Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
Current status:
Approved
|
Date registered:
23/04/2020
Trial version(s)
History: 22/04/2020
History: 22/04/2020
History: 22/04/2020
History: 22/04/2020
History: 22/04/2020
Current: 22/04/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020043495
Protocol number
Solidarity-Lebanon2020
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
22/04/2020
Primary sponsor
WHO
Primary sponsor: Country of origin
Switzerland
Public title
An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
Acronym
SOLIDARITY
Scientific title
An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
Acronym
SOLIDARITY
Brief summary of the study: English
It is an international study to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti-viral agents. WHO expert groups advised that four re-purposed drugs, Remdesivir, Lopinavir (given with Ritonavir, to slow hepatic degradation), Interferon (β1a), and chloroquine or hydroxychloroquine should be evaluated in an international randomised trial. The main objective of this large international randomised trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID.
Brief summary of the study: Arabic
لا توجد حالياً لقاحات أو علاجات مرخصة لمرض كوفيد. ورغم أن بعض الأدوية المستعملة لأمراض أخرى قد تساعد قليلاً في بعض الحالات، فإنها قد لا تفيد فيها جميعا. ولذلك تجري منظمة الصحة العالمية دراسة في العديد من البلدان للمقارنة بين بعض هذه الأدوية المستخدمة واستنتاج مدى فائدتها في علاج مرض كوفيد. الادوية التي شيتم استخدامها في الدراسة هي: رمديسيفير (Remdesivir) , لابينافير (Lopinavir) و ريتونافير (Ritonavir) , إنترفيرون (Interferon), كلوروكين أوهيدروكسكلوروكين .
Health conditions/problem studied: Specify
COVID-19
Interventions: Specify
Local standard of care alone, OR local standard of care plus one of: Remdesivir Chloroquine or hydroxychloroquine Lopinavir with Ritonavir Lopinavir with Ritonavir
Key inclusion and exclusion criteria: Inclusion criteria
Eligibility: consenting adults (age ≥18) hospitalised with definite COVID-19, not already receiving any of the study drugs, without known allergy or contra-indications to any of them (in the view of the physician responsible for their care), and without anticipated transfer within 72 hours 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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion from study entry: Patients will not be randomised if, in the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated (eg, because of patient characteristics, chronic liver or heart disease, or some concurrent medication).
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Remdesivir
Type of IMP
Others
Type of IMP: Specify
anti-viral
Pharmaceutical class
ِAnti-vira Treatment; four re-purposed drugs to be used in the study some of them are already registered in Lebanon and used for other conditions
Therapeutic indication
anti-viral treatment
Therapeutic benefit
Treatment of Covid-19 hospitalized patients
Biospecimen retention
None retained
Biospecimen description
None retained for the purpose of this study
Target sample size
1000
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
27/04/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
01/04/2021
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
All data will be entered into a database created by WHO
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
Sanofi
Abbvie
Gilead
Merck
Secondary Sponsors
Name
Lebanese Ministry of Public Health
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rasha
Hamra
Beirut
Lebanon
01-830300
rashahamra@yahoo.com
MOPH
Scientific
Pierre
Abi Hana
Beirut
Lebanon
03-611221
boutrosh@hotmail.com
RHGH
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Rafic Hariri Govermental Hospital
Pierre Abi Hana
Infectious Disease
Approved
Notre Dame Des Secours
Madona Mattar
Infectious Disease
Approved
Lebanese Univeristy of Beirut Medical Center-Rizk Hospital
Roula Husni Samaha
Infectious Disease
Approved
Hotel Dieu de France
Moussa Riachi
Pulmonary
Approved
Mount Lebanon Hospital
Nadine Yared
Infectious Disease
NA
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Rafic Hariri University Hospital
09/04/2020
Iyad Issa
iyadissa71@gmail.com
01-830000
Notre Dame des Secours Centre Hospitalier Universitaire
01/04/2020
Wissam Khourt
info@chu-nds.org
09-940400
Lebanese American University- University Medical Center Rizk Hospital
22/04/2020
Joseph Stephan
irb@lau.edu.lb
09-547254, ext:2340
Hotel Dieu de France
21/04/2020
Nancy Alam
nancy.alam@usj.edu.lb
01-421000, ext:2334
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Covid-19
Coronavirus infection, unspecified (B34.2)
Covid-19
Interventions
Intervention
Description
Keyword
Standard Care
as per the hospital standards
standard care
Remdesivir
Daily infusion for 10 days
Remdesivir
Chloroquine or hydroxychloroquine
Two oral loading doses, then orally twice daily for 10 days
Chloroquine or hydroxychloroquine
Lopinavir with Ritonavir
Orally twice daily for 14 days
Lopinavir with Ritonavir
Lopinavir with Ritonavir (ditto) plus Interferon
Interferon: daily injection for 6 days
Lopinavir with Ritonavir plus Interferon
Primary Outcomes
Name
Time points
Measure
All-cause mortality, subdivided by severity of disease at the time of randomisation
At discharge or death
Discharge date or Cause of death
Key Secondary Outcomes
Name
Time points
Measure
Assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care
During Hospitalization while on treatment
Clinical improvement
Identify any serious adverse reactions
During Hospitalization while on treatment
Any serious unexpected adverse reaction that is life-threatening (e.g. anaphylaxis, Stevens-Johnson syndrome, aplastic anaemia, or anything comparably strange) must be reported within 24 hours
Virological cure
After Treatment is finalized
PCR negative twice within 48hours
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial