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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

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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
Changes made to previous revision
This is the first revision

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
Acronym
IRCT registration information
IRCT registration number: IRCT20200318046812N1
Registration date: 2020-04-01, 1399/01/13
Registration timing: prospective

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
2020-04-02, 1399/01/14
Expected recruitment end date
2020-06-03, 1399/03/14
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 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.
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

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.
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