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Protocol summary
Evaluating efficacy and safety of Hydroxychloroquine + Oseltamivir + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
Evaluating efficacy and safety of Hydroxychloroquine + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
Evaluating efficacy and safety of Hydroxychloroquine + Oseltamivir + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین+اوسلتامیویر+لوپیناویر/ریتوناویر یا آتازاناویر/ریتوناویر در درمان بیماران با COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین + لوپیناویر/ریتوناویر یا آتازاناویر/ریتوناویر در درمان بیماران با COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین+اوسلتامیویر+لوپیناویر/ریتوناویر یا آتازاناویر/ریتوناویر در درمان بیماران با COVID-19
Patients will receive Tab hydroxychloroquine 400 mg single dose + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily + Cap oseltamivir 75 mg twice daily for at least 5 days.
Patients will receive Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.
Patients will receive Tab hydroxychloroquine 400 mg single dosetwice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily + Cap oseltamivir 75 mg twice daily for at least 5 days.
بیماران قرص هیدروکسی کلروکین 400 میلی گرم تک دوز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو قرص دوبار در روز یا قرص آتازاناویر/ریتوناویر 300/100 میلی گرم یک بار در روز + کپسول اوسلتامیویر 75 میلی گرم دوبار در روز برای حداقل 5 روز دریافت می کنند.
بیماران قرص هیدروکسی کلروکین 400 میلی گرم دوبار در روز در روز اول سپس 200 میلی گرم دو بار در روز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو قرص دوبار در روز یا قرص آتازاناویر/ریتوناویر 300/100 میلی گرم یک بار در روز برای حداقل 5 روز دریافت می کنند.
بیماران قرص هیدروکسی کلروکین 400 میلی گرم تک دوزدوبار در روز در روز اول سپس 200 میلی گرم دو بار در روز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو قرص دوبار در روز یا قرص آتازاناویر/ریتوناویر 300/100 میلی گرم یک بار در روز + کپسول اوسلتامیویر 75 میلی گرم دوبار در روز برای حداقل 5 روز دریافت می کنند.
General information
empty
Edition of the interventions due to changes in the national protocol
Edition of the interventions due to changes in the national protocol
empty
ویرایش مداخلات به علت تغییرات در پروتکل کشوری
ویرایش مداخلات به علت تغییرات در پروتکل کشوری
Evaluating efficacy and safety of Hydroxychloroquine + Oseltamivir + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
Evaluating efficacy and safety of hydroxychloroquine + lopinavir or atazanavir/ritonavir combination in patients with COVID-19
Evaluating efficacy and safety of Hydroxychloroquinehydroxychloroquine + Oseltamivir + Lopinavirlopinavir or Atazanaviratazanavir/ritonavir combination in patients with COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین+اوسلتامیویر+لوپیناویر/ریتوناویر یا آتازاناویر/ریتوناویر در درمان بیماران با COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین + لوپیناویر یا آتازاناویر/ریتوناویر در بیماران با COVID-19
بررسی اثربخشی و ایمنی ترکیب هیدروکسی کلروکین+اوسلتامیویر+لوپیناویر/ریتوناویر یا آتازاناویر/ریتوناویر در درمان بیماران با COVID-19
Intervention groups
#1
Intervention group: Patients in this group will receive triple-drug regimen including hydroxychloroquine 200 mg two tablets singe dose + cap oseltamivir 75 mg twice daily + lopinavir/ritonavir 200/50 mg two tablets twice daily or atazanavir/ritonavir 300/100 mg daily for at least 5 days.
Intervention group: Patients in this group will receive drug regimen including Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.
Intervention group: Patients in this group will receive triple-drug regimen including Tab hydroxychloroquine 200400 mg two tablets singe dose + cap oseltamivir 75twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.
گروه مداخله: بیماران مورد بررسی رژیم سه دارویی شامل دو عدد قرص هیدروکسی کلروکین 200 میلی گرم تک دوز + کپسول اوسلتامیویر 75 میلی گرم دو بار در روز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو عدد دو بار در روز یا آتازاناویر/ریتوناویر 300/100 میلی گرم یک عدد روزانه را برای حداقل 5 روز دریافت می کنند.
گروه مداخله: بیماران مورد بررسی رژیم دارویی شامل قرص هیدروکسی کلروکین 400 میلی گرم دوبار در روز در روز اول سپس 200 میلی گرم دو بار در روز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو قرص دو بار در روز یا قرص آتازاناویر/ریتوناویر 300/100 میلی گرم روزانه برای حداقل 5 روز دریافت می کنند.
گروه مداخله: بیماران مورد بررسی رژیم سه دارویی شامل دو عدد قرص هیدروکسی کلروکین 200400 میلی گرم تک دوز + کپسول اوسلتامیویر 75دوبار در روز در روز اول سپس 200 میلی گرم دو بار در روز + قرص لوپیناویر/ریتوناویر 200/50 میلی گرم دو عددقرص دو بار در روز یا قرص آتازاناویر/ریتوناویر 300/100 میلی گرم یک عدد روزانه را برای حداقل 5 روز دریافت می کنند.
Protocol summary
Study aim
Evaluating efficacy and safety of Hydroxychloroquine + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
Design
This is a non-blinded, single group clinical trial.
Settings and conduct
Following data will be collected from admitted patients to Imam Khomeini hospital complex (according to the type of data at admission, daily or every other day)
Chief complaint at admission
Vital singes
Baseline diseases
History of drug use
History of vaccination
Hemodynamic parameters
Oxygenation parameters
Laboratory data
Respiratory support requirement
Supportive care
Drug therapy
Adverse drug reactions
Duration of hospitalization
Complications during hospitalization
Clinical outcome
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with highly suspected or confirmed COVID-19 who are candidate for hospitalization and starting triple-drug therapy
Exclusion criteria: History of drug allergy, pregnancy and lactation
Intervention groups
Patients will receive Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.
Main outcome variables
Clinical response
Laboratory response
Incidence rate of adverse drug reactions
General information
Reason for update
Edition of the interventions due to changes in the national protocol
Acronym
IRCT registration information
IRCT registration number:IRCT20100228003449N30
Registration date:2020-03-22, 1399/01/03
Registration timing:registered_while_recruiting
Last update:2020-03-24, 1399/01/05
Update count:1
Registration date
2020-03-22, 1399/01/03
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating efficacy and safety of hydroxychloroquine + lopinavir or atazanavir/ritonavir combination in patients with COVID-19
Public title
Combination therapy in COVID 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with highly suspected or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination
Exclusion criteria:
History of drug allergy
Pregnancy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University Of Medical Sciences
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1058
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical response
Timepoint
Every other day
Method of measurement
Evaluation of clinical signs and symptoms
2
Description
Paraclinical response
Timepoint
Every other day
Method of measurement
Laboratory and radiological findings
3
Description
Adverse drug reactions
Timepoint
Every other day
Method of measurement
Interview and laboratory data
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
End of hospitalization
Method of measurement
Medical records
2
Description
Clinical outcome
Timepoint
End of study
Method of measurement
Patient's record
Intervention groups
1
Description
Intervention group: Patients in this group will receive drug regimen including Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Boulveard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6695 4515
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and metaanalysis
From where data/document is obtainable
For this you may ask Hossein Khalili through following information: Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks
Comments
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks