| CTRI Number |
CTRI/2020/04/024773 [Registered on: 21/04/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| 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)
|
|
|
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)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
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.
|