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CTRI Number  CTRI/2020/04/024775 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 08/07/2020
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 efficacy and safety of convalescent plasma in moderate COVID-19 disease. 
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 in Moderate Disease.  
Trial Acronym  PLACID 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol v 1.1 dated 12/04/20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Mukherjee 
Designation  Scientist E 
Affiliation  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  aparna.sinha.deb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anup Agarwal 
Designation  Consultant 
Affiliation  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  8582932607  
Fax    
Email  mailanupagarwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anup Agarwal 
Designation  Consultant 
Affiliation  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  8582932607  
Fax    
Email  mailanupagarwal@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  Indian Council Of Medical Research 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 52  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravindra Singh  Aditya Birla Memorial Hospital  Aditya Birla Hospital Marg, Thergaon, Pimpri-Chinchwad, Maharashtra 411033
Pune
MAHARASHTRA 
9011352331

Rpsingh008@gmail.com 
Dr Neha Singh  AIIMS Patna   Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR 
9993028936

drnehasingh@aiimspatna.org 
Dr Archana Bajpayee  All India IAll India Institute of Medical Sciences Jodhpur  Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 
8003996943

drarchanabajpai@yahoo.co.in 
Dr Nitin M Nagarkar  All India Institute of Medical Sciences Raipur  Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
07712572999

director@aiimsraipur.edu.in 
Dr Nalini Kadgi  B.J. Government Medical College,  Jai Prakash Narayan Road, Railway Station Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA 
9423007898

deanbjmcpune@gmail.com 
Dr K J Upadhyay  B.J. Medical College and Civil hospital,  Asarwa, Ahmedabad, Gujarat, 380016
Ahmadabad
GUJARAT 
9825362253

drkjupadhyay@hotmail.com 
Dr Ravi K  Bangalore Medical College and Research Institute  Krishna Rajendra Rd, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 
9845128212

ravikdoc@gmail.com 
Dr Ajay Goenka  Chirayu Medical College and Hospital Bhopal  Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh 462030
Bhopal
MADHYA PRADESH 
9826040230

ajaygoenkachirayu@gmail.com 
Dr Joy John Mammen  Christian Medical College Vellore  IDA Scudder Rd, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU 
9655503150

joymammen@cmcvellore.ac.in 
Dr Nimisha Sharma  ESIC Medical College  NH-3, NIT Behind BK Hospital, Haryana 121012
Faridabad
HARYANA 
9650682846

nims427@gmail.com 
Dr CH Shrinivasa Rao  ESIC, Hyderabad  Sanath Nagar, Hyderabad 500038
Hyderabad
TELANGANA 
8106033420

srinivasarao.ch@esic.nic.in 
Dr Simmi Dube  Gandhi Medical College Bhopal  Sultania Rd, near Hamidia Hospital, Royal Market, Medical College Campus, Kohefiza, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH 
9479554822

simmi33@gmail.com 
Dr Raja Rao  Gandhi Medical College Secunderabad  Gandhi Hospital, Musheerabad, Padmarao Nagar, Secunderabad, Telangana 500003
Hyderabad
TELANGANA 
9849010915

dr.mrrao@gmail.com 
Dr Varsha Yogesh Godbole  GMERS Medical College, VAdodara  Old TB hospital Campus, Gotri Rd, Gotri, Vadodara, Gujarat 390021
Vadodara
GUJARAT 
9879181673

drvgodbole@gmail.com 
Dr Saurabh Srivastava  Government Institute of Medical Sciences Greater Noida   Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH 
9654233158

saurabhsrivas@gmail.com 
Dr Sunil Panjwani  Government Medical College Bhavnagar  Bus Stand, near State Road Transport Corporation, Panwadi, Bhavnagar, Gujarat 364001
Bhavnagar
GUJARAT 
9825331039

spanjwani0@gmail.com 
Dr Sushant Meshram  Government Medical College Nagpur  Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni, Nagpur, Maharashtra 440003
Nagpur
MAHARASHTRA 
9860990379

drsushant.in@gmail.com 
Dr Tinkle Patel  Government Medical College Surat  Opp. Income Tax Department Office, Majura Gate, Surat, Gujarat 395001
Surat
GUJARAT 
9898713223

pateltinkal@yahoo.com 
Dr Chennaveerappa PK  Hassan Institute of Medical Sciences  Hassan Institute of Medical Sciences, Sri Chamarajendra Hospital Campus, Krishnaraja Pura, Hassan, Karnataka 573201
Hassan
KARNATAKA 
9480303972

drchennamd@yahoo.com 
Dr B Abhishek  Jawaharlal Institute of Postgraduate Medical Education & Research Puducherry  Jipmer Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 
9008255888

drabhigowda@gmail.com 
Dr Ram Kalgud  Karnataka Institute of Medical Sciences Hubli  PB Rd, Vidya Nagar, Hubli, Karnataka 580022
Dharwad
KARNATAKA 
9844426887

drkaulgud.kims@gmail.com 
Himanshu Reddy  King George Medical University Lucknow  Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 
9839266822

placid2020kgmu@gmail.com 
Dr K Narasmhulu  Kurnool Medical College.  Near Bhudawarapet Bharath Petroleum, Kisan Ghat Rd, Kurnool, Andhra Pradesh 518002
Kurnool
ANDHRA PRADESH 
8978285266

nara17kg@gmail.com 
Dr Anil Gurtoo  Lady Hardinge Medical College Delhi  Connaught Place, New Delhi, Delhi 110001
Central
DELHI 
9810255153

anilgurtoo2@gmail.com 
Dr Niteen Karnik  Lokmanya Tilak Municipal General Hospital.  Dr Babasaheb Ambedkar Rd, RB2 Central Railway Quarters, Sion West, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA 
9821483404

drndkarnik@hotmail.com 
Dr B Latha  Madras Medical College  Near Park Town, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU 
9840313152

latsbalu@yahoo.co.uk 
Dr M Natrajan  Madurai Medical College  Collector Office Road Near, Alwarpuram, Madurai, Tamil Nadu 625020
Madurai
TAMIL NADU 
9842150275

laknataj@yahoo.com 
Dr Ram Manohar Jaiswal  Mahatma Gandhi Medical College and Hospital Jaipur  Tonk Rd, near India International School, Ricco Industrial Area, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN 
09602779900

drrmjaiswal@mgumst.org 
Dr Millind Baldi  Mahatma Gandhi Memorial Medical College Indore  AB Rd, CRP Line, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH 
9869393107

milindbaldi@gmail.com 
Dr Shivakumar KM  Mandya Institute of Medical Sciences  Mandya Institute of Medical Sciences, Bangalore-Mysore Road, Mandya, Karnataka 571401
Mandya
KARNATAKA 
9448345267

pulseshivu@yahoo.com 
Dr J Inbanthan  Mysore Medical College  Mysuru, Karnataka India 57000
Mysore
KARNATAKA 
9448051826

jinathan2008@gmail.com 
Dr Arti Trivedi  PDU Government Medical College  Jam Tower, Jamnagar Road Opp, Chawk, Kothi Compound, Rajkot, Gujarat 360001
Rajkot
GUJARAT 
9824206541

aartitrivedi@gmail.com 
Dr Vrushali Khadke  Poona Hospital and Research Centre  Shivam, 27, Shivram Matre Rd, Nr. Alka Talkies, Ganjwe Wadi, Sadashiv Peth, Pune, Maharashtra 411030
Pune
MAHARASHTRA 
9822407783

vgkhadke@gmail.com 
Dr Pankaj Malhotra  Postgraduate Institute of Medical Education and Research Chandigarh  Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 
7087009680

malhotrapankaj@hotmail.com 
Dr A Murali  PSG Institute of Medical Sciences & Research Coimbatore  Avinashi Rd, Peelamedu, Anna Nagar, Coimbatore, Tamil Nadu 641004
Coimbatore
TAMIL NADU 
9941356856

Muralimd2000@gmail.com 
Dr Manju Purohit  R D Gardi Medical College  Ujjain, Madhya Pradesh 456001
Ujjain
MADHYA PRADESH 
7987114919

manjuraj.purohit64@gmail.com 
Dr Varun Ashok Bafna  Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Kolhapur  Shenda Park Rd, Shenda Park, Kolhapur, Maharashtra 416013
Kolhapur
MAHARASHTRA 
9422415378

drvarunbafna6@gmail.com 
Dr Kiran Chaudhary  Ram Manohar Lohia Hospital  Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI 
9560095404

drchaudharyk@yahoo.co.in 
Dr Anjali Sharma  Safdarjung Hospital.  Ring Road,Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI 
9560109165

anjalisharmapath@gmail.com 
Dr Anupam Verma  Sanjay Gandhi Postgraduate Institute of Medical Sciences  New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH 
9415419882

