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CTRI Number  CTRI/2020/04/024773 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 27/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effects of additional treatments for patients hospitalized and receiving treatment due to COVID -19. 
Scientific Title of Study   An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care 
Trial Acronym  SOLIDARITY TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
ISRCTN83971151  ISRCTN 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSheela Virendra Godbole 
Designation  Scientist F and Lead PI/National Co-Ordinator 
Affiliation  ICMR-National AIDS Research Institute, Pune 
Address  ICMR-National AIDS Research Institute, Pune G 73 BLOCK MIDC BHOSARI PUNE

Pune
MAHARASHTRA
411026
India 
Phone  09422087972  
Fax  27121071  
Email  sgodbole@nariindia.org  
 
Details of Contact Person
Scientific Query
 
Name  DrSheela Virendra Godbole 
Designation  Scientist F and Lead PI/National Co-Ordinator 
Affiliation  ICMR-National AIDS Research Institute, Pune 
Address  ICMR-National AIDS Research Institute, Pune G 73 BLOCK MIDC BHOSARI PUNE

Pune
MAHARASHTRA
411026
India 
Phone  09422087972  
Fax  27121071  
Email  sgodbole@nariindia.org  
 
Details of Contact Person
Public Query
 
Name  DrSheela Virendra Godbole 
Designation  Scientist F and Lead PI/National Co-Ordinator 
Affiliation  ICMR-National AIDS Research Institute, Pune 
Address  ICMR-National AIDS Research Institute, Pune G 73 BLOCK MIDC BHOSARI PUNE

Pune
MAHARASHTRA
411026
India 
Phone  09422087972  
Fax  27121071  
Email  sgodbole@nariindia.org  
 
Source of Monetary or Material Support  
World Health Organization and Indian Council of Medical Research 
 
Primary Sponsor  
Name  World Health Organization 
Address  Avenue Appia 20 Geneva 1211 Switzerland  
Type of Sponsor  Other [International Research Organization] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707 Fax: 91-11-26588662 Email:icmrhqds[at]sansad[dot]nic[dot]in 
 
Countries of Recruitment     Argentina
Brazil
Canada
Germany
India
Indonesia
Iran (Islamic Republic of)
Norway
Peru
Qatar
South Africa
Spain
Switzerland
Thailand  
Sites of Study
Modification(s)  
No of Sites = 29  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhir Bhandari  Sawai Man Singh Medical College Medical College & attached Hospitals, Jaipur  Jawahar Lal Nehru Marg, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN 
9829078844

drs_bhandari@yahoo.com 
Dr Rajnish Joshi  AIIMS,Bhopal  Saket nagar, Bhopal, Madhya Pradesh, 462024
Bhopal
MADHYA PRADESH 
9425303401

rajnish.genmed@aiimsbhopal.edu.in 
Dr Prasan Kumar Panda  All India Institute of Medical Sciences (AIIMS), Rishikesh  Virbhadra road, Shivaji Nagar Near Barrage, Sturida Colony Rishikesh, Uttarakhand India
Dehradun
UTTARANCHAL 
9868999488

prasan.med@aiimsrishikesh.edu.in 
DrNishant Kumar Chauhan  All India Institute of Medical Sciences, Jodhpur  "All India Institute Of Medical Sciences (AIIMS),Basni Industrial Area Phase-2, Jodhpur-342005, Rajasthan. "
Jodhpur
RAJASTHAN 
8003996884

nishant97@gmail.com 
Dr Manish Soneja   All India Institute of Medical Sciences,N. Delhi  Ansari Nagar N. Delhi 110029 AIIMS, New Delhi
New Delhi
DELHI 
9013074717

manishsoneja@gmail.com 
DrBharath Kumar Tirupakuzhi Vijayaraghavan  Apollo Hospitals Enterprises Limited  No-21 Greams Lane off Greams road Chennai Chennai Tamil Nadu - 600006 India
Chennai
TAMIL NADU 
9591100655

bharath@icuconsultants.com 
Dr D Suresh Kumar   Apollo Specialty Hospitals, Vanagaram, Chennai  Apollo Specialty Hospitals, Vanagaram, Chennai
Chennai
TAMIL NADU 
9444186807

dsk_1973@yahoo.com 
Dr Vikas Marwah  Army Institute of Cardio- thoracic Sciences (under AFMC)  Wanowrie, Pune - 411040
Pune
MAHARASHTRA 
9560503335

docvikasmarwah@gmail.com 
Dr Jignesh Shah  Bharati Vidyapeeth Deemed University Medical College  Room No 4, Pediatric OPD, Bharathi Hospital and Research Centre,Dhankawadi Katraj Pune
Pune
MAHARASHTRA 
9028246946

drshahjignesh78@gmail.com 
Dr Kamlesh Upadhyay  BJ Medical College and Civil Hospital AhmedabadGujrat  B.J. Medical College,New Civil Hospital Asarwa,Ahmedabad-380016,Gujarat,India
Ahmadabad
GUJARAT 
9825362253

