access to a novel and acceptable treatment.
elimination of ineffective treatments.
decreasing drug-induced complications.
comparison of effect of Atazanavir/Ritanavir and Lopinavir/Ritanavir on inflammatory biomarkers including ESR and CRP.
comparison of effect of Atazanavir/Ritanavir and Lopinavir/Ritanavir on respiratory involvement including Pneumonia and COViD-19 induced ARDS
comparison of effect of Atazanavir/Ritanavir and Lopinavir/Ritanavir on hospitalization duration.
comparison of effect of Atazanavir/Ritanavir and Lopinavir/Ritanavir on drug-induced GI complications.
comparison of effect of Atazanavir/Ritanavir and Lopinavir/Ritanavir on mortality/morbidity rate decrease.
Design
This clinical trial is a double-blinded case-control randomized study on 100 patients. Permuted block randomization technique was used for patients randomization.
Settings and conduct
This study will be performed in Bahonar hospital at the first 6 months of the year. Statistical analyses will be accomplished using STATA software.
This study is designed double-blinded (patients and physicians). Patients of each group (case or control) will be hospitalized in a specific place and do not have any contact with patients of the opposite group.
Participants/Inclusion and exclusion criteria
Patients between 20-80 years admmited to the hospital whose diseases were confirmed by CT, RT-PCR.
Intervention groups
Atazanavir/Ritonavir treatment group receives novel treatment and Lopinavir/Ritonavir treatment group receives standard treatment. adverse effects and desired effects will be assessed.
Main outcome variables
Clinic and Para clinic findings in COViD-19 patients.
Mortality and morbidity rate in COViD-19 patinets.
Duration of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200504047298N1
Registration date:2020-06-14, 1399/03/25
Registration timing:registered_while_recruiting
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Zeinab Siami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4602 2136
Email address
z.siami@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-14, 1399/03/25
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Atazanavir/Ritonavir effect on COViD-19 patients treatment in comparison with Lopinavir / Ritonavir
Public title
Effect of Atazanavir/Ritonavirin treatment of COViD-19
Patients randomized classification into standard treatment group and case group was performed using permuted block randomization. in this study, four-unit blocks were used. Using R software, a chain of randomized numbers comprising one to six are created to reach the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, researchers, and health workers were blind.
This study is designed double-blinded. Patients of each group (case or control) will be hospitalized in a specific place and do not have any contact with patients of the opposite group. Besides, a member of the research team and a doctor of infectious diseases will prescribe according to assigned treatment codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University Of Medical Sciences
Street address
Research Department, Safarian Alley, Golshahr Avenue
City
Karaj
Province
Alborz
Postal code
3198764153
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.ABZUMS.REC.1399.065
Health conditions studied
1
Description of health condition studied
COViD-19
ICD-10 code
U07.1
ICD-10 code description
Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations.
Primary outcomes
1
Description
COViD-19 patients clinical progression
Timepoint
frequently in hospitalization time
Method of measurement
need to be intubated, body temperature, heart rate, respiratory rate, cough, dyspnea, ICU admission.
Intervention group: Atazanavir/ritonavir treatment group will receive 300/100 mg of each drug for 14 days once a day. It will be prescribed as tablets.
Category
Treatment - Drugs
2
Description
Control group: Lopinavir/ritonavir treatment group will receive 200/50 mg of each drug for 14 days twice a day. It will be prescribed as tablets.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Zeinab Siami
Street address
Bahonar Hospital, Shoura Boulivard, Karaj+
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Email
siami_z@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohamad Noorisepehr
Street address
Research Office, Safarian Alley, Golshahr Avenue
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shoura Boulevard, Shahid Bahonar Hospital
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Email
z.siami@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shahid Bahonar Hospital, Shoura Boulevard, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Email
z.siami@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shahid Bahonar Hospital, Shoura Boulevard, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Email
z.siami@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
All related data except the consent form and analysis-used codes, would be accessible after final group agreement.
When the data will become available and for how long
for two years after publication
To whom data/document is available
All related data and materials would be accessible for all those who are eager for further information.
Under which criteria data/document could be used
All kinds of analyses would be allowed in case arrangement is made with corresponding author.
From where data/document is obtainable
For further documents access contact with Dr. Siami cia email address:
z.siami@abzums.ac.ir
What processes are involved for a request to access data/document
After arrangement with Dr. Siami, in case of agreement, informtaion and data would be accessible.