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CTRI Number  CTRI/2020/04/024915 [Registered on: 29/04/2020] Trial Registered Prospectively
Last Modified On: 05/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications 
Scientific Title of Study   A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MHC-COVID-19-CP, Version 2.0 dated 20-Apr-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sangeeta Pathak 
Designation  Senior Consultant & Head –Blood Bank 
Affiliation  Blood Bank, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) 
Address  Max Super Speciality Hospital (Devki Devi Foundation), East Block, Blood Bank, 2, Press enclave Road, Saket New Delhi

New Delhi
DELHI
110017
India 
Phone  9873081647  
Fax    
Email  sangeeta.pathak@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta Pathak 
Designation  Senior Consultant & Head –Blood Bank 
Affiliation  Blood Bank, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) 
Address  Max Super Speciality Hospital (Devki Devi Foundation), East Block, Blood Bank, 2, Press enclave Road, Saket New Delhi

New Delhi
DELHI
110017
India 
Phone  9873081647  
Fax    
Email  sangeeta.pathak@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Rajesh Saxena 
Designation  General Manager- Office of Research 
Affiliation  Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) 
Address  Max Super Speciality Hospital (Devki Devi Foundation), East Block, Service Floor, 2, Press enclave Road, Saket New Delhi

New Delhi
DELHI
110017
India 
Phone  9818474003  
Fax    
Email  rajesh.saxena@maxhealthcare.com  
 
Source of Monetary or Material Support  
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) 
 
Primary Sponsor  
Name  Max Super Speciality Hospital A Unit of Devki Devi Foundation 
Address  Max Super Speciality Hospital Devki Devi Foundation 2, Press enclave Road, Saket New Delhi – 110017 
Type of Sponsor  Private hospital/clinic 
 
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 Sangeeta Pathak  Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)  Max Super Speciality hospital A unit of Devki Devi Foundation, 2, Press enclave Road, Saket New Delhi – 110017
New Delhi
DELHI 
9873081647

sangeeta.pathak@maxhealthcare.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee  Approved 
Institutional Ethics Committee  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  Convalescent Plasma  200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the therapy 
Comparator Agent  Standard care of treatment  control group will be treated as per Standard care of treatment. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients admitted with RT-PCR confirmed COVID-19 illness.
2. Age > 18 years
3. Written informed consent
4. Has any of the two
a. PaO2/ FiO2 <300
b. Respiratory Rate > 24/min and SaO2 < 93% on room air 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Breastfeeding women
3. Known hypersensitivity to blood products
4. Receipt of Pooled Immunoglobulin in last 30 days
6. Participating in any other clinical trial
7. Clinical status precluding infusion of blood products 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is a composite measure of the avoidance of -
1. Progression to severe ARDS (P/F ratio 100) and
2. All-cause Mortality at 28 days  
one year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to symptom resolution-Fever,Shortness of Breath,Fatigue
2. Hospital length of stay
3. Change in SOFA pre and post transfusion
4. Duration of respiratory support required
5. Radiological improvement
6. Adverse events (AE) associated with transfusion
7. To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion]
8. Levels of bio-markers pre and post transfusion
9. Need of Vasopressor use
 
one year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/05/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary   The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by  the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infectionsIn a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage. 

The study will be conducted over the period of one year on 100 Hospitalized, COVID-19 patients, fulfill the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilities in Max healthcare Hospital will be eligible for inclusion in the trial. This Phase II, open label, randomized controlled trial. Consecutive patients meeting the inclusion–exclusion criteria and providing informed consent will be randomly assigned to the test and the control group using random numbers generated by randomization.com. Patients in the test group will receive convalescent plasma and the control group will be on standard care.
 
COVID-19 convalescent plasma will be collected from recovered individuals if they are eligible to donate blood. For infusion of plasma existing SOP of the wards w.r.t transfusion of FFP should be followed with special care to monitor these patients during and post-24 hours of transfusion. An ABO compatible plasma bag of approx. 200ml will be issued maintaining all the blood bank records after thawing at 37 degree Celsius. The first plasma transfusion may be followed by one or two additional doses of 200 ml at 24 hours interval according to disease severity and tolerance of the infusions.


Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome – based on whether the composite primary end point is met or not. Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.


Eligibility of Potential Donor

1. Only males and nulliparous female donors of weight > 55 kgs will be included.

2. Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs & Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination. 

3. Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation & departmental SOPs.

4. In addition to the aforementioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP).

  Blood group and antibody screening – Antibody screen positive donors will be deferred.
  Complete blood count including Hb, Hct, Platelet count, Total and differential leucocyte count. Donors with Hb>12.5g/dl, platelet count >1, 50,000 per microliter of blood and TLC within normal limits will be accepted.
  Screening for HIV, HBV and HCV by serology and NAT. Donor negative by both the tests will be included.
  Screening for syphilis and malaria by serology. Negative donors will be included
  Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020)
  Titration of anti-COVID-19 (both IgG and IgM) antibodies and SARS- CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using ELISA. If not done at the time of plasma collection the donor samples will be stored in aliquots at <-80° C to be tested at a later date.

  Molecular test for COVID-19 either from nasopharyngeal swab specimens or blood may be done depending on availability of tests. Donors positive will be deferred. 



 
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