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CTRI Number  CTRI/2020/06/026123 [Registered on: 24/06/2020] Trial Registered Prospectively
Last Modified On: 10/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Plasma therapy in corona patients(Severe COVID-19). 
Scientific Title of Study   A phase II, Open label, randomized controlled trial to assess the safety and efficacy of convalescent plasma in severe COVID-19. 
Trial Acronym  PLATINA TRIAL. 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushant Meshram  
Designation  Prof. and Head of Dept. of Pulmonary Medicine. 
Affiliation  government medical college and hospital Nagpur 
Address  Dept of Pulmonary Medicine, 4th floor Super Specialty Hospital Government Medical College Hospital Nagpur

Nagpur
MAHARASHTRA
440009
India 
Phone  9860990379  
Fax    
Email  drsushant.in@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushant Meshram  
Designation  Prof. and Head of Dept. of Pulmonary Medicine. 
Affiliation  government medical college and hospital Nagpur 
Address  Dept of Pulmonary Medicine, 4th floor, Super Specialty Hospital, Government Medical College Hospital, Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9860990379  
Fax    
Email  drsushant.in@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushant Meshram  
Designation  Prof. and Head of Dept. of Pulmonary Medicine. 
Affiliation  government medical college and hospital Nagpur 
Address  Dept of Pulmonary medicine, 4th floor, Super Specialty Hospital, Government Medical College Hospital, Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9860990379  
Fax    
Email  drsushant.in@gmail.com  
 
Source of Monetary or Material Support  
Dr Sanjay Mukherjee Secretary Medical Education and Drug Department 9th floor G T Hospital campus, new Mantralya, Mumbai Govenrnment of Maharashtra  
 
Primary Sponsor  
Name  Dr Sushant Meshram 
Address  Dept of Pulmonary Medicine, 4th floor Super specialty Hospital Government Medical College Nagpur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Shejwal  BHMC Dhule  Dept of Pathology, BHMC Chakkarbardi, Malegaon Road Samta Nagar Dhule Maharashtra 424001 India
Dhule
MAHARASHTRA 
9890607987

sbhgmc@sbhgmcdhule.org 
Dr Rohidas Borse  BJGMC PUNE  Dept of Medicine,B J Govt Medical College and Sassoon General Hospitals College of Nursing Jai Prakash Narayan Road, Near Pune Railway Station, Pune 411001 Fax 91 20 26126868
Mumbai
MAHARASHTRA 
9923912525

deanbjmcpune@gmail.com 
Dr Shivkumar kori  EGMC & CSM Hospial, Thane  Department of Pathology, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane-400605
Thane
MAHARASHTRA 
9757223723

drsrk65@gmail.com 
Dr Vidya Nagar  GGMC Mumbai  Dept of Medicine, Grant Government Medical College and Sir J.J. Group of Hospitals,JJ Marg, Nagpada-mumbai Central, Near Sandhurst Road and J J Police Station, Mumbai – 400008 EMail : deangmcjjh@rediffmail.com
Mumbai
MAHARASHTRA 
9665803241

deangmcjjh@rediffmail.com 
Dr Sunita Ade  GMC Akola  Dept of Medicine, GOVERNMENT MEDICAL COLLEGE, AKOLA - 444 001, MAHARASHTRA STATE
Akola
MAHARASHTRA 
9822726129
07242437078
dean@gmcakola.in 
Dr Minakshi Bhattacharya  GMC Aurangabad  Dept of Medicine, Government Medical College, Near Panchakki Road Aurangabad. Pin 431001
Aurangabad
MAHARASHTRA 
9922931527
02402402418
deangmca@gmail.com 
Dr Sanjay Chawhan  GMC Gondiya  Dept of Pathology, Government Medical College Near Indira Gandhi Stadium Neharu Chowk Gondia
Gondiya
MAHARASHTRA 
9823642628

gmcgondiya@gmail.com 
Dr Vijay Gaikwad  GMC Jalgaon  Dept of Medicine, Govt. Medical College, Civil Hospital Campus, Jalgaon
Jalgaon
MAHARASHTRA 
9922274644

deangmcjalgaon@gmail.com 
Dr Maroti Karale  GMC Latur  Dept of Medicine Government Medical College and Hospital Mataji Nagar, Moti Nagar, Latur, Maharashtra 413512
Latur
MAHARASHTRA 
8291384004

dean_gmchl@rediffmail.com 
Dr Anita Basavaraj  GMC Miraj and Sangli  Dept of Medicine, Govt Medical College, Pandharpur Road, Miraj, Dist Sangli Pincode 410410 Maharashtra
Sangli
MAHARASHTRA 
9423576044

deangmcmiraj@yahoo.co.in 
Dr D P Bhurke  GMC Nanded  Dept of Medicine Dr Shankararo Govt Medical College and Hospital Vishnupuri Nanded 4531 606 Maharashtra
Nanded
MAHARASHTRA 
9420264084

gmcnanded@rediffmail.com 
Dr Prasad Potdukhe  GMC, Chandrapur  Dept of Medicine, Govt Medical College T B Hospital Campus Ramnagar Chandrapur Phone 07172 252522
Nagpur
MAHARASHTRA 
9766915047

gmcchandrapur@gmail.com 
Dr Sushant Meshram  GMC, Nagpur  Dept of Pulmonary medicine Government Medical College Near Hanuman Nagar Nagpur- 440009. Email Id :drsushant.in@gmail.com, deangmc2@gmail.com Fax : 0712-2744489
Nagpur
MAHARASHTRA 
9860990379

drsushant.in@gmail.com 
Dr Radha Munje  IGGMC,Nagpur  Dept of Pulmonary Medicine, Indira Gandhi Government Medical College and Hospital, C.A. Road, Nagpur
Nagpur
MAHARASHTRA 
9422147752
07122728028
igmcn@rediffmail.com 
Dr Mahendrakumar V Bansode  RCMS Kolhapur  Dept of Medicine RCSM Medical College CPR Hospital Kolhapur Bhausinghaji Road,Dasara Chowk Kolhapur District Maharashtra State INDIA 416002
Kolhapur
MAHARASHTRA 
7385190923

rcsmlib@yahoo.in 
Dr Kavita Joshi   SGSMC & KEM Hospital   Department of Medicine, Old Hospital building, second floor, Acharya Dhonde Marg, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 
9869788359

kavitajoshi@kem.edu 
Dr Sheshrao S Chavan  SRTR Ambejogai  Dept of Medicine, SRT Medical College Dr B R Ambedkar Rd Ambajogai Maharashtra 431517
Bid
MAHARASHTRA 
8788923645

srtrgmc@gmail.com 
Dr Seema Kini  TNMC and BYL Nair CH Hospital  Dr AL Nair Road, Mumbai Central East Mumbai 400008
Mumbai
MAHARASHTRA 
9819195078

shkini@gmail.com 
Dr Anita Bandichhode  VMMC Solapur  Dept of Medicine, VMMC Opp. District Court, Solapur-413003, MAHARASHTRA,INDIA 0217 2749401, 0217 2319448 0217 2310766
Solapur
MAHARASHTRA 
9423593139

deansolapur@gmail.com 
Dr Baba Yelke  VNGMC Yavatmal  Dept of Medicine, VNGMC, Waghapur Road, Palswadi Camp, Civil Lines, Yavatmal, Maharashtra 445001
Yavatmal
MAHARASHTRA 
9822569223
244148
deanvngmc@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
GMC Akola ethics committee  Approved 
GMCYIEC, Yavatmal  Approved 
ICEC Rajiv Gandhi Medical College & CSMH, Thane  Approved 
IEC , SGMC & KEM Hospital, Mumbai  Approved 
IEC Dept of pharmacology,GGMC Mumbai  Approved 
IEC Dept. of Pharmacology Govt Medical College Nagpur  Approved 
IEC GMC Gondiya  Approved 
IEC GMC Latur  Approved 
IEC GMCH,Miraj and PVPGH sangli  Approved 
IEC TNMC and BYL Nair CH Hospital, Mumbai  Approved 
IEC, BHMC, Dhule  Approved 
IEC, BJGMC,Pune  Approved 
IEC, GMC Jalgaon  Approved 
IEC, GMC Nanded  Approved 
IEC, GMC,Chandrapur  Approved 
IEC, RCMS,Kolhapur  Approved 
IEC,GMCA, Aurangabad  Approved 
IEC,IGGMC Nagpur  Approved 
IEC,VMGMC Solapur  Approved 
IEC. SRTR Ambejogai  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, J128||Other viral pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Convalescent plasma   Anti SARS COV 2 convalescent plasma viral neutralizing antibodies blood product two doses of 200 ml transfusion 24 hours apart 
Comparator Agent  Standard of Care  Standard of Care as per guidelines of Directorate Medical Education,Govt of Maharashtra,which includes antibiotics,steroid,LMWH,HCQ,Oxygen Support. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Hospitalized COVID-19 patients, Fever Cough breathlessness plus one or more of the following respiratory rate more than 30 per minutes, O2 saturation less than 90%, PaO2 by FiO2 less than 300. Patients with Comorbidities Viz.DM,COPD,HTN,Asthma included.  
 
ExclusionCriteria 
Details  Pregnant and Breast Feeding Females, Critically ill patients viz. Severe ARDS,Sepsis,Septic shock MODS,Coronary artery disease,arrhythmia Heart Failure. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients showing at least 2 points clinical improvement on WHO ordinal scale at 28 days post randomization.
All cause mortality at 28 days 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Time to clinical improvement.
Length of hospital stay.
Change in SOFA score.
Duration of oxygen support.
Duration of respiratory support required.
Levels of biomarkers CRP Ferritin,D Dimer pre and posttransfusion.
Radiological improvement.
 
28 days 
 
Target Sample Size   Total Sample Size="472"
Sample Size from India="472" 
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)   25/06/2020 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   This is a phase 2 open label randomized controlled trial to assess the safety and efficacy of Convalscent plasma in severe COVID19, which will be conducted in 21 sites in Maharashtra, State of India.Primary outcome measures will be clinical improvement on WHO ordinal scales of atleast 2 points and all cause mortality at 28 days.The secondary outcomes will be time to clinical improvement, length of hospital stay, Change in SOFA score, Duration of oxygen support, duration of respiratory support and radiological improvement at 28 days. 
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