aver2211@gmail.com 
Dr Aikaj Jindal  Satguru Pratap Singh Hospital Ludhiana  Grand Trunk Rd, Sherpur Chowk, Sherpur, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 
9803002423

drjindalaikaj@gmail.com 
Dr Jayashree Sharma  Seth Gordhandas Sunderdas Medical College (GSMC) and the King Edward Memorial Hospital  Acharya Donde Marg, Parel Mumbai 400012
Pune
MAHARASHTRA 
8080034525

jayashreesharma@kem.edu 
Dr Vivek Kumar  Sir H. N. Reliance Foundation Hospital and Research Centre Mumbai  , Prarthana Samaj, Raja Rammohan Roy Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA 
9833731099

Vivek57.kumar@rfhospital.org 
DR Sunita Bundas  SMS Medical College Hospital,Jaipur  Department of Immunohematology and Transfusion Medicine, Jaipur
Jaipur
RAJASTHAN 
9414045723

drsunitabundas@yahoo.in 
Dr Sreepad M Bhat  Smt Kashibai Navale Medical College  S.No. 49/1, Off Mumbai - Pune Bypass, Narhe, Pune, Maharashtra 411041
Pune
MAHARASHTRA 
9850470067

smb.med@gmail.com 
Dr J R Khambolja  Smt NHL Municipal Medical College  Department of Medicine, Ellisbridge, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT 
9825447813

kham_jak@yahoo.co.in 
Dr Ravi Dosi  Sri Aurobindo Institute of Medical Sciences  Indore - Ujjain State Highway, near MR 10, Crossing, Indore, Madhya Pradesh 453555
Indore
MADHYA PRADESH 
7869036808

ravi.dosi@gmail.com 
Dr Sreedhar Babu  Sri Venkateswara Institute of Medical Sciences  Alipiri Road, Tirupati, Chittoor District, Andhra Pradesh- 517507
Chittoor
ANDHRA PRADESH 
9494403546

kinneravsb@gmail.com 
Pramod R Jha  Sumandeep Vidyapeeth and Institution and Dhiraj Hospital  At & Po. Pipariya, Taluka Waghodia, Dist, Gujarat 391760
Vadodara
GUJARAT 
9426256118

dr.pkrnj@gmail.com 
Dr Satyam Arora  Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida  Indergarhi, Sector 30, Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH 
9971107774

satyamarora83@gmail.com 
Dr S A Manimala  Tirunelveli Medical College Hospital  High Ground Rd, Palayamkottai, Tirunelveli, Tamil Nadu 627011
Tirunelveli
TAMIL NADU 
9843193801

dr.sa.manimala@gmail.com 
Dr Rosemarie D Souza  TMC & BYL Nair Hospital Kasturba Hospital Mumbai  Dr. A. L. Nair, Road,Mumbai - 400008
Mumbai
MAHARASHTRA 
9820056230

