Randomzied trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care- Iranian SOLIDARITY multicentre trial
Main Aim:
To evaluate the safety and efficacy of medications in treating COVID-19
Specific Aims:
-To evaluate the safety and efficacy of Remdesivir in treating COVID-19
-To evaluate the safety and efficacy of Chloroquine/Hydroxychloroquine in treating COVID-19
-To evaluate the safety and efficacy of Lopinovir/Retinovir in treating COVID-19
-To evaluate the safety and efficacy of Lopinovir/Retinovir along with Interferon in treating COVID-19
-To compare the efficacy of medications in treating COVID-19
This trial will be performed in 30 hospitals throughout Iran. Clinicians will randomize patients using the study website and provide the appropriate treatment per protocol.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
-Adults (age ≥18)
-Hospitalised with definite COVID-19 diagnosis, not already receiving any of the study medications
-No known allergy or contraindications to any of the study medications
-Patients admitted to collaborating hospitals, without anticipated transfer within 72 hours
Exclusion Criteria:
-Anyone having a significant contraindication to any one of the study drugs
-Serious chronic liver or heart disease
-Pregnancy
Intervention groups
• Local standard of care alone
OR local standard of care plus one of:
• Remdesivir (daily infusion for 10 days)
• Chloroquine or Hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days) [NB Some collaborating hospitals will study chloroquine, others hydroxychloroquine]
• Lopinavir with Ritonavir (orally twice daily for 14 days)
• Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days).
Main outcome variables
Main Outcome: All-cause mortality
Major Secondary Outcomes:
-Duration of hospitalization
-Time to ventilation (ICU Care)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200405046953N1
Registration date:2020-04-06, 1399/01/18
Registration timing:prospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Hossein Poustchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5204
Email address
h.poustchi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomzied trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care- Iranian SOLIDARITY multicentre trial
Public title
Comparison of therapies for COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (age ≥18)
Hospitalised with definite COVID-19 diagnosis, not already receiving any of the study medications
No known allergy or contraindications to any of the study medications
Patients admitted to collaborating hospitals, without anticipated transfer within 72 hours
Exclusion criteria:
Anyone having a significant contraindication to any one of the study drugs
Serious chronic liver or heat disease
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
3000
Randomization (investigator's opinion)
Randomized
Randomization description
Given that this study is part of the SOLIDARITY Trial by the World Health Organization, the randomization method is only known by the Principal Investigators.
Patients will be randomized through the study website equally between all the locally available treatment regimens (5 possibilities if all study drugs are locally available, fewer if not)
• Local standard of care alone,
OR local standard of care plus one of
• Remdesivir (daily infusion for 10 days)
• Chloroquine or Hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)
[NB Some collaborating hospitals will study chloroquine, others hydroxychloroquine]
• Lopinavir with Ritonavir (orally twice daily for 14 days)
• Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development (NIMAD)
Street address
No. 21, Be'sat Alley, East Fatemi St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2020-04-02, 1399/01/14
Ethics committee reference number
IR.NREC.1399.001
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Primary Outcome: All-cause mortality
Timepoint
Any time death or discharge of patients occurs
Method of measurement
Death certificate signed by hospital clinicians or discharge documents
Secondary outcomes
1
Description
Duration of Hospital Stay
Timepoint
Any time during the study
Method of measurement
Based on Medical Charts
2
Description
Time to ventilation (ICU Care)
Timepoint
Any time during the study
Method of measurement
Based on Medical Chart
Intervention groups
1
Description
Intervention group: local standard of care plus Remdesivir (daily infusion for 10 days)
Category
Treatment - Drugs
2
Description
Intervention group: local standard of care plus Chloroquine or Hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)
Category
Treatment - Drugs
3
Description
Intervention group: local standard of care plus Lopinavir with Ritonavir (orally twice daily for 14 days)
Category
Treatment - Drugs
4
Description
Intervention group: local standard of care plus Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days).
Category
Treatment - Drugs
5
Description
Control group: local standard of care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Hadiseh Hosami
Street address
Behdari St.
City
Tehran
Province
Tehran
Postal code
1111111111
Email
h-hosami@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohammad Reza Salehi
Street address
Keshavarz Blvd. Dr. Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733141
Email
salehi.mohamad3@gmail.com
3
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Ilad Alavi Darazam
Street address
Karegare Jonoobi Ave, Lashgar , Makhsoos St.
City
Tehran
Province
Tehran
Postal code
1333635445
Email
Ilad13@yahoo.com
4
Recruitment center
Name of recruitment center
FIroozgar Hospital
Full name of responsible person
Mitra Ranjbar
Street address
Valiasr Sq. Karimkhan St. Beh Afarin St.
City
Tehran
Province
Tehran
Postal code
1593747811
Email
mitraranjbar@yahoo.com
5
Recruitment center
Name of recruitment center
Masih Danesvari Hospital
Full name of responsible person
Payam Tabarsi
Street address
Shahid Bahonar St. Darabad St.
City
Tehran
Province
Tehran
Postal code
1956944413
Email
payamtabarsi@yahoo.com
6
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Alireza Soleimani
Street address
Resalat Intersection
City
Karaj
Province
Alborz
Postal code
3154686695
Email
ali.doctor@yahoo.com
7
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahnaz Amini
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Email
aminim@mums.ac.ir
8
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Saeid Hafizi Lotfabadi
Street address
Vakil Abad Ave. Imam Reza Alley
City
Mashhad
Province
Razavi Khorasan
Postal code
9351899983
Email
Saeedha917@gmail.com
9
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Mohsen Moghadami
Street address
Meshkin Fam St.
