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Safety and efficacy of “Hydroxychloroquine + Azithromycin + Naproxen + Prednisolone” and “Hydroxychloroquine + Azithromycin + Naproxen” regimens in comparison with “Hydroxychloroquine + kaletra” on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study

Protocol summary

Study aim
Achieve an appropriate treatment protocol for COVID-19
Design
Randomized parallel, 3groups, clinical trial, open label
Settings and conduct
It is a multicenter clinical trial that will be conducted in at least 4 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 RTPCR 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 (Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir); Uncontrolled diabetes; Asthma; Chemotherapy in the past month; Taking immunosuppressive drugs; Chronic liver or renal failure; HIV; GI bleeding; Pregnancy; Lactation; Uncontrolled bacterial infection
Intervention groups
Intervention group1: Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by two 250 mg Azythromycin in first day and 250 mg Azythromycin a day for 5 days +five 5 mg Prednisolone tablets a day for 5 days +250 mg Naproxen tablets two times a day for 5 days. Intervention group2: Stat dose of two 200 mg Hydroxychloroquine tablets followed by two 250 mg Azythromycin in first day and 250 mg Azythromycin a day for 5 days plus 250 mg Naproxen tablets two times a day for 5 days. Control group: Stat dose of two 200 mg Hydroxychloroquine tablets followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days.
Main outcome variables
Admission to ICU, 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), Pulmonary function test 6 wks after discharge, and Adverse and allergic drug reactions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200318046812N2
Registration date: 2020-04-08, 1399/01/20
Registration timing: prospective

Last update: 2020-04-08, 1399/01/20
Update count: 0
Registration date
2020-04-08, 1399/01/20
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
2020-04-10, 1399/01/22
Expected recruitment end date
2021-04-11, 1400/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of “Hydroxychloroquine + Azithromycin + Naproxen + Prednisolone” and “Hydroxychloroquine + Azithromycin + Naproxen” regimens in comparison with “Hydroxychloroquine + kaletra” on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
Public title
evaluation of Safety and efficacy of anti inflammatory regimens 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 RTPCR test for COVID-19 Requiring hospitalization Patient's age between 16 and 100 years Signed informed consent form
Exclusion criteria:
Past history of hospitalization or treatment in hospital for COVID-19 disease Receiving other antiviral medications such as (Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir) Uncontrolled diabetes Astma Chemotherapy in the past month Taking immunosuppressive drugs Chronic liver or renal failure Taking daily systemic corticosteroids HIV GI bleeding Pregnancy or Lactation Uncontrolled bacterial infection
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: 906
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
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.1399.019

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1 COVI
ICD-10 code description
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
Discharge without Intensive care need
Timepoint
Once
Method of measurement
Patient medical records

10

Description
Pulmonary function
Timepoint
6 weeks after discharge
Method of measurement
Spirometry and a six-minute walking test are performed. Pulmonary function status is divided into two groups, normal and abnormal

11

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

12

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

Intervention groups

1

Description
Intervention group: Intervention group: Group 1: Patients in this group will first receive hydroxychloroquine as two 200 mg tablets with a total of 400 mg of stat; then the following regimen will be continued for 5 days - azithromycin two 250 mg tablets on the first day. And then 250 mg daily for 5 days - 5 mg prednisolone tablets in the amount of 5 tablets (25 mg) daily for 5 days - 250 mg naproxen tablets twice a day for 5 days. Also, patients in this group to prevent complications. Digestive patients will receive 40 mg of pentoprazole tablets or capsules daily during treatment. According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary. The patient will be discharged from the protocol. In this case, all the patient's information will be collected until the end of the study. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Prednisolone in this group will continue to be cleared and gradually reduced to 5 mg each week to be discontinued. The weekly dose will be as follows: -First week after clearance: 20 mg per day -Second week after clearance: 15 mg per day- Third week after clearance: 10 mg per day -Fourth week after clearance 5 Mg per day and finally discontinued
Category
Treatment - Drugs

2

Description
Intervention group: Patients in this group will first receive hydroxychloroquine in the form of two 200 mg tablets with a total of 400 mg of stat; then the following diet will be continued for 5 days.- Azithromycin two 250 mg tablets on the first day and then 250 mg daily for 5 days- Naproxen tablets 250 mg twice daily for 5 daysIn addition, patients in this group will receive 40 mg tablets or pentoprazole capsules daily to prevent gastrointestinal side effects during treatment.According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary.In this group, starting antiviral or steroid therapy before the need for treatment in the intensive care unit will cause the patient to leave the protocol. In this case, all patient information will continue to be collected until the end of the study.If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician.
Category
Treatment - Drugs

3

Description
Control group: Patients in this group first receive two 200 mg hydroxychloroquine stats and then receive the following diet for 7 to 10 days:- kaltra (Lupinavir / Ritonavir) twice a day and two tablets of 200/50 mg each time for 7 days.Acetaminophen and oxycodone will be used if you need painkillers and antipyretics.According to the attending physician, this treatment protocol can be continued for 14 days, depending on the clinical symptoms, if necessary.In this group, the use of steroidal and non-steroidal anti-inflammatory drugs is not allowed until the need for treatment in the intensive care unit. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah university of medical sciences
Full name of responsible person
ََAli Qazvini
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0067
Email
qazvinia@gmail.com

2

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
a.h.ghazale@gmail.com

3

Recruitment center
Name of recruitment center
Forghani Hospital
Full name of responsible person
Dr Abolfazl Mozafari
Street address
Nekoei Square
City
Ghoum
Province
Ghoum
Postal code
02537211069
Phone
+98 25 3721 1061
Email
a.h.ghazele@gmail.com

4

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr Mahtab Niroomand
Street address
Tajrish squre
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mahtabniroomand@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
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
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
Academic

2

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Hassan Saadat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0067
Email
saadat350@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Qazvini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
pulmonologist
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0067
Email
qazvinia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amir Hossein Ghazale
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0067
Email
a.h.ghazale@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
From where data/document is obtainable Researchers can request data by emailing Dr. Mustafa Qanei (mghaneister@gmail.com) or Dr.Ali Qazvini(qazvinia@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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