drkjupadhyay@hotmail.com 
Dr Rohida Borse  BJ Medical College and Sasson General Hospital   Near Pune Railway Station
Pune
MAHARASHTRA 
9763201215

rohidas_borse@yahoo.co.in 
Dr Krishna Gopal Singh   Chirayu Medical College and Hospital  Chirayu Medical College & Hospital, Department of Pulmonary Medicine, Chirayu Medical College &Hospial, Bhainsakhedi, Near Biragarh, Bhopal-Indore highway, Bhopal, (M.P) - 462030
Bhopal
MADHYA PRADESH 
7566317444

dr.krishna2505@gmail.com 
Dr O C Abraham  Christian Medical College, Vellore  Vellore, Tamil Nadu PIN 632002
Vellore
TAMIL NADU 
9994068771

ocabraham@cmcvellore.ac.in 
Dr M Rajarao  Gandhi Medical College and Hospital  Musheerabad, Secunderabad, Hyderabad, Telangana - 500003 India
Hyderabad
TELANGANA 
9849010915

dr.mrrao@gmail.com 
Dr Chirag Rathod  GMERS Medical College & Hospital - Gotri  GMERS Medical College, Old TB Hospital Campus, Gotri, Vadodara, Gujarat - 390021
Vadodara
GUJARAT 
9173765727

chirag_rthd@rediffmail.com 
Dr R Narayana Babu  Goverment Medical College, Omandurar Goverment Estate, Chennai  Goverment Medical College, Omandurar Goverment Estate, Chenna
Chennai
TAMIL NADU 
9840426324

rameshkumar4v@yahoo.co.in 
Dr Dipti Chand  Government Medical College and Hospital, Nagpural  Medical College Square road, Nagpur - 440003
Nagpur
MAHARASHTRA 
9823257601

dachand.ngp@gmail.com 
Dr Krishnakant Bhatt  Government Medical College and New Civil Hospital, Surat  Outside Majura gate, Surat, Gujrat – 395 001
Surat
GUJARAT 
9825190476

knbsurat@gmail.com 
Dr Sheela Virendra Godbole  Lead Institute for this trial is ICMR-National AIDS Research Instiute   ICMR-National AIDS Research Institute, G 73 Block MIDC, Bhosari ,Pune 411026
Pune
MAHARASHTRA 
9422087972

sgodbole@nariindia.org 
Dr R Jayanthi  Madras Medical College & Rajiv Gandhi Government General Hospital  Poonamallee High Road, Park Town, Chennai, Tamil Nadu -600003
Chennai
TAMIL NADU 
9840025339

gghdean@gmail.com 
Dr Arun Dewan  Max Smart Super Speciality Hospital  Max Smart Super Speciality Hospital (A unit of Gujarmal Modi hospital and Research Centre of Medical Sciences) 1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
New Delhi
DELHI 
9810091290

Arun.Dewan@maxhealthcare.com 
Dr Zarir F Udwadia  P D Hinduja Hospital and Medical Research Centre  Unit of National Health & Education Society Veer Savarkar Marg, Mahim (West), Mumbai - 400016
Mumbai
MAHARASHTRA 
9820225309

zfudwadia@gmail.com 
Dr Aarti Trivedi  P D U Govt Medical College, Rajkot  Jamnagar Road, Rajkot
Rajkot
GUJARAT 
9824206541

aaratitrivedi@gmail.com 
Dr Pravin Soni  Pimpri Chinchwad Municipal Corporation Postgraduate Institute & Yashwantrao Chavan Memorial Hospital  YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018
Pune
MAHARASHTRA 
9822057511

drpravinsoni18@gmail.com 
Dr Anushka Kaustubh Waikar  Rajarshee Chhatrapati Shahu Maharaj Government Medical College,Kolhapur   Rajarshee Chhatrapati Shahu Maharaj Government Medical College and hospital, Bhausinghji Road, Dasara Chowk, Kolhapur -416002
Kolhapur
MAHARASHTRA 
7028920050

waikaranushka@gmail.com 
Dr Dhara Roy  Sardar Vallabhbhai Patel (SVP) Hospital, Department of Medicine  "Room no 1036, Medicine department 1st floor, A2 wing, SVP Hospital, Department of Medicine, Near Ellisbridge, Ahmedabad, Gujarat-380006"
Ahmadabad
GUJARAT 
7600032882

dharabhavesh@gmail.com 
Dr Chakradhararao Guduri  Sidhhartha Medical college and Govt. General Hospital  Ring road, Gundala, Vijayawada, Andhra Pradesh 520008.
Krishna
ANDHRA PRADESH 
9440231369

profguduri@gmail.com 
Dr Rakesh Bhadade  Topiwala National Medical College & Nair Hospital  Dr. A. L. Nair road, Mumbai 400008
Mumbai
MAHARASHTRA 
9820394620

rakeshbhadade@gmail.com 
Dr N Kumarasamy  VHS-Infectious Diseases Medical Centre, Chennai  SH 49A, Pallipattu, Tharamani, Chennai, Tamil Nadu 600113
Chennai
TAMIL NADU 
9176912007

