| CTRI Number |
CTRI/2020/06/026123 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 21 |
| 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 Namita Padwal |
LTM Medical College & General Hospital |
Department of Medicine, Room no. 1, College building, 1st floor, Dr. Babasaheb Ambedkar Road, Sion ,Mumbai-400022.
Mumbai
MAHARASHTRA |
9819484830
njpadwals@yahoo.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= 21 |
| 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 Human Research, LTM Medical college & Hospital, Sion, Mumbai |
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |