History
# Registration date Revision Id
7 2020-09-19, 1399/06/29 151453
6 2020-08-23, 1399/06/02 148658
5 2020-08-04, 1399/05/14 145977
4 2020-05-31, 1399/03/11 136835
3 2020-04-12, 1399/01/24 129239
2 2020-04-01, 1399/01/13 127629
1 2020-04-01, 1399/01/13 127585
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  • General information

    2020-04-02, 1399/01/14
    2020-04-01, 1399/01/13
    2020-06-03, 1399/03/14
    2020-06-02, 1399/03/13
    empty
    Actual trial started one day earlier and more centers added
    empty
    تاریخ شروع کارآزمایی یک روز زودتر آغاز می شود و تعداد مراکز نیز اضافه شدند
    In this study, we will use block randomization methods using block size of four. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team.
    In this study, we will use block randomization methods using variable block size of four and six stratified by center. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team.
    در این مطالعه از روش تصادفی سازی بلوکی ( Block Randomization ) با استفاده از بلوک های چهار تایی با ترتیب تصادفی استفاده خواهد شد. از نرم افزار اکسل و فانکشن rand برای تهیه ترتیب های تصادفی بهره خواهیم گرفت. فایل های ایجاد شده در طی پروسه تولید زنجیره تصادفی و نتایج آن نزد اپیدمیولوژیست مطالعه نگهداری خواهد شد.
    در این مطالعه از روش تصادفی سازی بلوکی ( Block Randomization ) با استفاده از بلوک های چهار تایی، و شش تایی با ترتیب تصادفی طبقه بندی شده با مرکز استفاده خواهد شد. از نرم افزار اکسل و فانکشن rand برای تهیه ترتیب های تصادفی بهره خواهیم گرفت. فایل های ایجاد شده در طی پروسه تولید زنجیره تصادفی و نتایج آن نزد اپیدمیولوژیست مطالعه نگهداری خواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Isfahan Khorshid Hospital
    Name of recruitment center - Persian: بیمارستان خورشید اصفهان
    Full name of responsible person - English: Dr Ramin Sami
    Full name of responsible person - Persian: دکتر رامین سامی
    Street address - English: 8 Behehst St, Ostandari St
    Street address - Persian: هشت بهشت، خ استانداری
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 03132222127
    Phone: +98 31 3222 2127
    Fax:
    Email: biganeh75@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Shahid Beheshti
    Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
    Full name of responsible person - English: Dr Mansooreh Momen Heravi
    Full name of responsible person - Persian: دکتر منصوره مومن هروی
    Street address - English: Qotb ravandi Bulevard
    Street address - Persian: بلوار قطب راوندی
    City - English: Isfahan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715981151
    Phone: +98 31 5554 0026
    Fax:
    Email: biganeh75@gmail.com
    Web page address:
    #3
    Name of recruitment center - English: Kosar Hospital
    Name of recruitment center - Persian: بیمارستان کوثر سمنان
    Full name of responsible person - English: Dr Mohamad Memarian
    Full name of responsible person - Persian: دکتر محمد معماریان
    Street address - English: Golestan town
    Street address - Persian: شهرک گلستان
    City - English: Semnan
    City - Persian: سمنان
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3519899951
    Phone: +98 23 3142 0023
    Fax:
    Email: biganeh75@gmail.com
    Web page address:
    #4
    Name of recruitment center - English: Velaiat Hospital
    Name of recruitment center - Persian: بیمارستان ولایت قزوین
    Full name of responsible person - English: Dr Mariam Qaraati
    Full name of responsible person - Persian: دکتر مریم قرائتی
    Street address - English: Taavon Square
    Street address - Persian: میدان تعاون
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 02833790610
    Phone: +98 28 3379 0627
    Fax:
    Email: biganeh75@gmail.com
    Web page address:
    #5
    Name of recruitment center - English: Emam khomeini Hospital
    Name of recruitment center - Persian: بیمارستان امام ساری
    Full name of responsible person - English: Dr Roya Qasemian
    Full name of responsible person - Persian: دکتر رویا قاسمیان
    Street address - English: Imam Square, Vali Asr Highway
    Street address - Persian: میدان امام، بزرگراه ولی عصر
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 01133361700
    Phone: +98 11 3336 1700
    Fax:
    Email: biganeh75@gmail.com
    Web page address:
    #6
    Name of recruitment center - English: Labafinejad Hospital
    Name of recruitment center - Persian: بیمارستان لبافی نژاد تهران
    Full name of responsible person - English: Dr Shadi Ziaei
    Full name of responsible person - Persian: دکتر شادی ضیایی
    Street address - English: Pasdaran St, 9th Bostan St
    Street address - Persian: خیابان پاسداران - خیابان بوستان نهم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1666663111
    Phone: +98 21 2360 1000
    Fax:
    Email: biganeh75@gmail.com
    Web page address:

Protocol summary

Study aim
Comparing safety and efficacy of Favipiravir and Kaletra in COVID-19
Design
Randomized parallel group, clinical trial, open label
Settings and conduct
The design is a multicenter clinical trial that will be conducted in 10 centers all over the country.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19; Requiring hospitalization; Patient's age between 16 and 100 years; Signed informed consent form; Exclusion criteria: Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir); Chronic liver or renal failure; HIV; GI bleeding; Pregnancy; Lactation; QT interval > 500 ms.
Intervention groups
Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) followed by Favipiravir 600 mg three times a day for 7 days plus Hydroxychloroquine 200mg two times per day for 7 days. Control group: Group receiving Kaletra plus Hydroxychloroquine regimen. Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days.
Main outcome variables
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) Fever, Dyspnea, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions

