shortness of breath are common symptoms and nasal discharge, headache, nausea and diarrhea are less common symptoms of COVID- 19. The most common abnormalities in vital signs is increased temperature and tachypnea. Bilateral pulmonary infiltrates, ground glass opacities and consolidation are the common radiological abnormalities seen in these patients. The severe disease occurs in those who are elderly, diabetic, hypertensive, D- dimer levels raised, higher SOFA score, elevated IL-6, increased Lactate Dehydrogenase, hyperferritinemia and lymphopenia on admission[6,7]. The most common complications are sepsis, respiratory failure, acute respiratory distress syndrome (ARDS), cardiac involvement and acute kidney injury. The pathophysiological mechanisms responsible for this disease are not fully understood but many theories have been hypothesized for bad prognosis in COVID-19. At present, there are no approved treatments for COVID-19. The management plan is largely supportive with  symptomatics ,supplemental oxygen and noninvasive respiratory  support (Noninvasive ventilation, HFNC) and invasive mechanical ventilation. Various trials are being done across the globe to assess the efficacy of various treatment. US FDA has recently approved Convalescent Plasma from patients recovered from COVID-19 for the treatment of severe or life threatening COVID-19 infections. Five critically ill COVID-19 patients in a small case series with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma resulted in improvement in clinical status with no deaths and the study reported that three patients were discharged,whilst two continued to be stable on mechanical ventilation. We hypothesize that use of convalescent plasma will limit the progression of disease in Hospitalized COVID-19 patients with Severe or Life threatening disease. Therefore, we hereby plan to conduct a multicentric randomized controlled trial to test the hypothesis. RT-PCR confirmed Covid-19 postive patients > 18 years old, having severe or life threatening disease shall be enrolled in the study. After obtaining informed consent, patients will randomized either of two treatment groups (Intervention or control group). Intervention group will receive 2 doses of 200 ml each of convalescent plasma along standard of care treatment while control group will receive standard of care treatment alone. The primary outcome is a composite measure of the avoidance of all cause mortality at 28 days and worsening of SOFA score post transfusion.



 
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