kumarasamy@cartcrs.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 29  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gandhi Medical College and Hospital, Musheerabad, Secunderabad, Hyderabad, Telangana - 500003 India  Approved 
AIIMS Rsishikesh Institutional Ethics Committee  Approved 
Human Research Ethics Committee, Goverment Medical College, Surat  Approved 
Instittutional Ethics Committee BJ Medical College and General Hospital  Approved 
Institute Ethics Committee ,All India Institute of Medical Sciences, Old OT Block, New Delhi  Approved 
Institutional Ethics Committe Armed Forces Medical College,Solapur Road, Pune  Approved 
Institutional Ethics Committe PDU Medical College Rajkote Human   Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Yashwantrao Chavan Memorial Hospital, Piimpri  Approved 
Institutional Ethics Committee BVDU  Approved 
Institutional Ethics Committee Siddhartha Medical College and Goverment General Hospital Vijayawada  Approved 
Institutional Ethics Committee, Goverment Medical College, Nagpur  Approved 
Institutional Ethics Committee, Institue of Advanced Research In Health Sciences, Tamil Nadu Goverment MultiSpeciality Hospital, Omandurar Goverment Estate, Chennai  Approved 
Institutional Ethics Committee, Institue of Advanced Research In Health Sciences, Tamil Nadu Goverment MultiSpeciality Hospital, Omandurar Goverment Estate, Chennai  Approved 
Institutional Ethics Committee, PD Hinduja Hospital  Approved 
Institutional Ethics Committee, TNMC & NAIR HOSPITAL MUMBAI  Approved 
Institutional Ethics Committee,BJ Medical College and Civil Hospital, Ahemdabad, Gujrat  Approved 
Institutional Ethics Committee-AIIMS Jodhpur  Approved 
Institutional Ethics Committee-Clinical Studies Apollo Hospitals  Approved 
Institutional Ethics Committee-Clinical Studies Apollo Hospitals  Approved 
Institutional Human Ethics Committee, AIIMS BHOPAL  Approved 
Institutional Human Ethics Committee,GMERS Medical College and Hospital, Gotri Vadodara   Approved 
Kolhapur Cancer Centre Institutional Ethics Committee  Approved 
MAX HEALTHCARE ETHICS COMMITTEE  Approved 
NARI Ethics Committee  Approved 
NHL Institutional Ethics Committee  Approved 
Office of Ethics Committee SMS Medical College and Attached Hospitals Jaipur  Approved 
Office of Research Institutional Review Board, Christian Medical College, Vellore  Approved 
VHS Institutional Ethics Committee  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  chloroquine or hydroxychloroquine   local standard of care plus chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)  
Comparator Agent  Local standard of care  Local standard of care 
Intervention  Lopinavir with Ritonavir (ditto) plus Interferon   Local standard of care plus Lopinavir with Ritonavir ((orally twice daily for 14 days) plus Interferon (daily injection for 6 days). 
Intervention  Lopinavir with Ritonavir (orally twice daily for 14 days)   Local standard of Care plus Lopinavir with Ritonavir (orally twice daily for 14 days)  
Intervention  Remdesivir   local standard of care plus Remdesivir (daily infusion for 10 days)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults (aged ≥18 years) hospitalized with definite COVID-19
2. Not already receiving any of the study drugs
3. Without known allergy or contraindications to any of them (in the view of the physician responsible for their care)
4. Without anticipated transfer within 72 h to a non-study hospital

Patients invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected 
 
ExclusionCriteria 
Details  1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication)
2. Pregnant
3. Declined to participate in the study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
All-cause mortality, subdivided by the severity of disease at the time of randomization, measured using patient records throughout the study  Throughout the study 
 
Secondary Outcome  
Outcome  TimePoints 
Measured using patient records:
1. Duration of hospital stay (hours)
2. Time to first receiving ventilation (or intensive care) (hours) 
Measured using patient records:
1. Duration of hospital stay (hours)
2. Time to first receiving ventilation (or intensive care) (hours) 
 
Target Sample Size   Total Sample Size="7000"
Sample Size from India="1500" 
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 3 
Date of First Enrollment (India)   01/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/03/2020 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publication and dissemination plan This international collaboration is co-ordinated through the World Health Organization, which is also a sponsor of the trial. Any wholly reliable interim findings will be disseminated rapidly by the WHO. There will be group authorship recognizing the contribution of all national and local investigators and guided by the International Committee of Medical Journal Editors (ICMJE) recommendations. IPD sharing statement: The current data sharing plans for this study are unknown and will be available at a later date. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
There are currently no available vaccines or treatments for COVID-19. Although there have been some suggestions for untested treatments that could be added to  the usual care in hospitals, none is known to help. The World Health Organization (WHO) is, therefore, organizing a study in many countries in which some of these untested treatments are compared with each other, to discover whether any do help. The study treatments are remdesivir,  hydroxychloroquine, lopinavir plus ritonavir, and interferon-beta. Some are given as daily pills, and some as daily injections.

 
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