General information

Reason for update
Actual trial started one day earlier and more centers added
Acronym
IRCT registration information
IRCT registration number: IRCT20200318046812N1
Registration date: 2020-04-01, 1399/01/13
Registration timing: registered_while_recruiting

Last update: 2020-04-01, 1399/01/13
Update count: 6
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Mostafa Ghanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0067
Email address
mghaneister@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-06-02, 1399/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
Public title
Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19 Requiring hospitalization because of: Patient's oxygen saturation less than 93% OR Requiring hospitalization because of: GCS score less than 15 OR Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal) Patient's age between 16 and 100 years Signed informed consent form.
Exclusion criteria:
Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...) Chronic liver failure Chronic Renal Failure Patients with acute problems whose survival is expected to be less than 48 hours HIV patients A history of gastrointestinal bleeding Pregnancy and lactation QT interval exceeds 500 ms
Age
From 16 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 324
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use block randomization methods using variable block size of four and six stratified by center. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team.
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
Iran university of medical sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.IUMS.REC.1399.065

2

Ethics committee
Name of ethics committee
Baqiyatallah university of medical sciences
Street address
Tehran, Vanak Square, Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-03-26, 1399/01/07
Ethics committee reference number
IR.BMSU.REC.1399.017

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
COVID-19
ICD-10 code description
U07.1 COVID-19

Primary outcomes

1

Description
Admission to intensive care unit
Timepoint
Once (when admitted to intensive care unit)
Method of measurement
Hospital records

Secondary outcomes

1

Description
In-hopital mortality
Timepoint
once
Method of measurement
Patient medical records

2

Description
length of stay in hospital
Timepoint
Once at discharge
Method of measurement
Patient medical records

3

Description
Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area
Timepoint
CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one
Method of measurement
Patient CT scan

4

Description
Laboratory Treatment Response; return of blood cell count and CRP values to normal
Timepoint
Daily
Method of measurement
Laboratory kits

5

Description
Fever
Timepoint
Daily
Method of measurement
Patient medical records

6

Description
Dyspnea
Timepoint
Daily
Method of measurement
Patient medical records

7

Description
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Timepoint
4 times a day while in the wards
Method of measurement
Observation

8

Description
Oxygen therapy maximum flow during the day (lit/min)
Timepoint
Daily
Method of measurement
Patient medical records

9

Description
Allergic drug reaction
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms

10

Description
Adverse drug reactions
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms

Intervention groups

1

Description
Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) followed by Favipiravir 600 mg three times a day for 7 days plus Hydroxychloroquine 200mg two times per day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.
Category
Treatment - Drugs

2

Description
Control group: Group receiving Kaletra plus Hydroxychloroquine regimen. Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah university of medical sciences
Full name of responsible person
Dr Behzad Einollahi
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0067
Email
einollahi@numonthly.com
Web page address

2

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr Hossein Khalili
Street address
Tehran, Keshavarz Bulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8860 0067
Email
biganeh75@gmail.com

3

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr Farhad Zamani
Street address
Valiasr Square, Karimkhan Bulevard., Behafarin st.,
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1809
Email
biganeh75@gmail.com

4

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr Farzaneh Dastan
Street address
Niavaran, Bahonar St., DarAbad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
biganeh75@gmail.com

5

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Saeid Kalantari
Street address
Satarkhan, Niayesh St., Maziar Mansouri St.,
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
biganeh75@gmail.com

6

Recruitment center
Name of recruitment center
Isfahan Khorshid Hospital
Full name of responsible person
Dr Ramin Sami
Street address
8 Behehst St, Ostandari St
City
Isfahan
Province
Isfehan
Postal code
03132222127
Phone
+98 31 3222 2127
Email
biganeh75@gmail.com

7

Recruitment center
Name of recruitment center
Shahid Beheshti
Full name of responsible person
Dr Mansooreh Momen Heravi
Street address
Qotb ravandi Bulevard
City
Isfahan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
biganeh75@gmail.com

8

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Dr Mohamad Memarian
Street address
Golestan town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 0023
Email
biganeh75@gmail.com

9

Recruitment center
Name of recruitment center
Velaiat Hospital
Full name of responsible person
Dr Mariam Qaraati
Street address
Taavon Square
City
Qazvin
Province
Qazvin
Postal code
02833790610
Phone
+98 28 3379 0627
Email
biganeh75@gmail.com

10

Recruitment center
Name of recruitment center
Emam khomeini Hospital
Full name of responsible person
Dr Roya Qasemian
Street address
Imam Square, Vali Asr Highway
City
Sari
Province
Mazandaran
Postal code
01133361700
Phone
+98 11 3336 1700
Email
biganeh75@gmail.com

11

Recruitment center
Name of recruitment center
Labafinejad Hospital
Full name of responsible person
Dr Shadi Ziaei
Street address
Pasdaran St, 9th Bostan St
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 1000
Email
biganeh75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Mostafa Ghanei
Street address
Tehran, Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0067
Email
mghaneister@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Biganeh
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 31 5472 3386
Email
Biganeh75@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Mostafa Ghanee
Position
Faculty member Baqiyatallah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
pulmonologist
Street address
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0067
Email
mghaneister@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Biganeh
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 31 5472 3386
Email
Biganeh75@gmail.com

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified IPD related to outcome will be shared.
When the data will become available and for how long
The access period will begin 6 months after publication of the paper
To whom data/document is available
The data will be available only for academic researchers.
Under which criteria data/document could be used
Only meta-analysis in collaboration with the current study research team will be permitted.
From where data/document is obtainable
Researchers can request data by emailing Dr. Mustafa Qanei (mghaneister@gmail.com) or Dr. Mehdi Bagheri (mbagheri.pharm@gmail.com).
What processes are involved for a request to access data/document
Requested data will be sent by email after consideration and approval by the relevant authorities from Baghiattallah university.
Comments
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