History
# Registration date Revision Id
3 2020-05-16, 1399/02/27 134806
2 2020-04-02, 1399/01/14 129615
1 2020-03-30, 1399/01/11 127346
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  • Protocol summary

    The effect of naproxen on the healing process of COVID-19 patients in Abadan
    The effect of naproxen on the healing process of COVID-19 patients
    بررسی تاثیر ناپروکسن در روند بهبودی بیماران مبتلا به COVID-19 در آبادان
    بررسی تاثیر ناپروکسن در روند بهبودی بیماران مبتلا به COVID-19
    This randomized clinical trial study has parallel intervention and control groups, phase 3, sample size of 40, without blinding. Samples are selected according to inclusion and exclusion criteria through convenient sampling and assigned to intervention and control groups by simple random method.
    This double-blind clinical trial study has an intervention group and a control group with parallel and randomized groups, with a sample size of 40. A phase 2 study with block randomization.
    این مطالعه کارآزمایی بالینی دارای یک گروه مداخله و یک گروه کنترل با گروه های موازی و تصادفی سازی شده ، فاز 3 با حجم نمونه 40 و بدون کورسازی می باشد. نمونه ها با توجه به معیار های ورود از طریق سرشماری انتخاب و با روش تصادفی ساده به گروه های مداخله و کنترل تخصیص می شوند.
    این مطالعه کارآزمایی بالینی دوسوکور دارای یک گروه مداخله و یک گروه کنترل با گروه های موازی و تصادفی سازی شده ، با حجم نمونه 40 می باشد. فاز این مطالعه فاز 2 و تصادفی سازی بلوکی می باشد.
    The study is being conducted at Ayatollah Taleghani Hospital in Abadan. People in the intervention group also use naproxen along with Standard protocol national drugs. But in the control group only antiviral and antibacterial drugs are used.
    The place of this study is in Ayatollah Taleghani Hospital in Abadan. In the patient control group, standard drugs use the national protocol + placebo (in terms of appearance and color similar to naproxen 500 mg every 12 hours for 5 days). In the intervention group, standard drugs of the national protocol + naproxen 500 mg every 12 hours are used for 5 days.
    این مطالعه در بیمارستان آیت الله طالقانی آبادان انجام می شود.افراد در گروه مداخله در کنار داروهای استاندارد پروتکل کشوری از ناپروکسن هم استفاده می کنند. ولی در گروه کنترل فقط داروهای استاندارد پروتکل کشوری استفاده می شود.
    محل انجام این مطالعه در بیمارستان آیت الله طالقانی آبادان می باشد. در گروه کنترل بیماران داروهای استاندارد پروتکل کشوری + دارونما (از لحاظ شکل ظاهری و رنگ شبیه ناپروکسن 500 میلی گرمی هر 12 ساعت به مدت 5 روز ) را مصرف می کنند. در گروه مداخله از داروهای استاندارد پروتکل کشوری + ناپروکسن 500 میلی گرمی هر 12 ساعت به مدت 5 روز استفاده می کنند.
    In the intervention group, patients also take naproxen in addition to taking Standard protocol national drugs. In the control group, patients only take Standard protocol national drugs.
    Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen). Intervention Group: Standard Protocol Drugs For 5 days(Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) (Indian Ritcomum) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
    در گروه مداخله بیماران در کنار مصرف داروهای استاندارد پروتکل کشوری، ناپروکسن هم استفاده می کنند. در گروه کنترل بیماران فقط داروهای استاندارد پروتکل کشوری را مصرف می کنند.
    گروه کنترل: داروهای استاندارد پروتکل کشوری ( هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) ، قرص کلترا (لوپیناویر / ریتوناویر) هر 12 ساعت 2 قرص 50/200) + دارونما هر 12 ساعت یک عدد (از لحاظ شکل ظاهری و رنگ شبیه ناپروکسن 500 میلی گرمی به مدت 5 روز گروه مداخله: داروهای استاندارد پروتکل کشوری ( هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) ، قرص کلترا (لوپیناویر / ریتوناویر) (ریتوکوم هندی ) هر 12 ساعت، 2 قرص 50/200)+ ناپروکسن 500 میلی گرمی هر 12 ساعت ( پارس دارو ) به مدت 5 روز
    The healing process of patients with COVID-19
    The recovery process of patients with Covid 19 (improvement of fever, chills, cough and night sweats)
    روند بهبودی بیماران مبتلا به Covid 19
    روند بهبودی بیماران مبتلا به Covid 19 (بهبود تب، لرز،سرفه و تعریق شبانه)
  • General information

    Not blinded
    Double blinded
    1
    1
    Not used
    Used
    empty
    Type of blinding
    empty
    نوع کورسازی
    Method of randomization is 6 unit block randomization. Unit of randomization is individual. Tools for randomization is a computer software. Sealed envelopes were used for allocation concealment
    In this study, block randomization was performed using block size: 6. Allocation sequence and concealment codes are generated by www.sealedenvelope.com. The closed envelope method was used to hide the allocation sequence.
    تصادفی سازی از نوع تصادفی سازی بلوکی که با استفاده از بلوک های 6 تایی انجام شد. زنجیره تصادفی شده با استفاده از یک نرم افزار کامپیوتری بدست آمد. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
    تصادفی سازی از نوع تصادفی سازی بلوکی که با استفاده از بلوک های 6 تایی انجام شد. زنجیره تصادفی و کد های concealment توسط وبسات www.sealedenvelope.com تولید می شود. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
    Participants and researchers in this study are blind, and the placebo used in the control group is the pill, which is similar in appearance and color to naproxen.
    شرکت کنندگان و محققین در این مطالعه کور می باشد و دارو نما ی مورد استفاده در گروه کنترل قرص می باشد که از نظر شکل ظاهری و رنگ مشابه ناپروکسن می باشند. .
  • Intervention groups

    #1
    Group 1: National standard protocol drug recipients (Hydroxychloroquine sulfate 200mg tablets two single dose (Tehran Drug) or Chloroquine phosphate 150 mg two single dose tablets (Pars), kaletra tablets (Lupinavir / ritonavir) (Indian Ritocom) 2 hour tablet 50/200)
    Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen).
    گروه مداخله: گروه 1: دریافت کننده داروهای استاندارد پروتکل کشوری (قرص هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) یا قرص کلروکین فسفات 150 mg دو قرص تک دز (پارس )، قرص کلترا (لوپیناویر / ریتوناویر) (ریتوکوم هندی ) هر 12 ساعت 2 قرص 50/200)
    گروه کنترل: داروهای استاندارد پروتکل کشوری ( هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) ، قرص کلترا (لوپیناویر / ریتوناویر) هر 12 ساعت 2 قرص 50/200) + دارونما هر 12 ساعت یک عدد (از لحاظ شکل ظاهری و رنگ شبیه ناپروکسن 500 میلی گرمی به مدت 5 روز
    #2
    Group 2: National standard protocol drug recipients (Hydroxychloroquine sulfate 200mg tablets two single dose (Tehran Drug) or Chloroquine phosphate 150 mg two single dose tablets (Pars), kaletra tablets (Lupinavir / ritonavir) (Indian Ritocom) 2 hour tablet 50/200) + naproxen 500mg Warm every 12 hours (manufactured by Pars Daroo Tehran).
    Intervention Group: Standard Protocol Drugs For 5 days (Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
    دریافت کننده داروهای استاندارد پروتکل کشوری (قرص هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) یا قرص کلروکین فسفات 150 mg دو قرص تک دز (پارس )، قرص کلترا (لوپیناویر / ریتوناویر) (ریتوکوم هندی ) هر 12 ساعت، 2 قرص 50/200)+ ناپروکسن 500 میلی گرمی هر 12 ساعت (ساخت شرکت پارس دارو تهران) .
    گروه مداخله: داروهای استاندارد پروتکل کشوری ( هیدروکسی کلروکین سولفات 200mg دو قرص تک دز ( تهران دارو) ، قرص کلترا (لوپیناویر / ریتوناویر) هر 12 ساعت، 2 قرص 50/200)+ ناپروکسن 500 میلی گرمی هر 12 ساعت ( پارس دارو ) به مدت 5 روز

Protocol summary

Study aim
The effect of naproxen on the healing process of COVID-19 patients
Design
This double-blind clinical trial study has an intervention group and a control group with parallel and randomized groups, with a sample size of 40. A phase 2 study with block randomization.
Settings and conduct
The place of this study is in Ayatollah Taleghani Hospital in Abadan. In the patient control group, standard drugs use the national protocol + placebo (in terms of appearance and color similar to naproxen 500 mg every 12 hours for 5 days). In the intervention group, standard drugs of the national protocol + naproxen 500 mg every 12 hours are used for 5 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 15 years of age, chest CT scan confirming covid-19, clinical symptoms of covid-19, confirmation of covid-19 by an infectious disease physician, having informed consent to participate in the intervention. Exclusion criteria: Has a history of gastrointestinal bleeding, pregnant or lactating women, taking losartan or captopril
Intervention groups
Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen). Intervention Group: Standard Protocol Drugs For 5 days(Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) (Indian Ritcomum) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
Main outcome variables
The recovery process of patients with Covid 19 (improvement of fever, chills, cough and night sweats)

General information

Reason for update
Type of blinding
Acronym
IRCT registration information
IRCT registration number: IRCT20200324046850N3
Registration date: 2020-03-30, 1399/01/11
Registration timing: registered_while_recruiting

Last update: 2020-04-14, 1399/01/26
Update count: 2
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Sara Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
s.mobarak@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of naproxen on the healing process of patients with COVID-19
Public title
The effect of naproxen on the healing process of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a chest CT scan to confirm Covid 19 Having Clinical symptoms of covid 19 including fever, muscle pain, shortness of breath, dry cough, sore throat, runny nose Confirmation of covid19 by an infectious disease physician Having consent to participate in the intervention
Exclusion criteria:
Pregnant and lactating women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization was performed using block size: 6. Allocation sequence and concealment codes are generated by www.sealedenvelope.com. The closed envelope method was used to hide the allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers in this study are blind, and the placebo used in the control group is the pill, which is similar in appearance and color to naproxen.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.ABADANUMS.REC.1398.115

Health conditions studied

1

Description of health condition studied
corona virus disease
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified

Primary outcomes

1

Description
fever
Timepoint
At the time of positive test and 14 days later
Method of measurement
Using oral thermometer

2

Description
Cough
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination

3

Description
Chills
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination

4

Description
Night sweats
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen).
Category
Treatment - Drugs

2

Description
Intervention Group: Standard Protocol Drugs For 5 days (Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Sara Mobarak
Street address
Ayatollah Taleghani Hospital. University Blvd. Nurse Square. Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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