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CTRI Number  CTRI/2020/04/024773 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 07/02/2022
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
Modification(s)  
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 Plus 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
18066414  ISRCTN 
ISRCTN83971151  ISRCTN 
 
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
Modification(s)  
  Albania
Argentina
Bahamas
Bangladesh
Belize
Bolivia
Botswana
Brazil
Canada
Colombia
Dominica
Dominican Republic
Ecuador
Egypt
Ethiopia
Finland
Georgia
Guyana
Honduras
India
Indonesia
Iran (Islamic Republic of)
Ireland
Italy
Jamaica
Kenya
Kuwait
Latvia
Lebanon
Lithuania
Macedonia
Malaysia
Mali
Mexico
Mozambique
Niger
Nigeria
Norway
Oman
Pakistan
Panama
Paraguay
Peru
Philippines
Portugal
Romania
Saudi Arabia
Sierra Leone
Spain
Switzerland
Trinidad and Tobago
Zimbabwe  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
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 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 Rajnish Joshi  AIIMS,Bhopal  Saket nagar, Bhopal, Madhya Pradesh, 462024
Bhopal
MADHYA PRADESH 
9425303401

rajnish.genmed@aiimsbhopal.edu.in 
Dr Vikas Marwah  Army Institute of Cardio- thoracic Sciences (under AFMC)  Wanowrie, Pune - 411040
Pune
MAHARASHTRA 
9560503335

docvikasmarwah@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 
Dr E Theranirajan  Madras Medical College & Rajiv Gandhi Government General Hospital  Poonamallee High Road 3 Evr Periyar Salai Park Town Chennai Tamil Nadu 600003
Chennai
TAMIL NADU 
9003517417

gghdean@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 M Rajarao  Gandhi Medical College and Hospital  Musheerabad, Secunderabad, Hyderabad, Telangana - 500003 India
Hyderabad
TELANGANA 
9849010915

dr.mrrao@gmail.com 
Dr Jayanthi Rangarajan  Goverment Medical College, Omandurar Goverment Estate, Chennai  Goverment Medical College, Omandurar Goverment Estate, Chenna
Chennai
TAMIL NADU 
9840025339

gmcomandurar@gmail.com 
Dr Dipti Chand  Government Medical College and Hospital, Nagpur  Medical College Square road, Nagpur - 440003
Nagpur
MAHARASHTRA 
9823257601

dachand.ngp@gmail.com 
Dr Rohidas Borse  BJ Medical College and Sasson General Hospital   Near Pune Railway Station
Pune
MAHARASHTRA 
9763201215

rohidas_borse@yahoo.co.in 
Dr N Kumarasamy  VHS-Infectious Diseases Medical Centre, Chennai  SH 49A, Pallipattu, Tharamani, Chennai, Tamil Nadu 600113
Chennai
TAMIL NADU 
9176912007

kumarasamy@cartcrs.org 
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 
Dr Shubhangi Kanitkar  Dr D Y Patil Medical College Hospital & Research Center   Department Of Medicine Hospital & Research Center Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 
9422027161

shubhangi.kanitkar@dpu.edu.in 
Dr Anjan Talukdar  Gauhati Medical College and Hospital  Department of Medicine Bhangagarh PO Indrapur Guwahati Assam 781032
Kamrup
ASSAM 
9954658926

anjan110178@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gandhi Medical College and Hospital, Musheerabad, Secunderabad, Hyderabad, Telangana - 500003 India  Approved 
Ethics Committee Dr D Y Patil VidyapeethSant Tukaram Nagar Pimpri Pune  Approved 
Ethics Committee Relating to Clinical Trial All India institute of Medical Sciences Rishikesh   Approved 
Institute Ethics Committee ,All India Institute of Medical Sciences, Old OT Block, New Delhi  Approved 
Institutional Ethics Committee Armed Forces Medical College,Solapur Road, Pune  Approved 
Institutional Ethics Committee BVDU  Approved 
Institutional Ethics Committee Gauhati Medical College and Hospital Guwahati  Approved 
Institutional Ethics Committee GMC Nagpur Government Medical College and Hospital Nagpur  Approved 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT OMANDURAR MEDICAL COLLEGE 130/1, WALLAJAH ROAD NEAR KALAIVANAR ARANGAM CHENNAI Tamil Nadu 600002  Approved 
Institutional Ethics Committee Madras Medical College Chennai  Approved 
Institutional Human Ethics Committee, AIIMS BHOPAL  Approved 
NARI Ethics Committee ICMR National AIDS Research Institute Pune  Approved 
Smt.NHL Municipal Medical College Institutional Ethics committee Ahmedabad  Approved 
VHS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
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
Modification(s)  
Type  Name  Details 
Intervention  Imatinib  Imatinib, orally once daily for 14 days along with local standard of care  
Intervention  Infliximab  Infliximab, as a single IV infusion along with local standard care treatment. 
Comparator Agent  Local standard of care  Local standard of care 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults (age ≥18 years) recently hospitalised, or already in the hospital, with definite (diagnosed by RT-PCR) symptomatic COVID admitted for at least moderate or severe illness
2. In the view of the responsible doctor, no contra-indication to any of the study drugs.
3. Providing consent for the participation


 
 
ExclusionCriteria 
Details  1.Adults (age ≥18 years) with COVID and hospitalised for quarantine purposes or management of other conditions who do not have moderate or severe illness.
2.Laboratory confirmation of SARS Cov -2 infection not available
3.In the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated
Anticipated transfer to another hospital which is not a study site within 72 hours
4.Pregnant or Lactating Women
 
 
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
Modification(s)  
Total Sample Size="10000"
Sample Size from India="750" 
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
Modification(s)  
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
Modification(s)  

Now licensed vaccines are available for COVID-19 which have been shown to protect from severe disease with variying effectiveness however various strains keep emerging and there is no treatment that is 100% effective in preventing deaths. Based on available data and expert consideration, it is felt that certain drugs used to treat other diseases might be of help for COVID-19 or they might not. The first (2020) part of Solidarity was completed successfully with 26 actively recruiting sites across India and 1047 participants were randomised. The final analysis is ongoing.

Thus after evaluating 4 repurposed drugs in 2020 (Solidarity), the global trial aims to study the drugs Artesunate, Imatinib and Infliximab in comparison to Local Standard of Care in 2021(Solidarity trial Plus). The treatments chosen are aimed at suppressing specific immune responses occurring during the inflammatory phase of COVID-19.

The clinical trial protocol for these new drugs is also referred to as ‘SOLIDARITY Trial Plus’

However the Drugs Controller General of India in consultation with the subject Expert Committee while granting permission (CT-NOC No. CT-ND/89/2021)  to the trial in India has recommended removal of Artesunate arm.

In India we will test test only In Infliximab and Tab. Imatinib.

 


 
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