City
Shiraz
Province
Fars
Postal code
7143918796
Email
moghadami@sums.ac.ir
10
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Mohsen Moghadami
Street address
Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194815644
Email
moghadami@sums.ac.ir
11
Recruitment center
Name of recruitment center
Shahid Beheshti
Full name of responsible person
Ahmad Hormati
Street address
Shahid Beheshti Sq. Azadegan Blvd.
City
Qom
Province
Ghoum
Postal code
1111111111
Email
hormatia@yahoo.com
12
Recruitment center
Name of recruitment center
Kamkar Hospital
Full name of responsible person
Mohammad Reza Ghadir
Street address
Dey 19th St.
City
Qom
Province
Ghoum
Postal code
1111111111
Email
Ghadir1968@gmail.com
13
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Alireza Musavi
Street address
Shahid Ghandi Blvd. Ebn Sina St.
City
Yazd
Province
Yazd
Postal code
8915887857
Email
musavialireza104@gmail.com
14
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Khalil Ansarin
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Email
dr.ansarin@gmail.com
15
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farzin Khorvash
Street address
Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Email
Farzin300@gmail.com
16
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Kiana Shirani
Street address
Ostandari St.
City
Isfahan
Province
Isfehan
Postal code
1111111111
Email
Shirani.kiana@gmail.com
17
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Atousa Hakami Fard
Street address
Ebne Sina St.
City
Isfahan
Province
Isfehan
Postal code
1111111111
Email
atousahakamifard@yahoo.com
18
Recruitment center
Name of recruitment center
Esabne Maryam Hospital
Full name of responsible person
Mehrdad Salahi
Street address
Shams Abadi St.
City
Isfahan
Province
Isfehan
Postal code
1111111111
Email
salahimehrdad@yahoo.com
19
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Fariborz Mansour Ghanaie
Street address
Sardare Jangal St.
City
Rasht
Province
Guilan
Postal code
41448
Email
ghanaie@yahoo.com
20
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Farhang Baba Mahmoodi
Street address
Yusef Reza St.
City
Ghaem Shahr
Province
Mazandaran
Postal code
1111111111
Email
Farhang.baba@yahoo.com
21
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Roya Ghasemian
Street address
Imam St. Amir Mazandarani St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Email
Roya31gh@yahoo.com
22
Recruitment center
Name of recruitment center
Shayyad Shirazi Hospital
Full name of responsible person
Behnaz Khodabakhshi
Street address
Shahid Sayad Shirazi Blvd.
City
Gorgan
Province
Golestan
Postal code
1111111111
Email
Behkhoda@yahoo.com
23
Recruitment center
Name of recruitment center
Baghiyatallah Hospital
Full name of responsible person
Mostafa Ghanei
Street address
Vanak Sq. Molasadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Email
mghaneister@gmail.com
24
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Hossein Sarmadian
Street address
Daneshgah St.
City
Arak
Province
Markazi
Postal code
1111111111
Email
Hosseinsarmadian2015@yahoo.com
25
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Behnam Mahmoodieh
Street address
Hazrate Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957558
Email
behnammahmoodiyeh@gmail.com
26
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Mostafa Javanian
Street address
Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Email
mjavanian@gmail.com
27
Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Mostafa Javanian
Street address
Modaras St. Mostafa Khomeini St.
City
Babol
Province
Mazandaran
Postal code
1111111111
Email
mjavanian@gmail.com
28
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Hassan Mozaffar
Street address
Motahari St. Modares Blvd.
City
Saveh
Province
Markazi
Postal code
1111111111
Email
Hassan.mozaffar@gmail.com
29
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Mehdi Mesri
Street address
Tehran Old Route, Golha Route
City
Saveh
Province
Markazi
Postal code
1111111111
Email
Mesrimd@gmail.com
30
Recruitment center
Name of recruitment center
Boo Ali Sina Hospital
Full name of responsible person
HamidReza Najjari
Street address
BooAli St.
City
Qazvin
Province
Qazvin
Postal code
1111111111
Email
Mrpthndr1382@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Ministry of Health and Medical Education, Deputy of Research and Technology
Full name of responsible person
Reza Malekzadeh
Street address
Shahrake Gharb, Falamak St.
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8241 5000
Email
dr.reza.malekzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Ministry of Health and Medical Education, Deputy of Research and Technology
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Poustchi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Karegare Shomali St. Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5204
Email
h.poustchi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Minoo Mohraz
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Keshavarz Blvd. Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
982161190
Email
minoomohraz@ams.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Poustchi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Karegare Shomali St. Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5204
Email
h.poustchi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data collected in this study belongs to the World Health Organization SOLIDARITY Trial.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol and the informed consent use will be shared after the completion of the study, if requested.
When the data will become available and for how long
Not Applicable
To whom data/document is available
The documents will be made available to any interested researcher, affiliated with a university/institution wanting to use them.
Under which criteria data/document could be used
There are no specific criteria for use.
From where data/document is obtainable
Documents can be obtained from the central committee of the SOLIDARITY Trial in Iran--Dr. Hossein Poustchi or Dr. Minoo Mohraz.
What processes are involved for a request to access data/document
Formal request from the researcher interested, in their affiliated university's letterhead sent to Dr. Hossein Poustchi.