drrosemariedesouza@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 52  
Name of Committee  Approval Status 
ABVIMS & Dr.RML Hospital  Approved 
Aditya Birla Memorial Hospital Pune  Approved 
AIIMS Patna  Approved 
AIIMS RAIPUR  Approved 
All India Institute of medical science ,Jodhpur  Approved 
B.J. Government Medical College,Pune  Approved 
B.J. Medical College and Civil Hospital, Ahmedabad  Approved 
Banglore Medical College and Research Institute   Approved 
Christian Medical College Vellore  Approved 
ESIC Hyderabad  Approved 
Gandhi Medical College, Bhopal  Approved 
Gandhi Medical College, Bhopal  Approved 
Gandhi Medical College, Secunderabad  Approved 
GMERS Vadodara  Approved 
Government Institute of Medical Sciences, Gr Noida  Approved 
Government Medical College, Bhavnagar  Approved 
Government Medical College, Surat  Approved 
Government Medical college. Hanuman Nagar,Nagpur  Approved 
HIMS Hassan  Approved 
Institutional Ethics Committee SMS Jaipur  Approved 
JIPMER  Approved 
Karnataka Institute of Medical Sciences, Hubli  Approved 
King george medical University Lucknow  Approved 
Kurnool Medical College kurnool andhra pradesh  Approved 
LHMC Delhi  Approved 
Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
Madras Medical College.Chennai  Approved 
Madurai Medical College, Madurai.  Approved 
Mahatma Gandhi Medical College and Hospital,Jaipur  Approved 
Mahatma Gandhi Memorial Medical College, Indore  Approved 
MIMS Mandya  Approved 
Mysore Medical College  Approved 
P.D.U.Medical College, Rajkot  Approved 
Poona Hospital and Research Centre, Pune  Approved 
Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
PSG Institute of Medical Sciences & Research  Approved 
R.D.Gardi Medical College , Ujjain  Approved 
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur  Approved 
SAIMS Hospital ,Indore (M.P)  Approved 
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow  Approved 
Satguru Pratap Singh Hospital, Ludhiana  Approved 
Seth GS Medical College and KEM Hospital,Mumbai , Maharastra   Approved 
Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai  Approved 
Smt .Kashibai Navale Medical College and General Hospital   Approved 
Smt NHL Municipal Medical College, Ahmedabad  Approved 
sri venkateswara institute of medical science   Approved 
SSPH Noida  Approved 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
T.N. Medical College & BYL Nair Hospital  Approved 
Tirunelvelli Medical College   Approved 
Translational health science and technology institute   Approved 
VMMC and Safdurjung MC  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   Convalescent plasma, 2 doses of 200 mL each, from recovered COVID-19 patient. 
Comparator Agent  Usual care for COVID-19 disease  Usual care for COVID-19 disease 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients admitted with RT-PCR confirmed COVID-19 illness.
2. Age > 18 years
3. Has any of the two
a. PaO2/ FiO2: 200-300
b. Respiratory Rate > 24/min and SaO2 < 93% on room air
4. Availability of matched donor plasma at the point of enrolment
 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Breastfeeding women
3. Known hypersensitivity to blood products
4. Receipt of pooled immunoglobulin in last 30 days
5. Critically ill patients:
a. P/F ratio <200 (moderate - severe ARDS)
b. Shock
6. Participating in any other clinical trial
7. Clinical status precluding infusion of blood products
 
 
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 avoidance of -
1. Progression to severe ARDS (P/F ratio 100) or
2. All-cause Mortality at 28 days
 
28 days from intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to symptom resolution
a. Fever
b. Shortness of Breath
c. Fatigue
 
1,3,5,7,14 days 
Length of hospital stay  Length of hospital stay 
Change in SOFA pre and post transfusion  0,1,3,5,7,14 
Change in oxygen requirement post transfusion  0,1,3,5,7,14 
5. Duration of respiratory support required
a. Duration of Invasive Mechanical Ventilation
b. Duration of Non-Invasive
 
5. Duration of respiratory support required
a. Duration of Invasive Mechanical Ventilation
b. Duration of Non-Invasive
 
Radiological improvement  0,3,7 days 
Adverse events (AE) associated with transfusion  Adverse events (AE) associated with transfusion 
To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR transfusion]  Days 0, 3, and 7  
Correlation between viral neutralization titer and Elisa antibody assay in donor plasma   Correlation between viral neutralization titer and Elisa antibody assay in donor plasma  
Correlation between IgG antibody in donor plasma and recipient plasma after transfusion.  0, 1,3,7 
Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusion  0, 3 
Need of Vasopressor use  Need of Vasopressor use 
Pre and post transfusion antibody titers (IgG) in recipient plasma


 
0,3,7 days 
 
Target Sample Size   Total Sample Size="452"
Sample Size from India="452" 
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)   22/04/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
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). Although not completely understood, multiple pathophysiological mechanisms have been hypothesized for the cause of mortality in COVID-19. Currently, there are no approved treatments for COVID-19. Multiple trials are being done across the globe to assess the efficacy of various treatment strategies. In 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.We hypothesize that the use of convalescent plasma will limit the progression of disease in patients with moderate COVID-19 infection. we plan to conduct a multi-center randomized controlled trial to test this hypothesis. The patients included will be those with RT-PCR confirmed COVID-19 illness, Age > 18 years, Has any of the two: a. PaO2/ FiO2: 200-300 b. Respiratory Rate > 24/min and SaO2 < 93% on room air;  Availability of matched donor plasma at the point of enrolment. After obtaining informed consent and randomization, the intervention arm will receive 2 doses of 200mLeach of convalescent plasma along with usual care whereas the control group will receive usual care for COVID-19. The primary outcome is a composite measure of the avoidance of- Progression to severe ARDS (P/F ratio <100) or all-cause mortality at 28 d


 
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