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Protocol summary
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.
This double-blind clinical trial study has an intervention group and a control group with parallel and randomized groups, with a sample size of 80. A phase 2 study with block randomization.
This double-blind clinical trial study has an intervention group and a control group with parallel and randomized groups, with a sample size of 4080. A phase 2 study with block randomization.
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.
این مطالعه کارآزمایی بالینی دوسوکور دارای یک گروه مداخله و یک گروه کنترل با گروه های موازی و تصادفی سازی شده ، با حجم نمونه 80 می باشد. فاز این مطالعه فاز 2 و تصادفی سازی بلوکی می باشد.
این مطالعه کارآزمایی بالینی دوسوکور دارای یک گروه مداخله و یک گروه کنترل با گروه های موازی و تصادفی سازی شده ، با حجم نمونه 4080 می باشد. فاز این مطالعه فاز 2 و تصادفی سازی بلوکی می باشد.
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
Inclusion criteria: COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Exclusion criteria: pregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years
Inclusion criteria: Over 15 yearsCOVID-19 patients that have positive PCR test of age, chestnasopharyngeal sample or have positive CT scan confirming covid-19, clinical symptoms of covid-19, confirmation of covid-19 by an infectious disease physician, having informedScan Having consent to participate in the intervention. Exclusion criteria: Haspregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding, pregnant or lactating women, taking losartan or captopril. Children under 14 years
شرایط ورود: داشتن سن بالای 15 سال .داشتن سی تی اسکن از قفسه سینه که ابتلا به covid19 را تایید کند.داشتن علایم بالینی ابتلا به covid19. تایید ابتلا به covid19 توسط پزشک متخصص عفونی. داشتن رضایت آگاهانه از شرکت در مداخله. شرایط عدم ورود: داشتن سابقه خونریزی های گوارشی.زنان باردار یا شیر ده. سابقه مصرف لوزارتان یا کپتوپریل
شرایط ورود: بیماران مبتلا به covid-19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت دارند ، داشتن رضایت به شرکت در مداخله
شرایط عدم ورود: زنان باردار و شیرده کسانی که لوزاراتان و کپتوپریل مصرف می کنند، کسانی که سابقه زخم روده یا خونریزی گوارشی دارند، بچه های زیر 14 سال
شرایط ورود: داشتن سن بالای 15 سال .داشتن سی تی اسکن از قفسه سینهبیماران مبتلا به covid-19 که ابتلابیماری آنها به covid19 را تایید کند.داشتن علایم بالینی ابتلا به covid19. تایید ابتلا به covid19 توسط پزشک متخصص عفونی.وسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت دارند ، داشتن رضایت آگاهانه ازبه شرکت در مداخله. شرایط عدم ورود: داشتنزنان باردار و شیرده کسانی که لوزاراتان و کپتوپریل مصرف می کنند، کسانی که سابقه زخم روده یا خونریزی گوارشی دارند، بچه های گوارشی.زنان باردار یا شیر ده. سابقه مصرف لوزارتان یا کپتوپریلزیر 14 سال
General information
40
80
4080
2020-03-28, 1399/01/09
2020-04-20, 1399/02/01
2020-0304-2820 00:00:00
2020-04-20, 1399/02/01
2020-05-20, 1399/02/31
2020-0405-20 00:00:00
Type of blinding
Edit publication list and date of recruitment
TypeEdit publication list and date of blindingrecruitment
نوع کورسازی
ویرایش لیست انتشار و تاریخ بیمارگیری
نوع کورسازیویرایش لیست انتشار و تاریخ بیمارگیری
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
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Having a chestCOVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive 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 physicianScan Having consent to participate in the intervention
داشتن سی تی اسکن از قفسه سینه که ابتلا به Covid 19 را تایید کند
داشتن علایم بالینی covid 19 شامل تب، درد عضلانی، تنگی نفس، سرفه خشک، گلودرد،آبریزش بینی
تایید ابتلا به covid19 توسط پزشک متخصص عفونی
داشتن رضایت به شرکت در مداخله
بیماران مبتلا به covid-19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت دارند.
داشتن رضایت به شرکت در مداخله
داشتن سی تی اسکن از قفسه سینهبیماران مبتلا به covid-19 که ابتلابیماری آنها به Covid 19 را تایید کند داشتن علایم بالینی covid 19 شامل تب، درد عضلانی، تنگی نفس، سرفه خشک، گلودرد،آبریزش بینی تایید ابتلا به covid19 توسط پزشک متخصص عفونیوسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت دارند. داشتن رضایت به شرکت در مداخله
Pregnant and lactating women
Those taking losartan and captopril.
Those with a history of intestinal ulcers or gastrointestinal bleeding.
Children under 14 years
pregnant or breast feeding women
Those taking losartan and captopril.
Those with a history of intestinal ulcers or gastrointestinal bleeding.
Children under 14 years
Pregnant and lactatingpregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years
Primary outcomes
#1
fever
Time to clinical improvement defined as start of taking medication time to the next 28 days.
feverTime to clinical improvement defined as start of taking medication time to the next 28 days.
تب
زمان بهبود علائم بالینی که از زمان شروع مصرف دارو تا 28 روز بعد در نظر گرفته می شود.
تبزمان بهبود علائم بالینی که از زمان شروع مصرف دارو تا 28 روز بعد در نظر گرفته می شود.
At the time of positive test and 14 days later
The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
AtThe beginning of the time of positive test and 14 days laterstudy ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
زمان مثبت شدن تست کرونا-ابتدای مطالعه، روز 7 ، روز 14 ، روز بعد از زمان مثبت شدن تست21 و روز 28
Using oral thermometer
Medical record
Using oral thermometerMedical record
با استفاده از دماسنج دهانی
پرونده بیمار
با استفاده از دماسنج دهانیپرونده بیمار
#2
Cough
empty
Cough
سرفه
empty
سرفه
At the time of positive test and 14 days later
empty
At the time of positive test and 14 days later
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
empty
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
Clinical observation and examination
empty
Clinical observation and examination
مشاهده و معاینه بالینی
empty
مشاهده و معاینه بالینی
#3
Chills
empty
Chills
لرز
empty
لرز
At the time of positive test and 14 days later
empty
At the time of positive test and 14 days later
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
empty
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
Clinical observation and examination
empty
Clinical observation and examination
مشاهده و معاینه بالینی
empty
مشاهده و معاینه بالینی
#4
Night sweats
empty
Night sweats
تعریق شبانه
empty
تعریق شبانه
At the time of positive test and 14 days later
empty
At the time of positive test and 14 days later
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
empty
زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
The beginning of the study and the time of discharge
The beginning of the study and the time of discharge
empty
ابتدای مطالعه و زمان ترخیص
ابتدای مطالعه و زمان ترخیص
empty
Medical record
Medical record
empty
پرونده بیمار
پرونده بیمار
#5
empty
Cough
Cough
empty
سرفه
سرفه
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
Clinical observation and examination
Clinical observation and examination
empty
مشاهده و معاینه بالینی
مشاهده و معاینه بالینی
#6
empty
shortness of breath
shortness of breath
empty
تنگی نفس
تنگی نفس
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
Clinical observation and examination
Clinical observation and examination
empty
مشاهده و معاینه بالینی
مشاهده و معاینه بالینی
#7
empty
Fatigue
Fatigue
empty
خستگی
خستگی
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
Clinical observation and Interview with the patient
Clinical observation and Interview with the patient
empty
مشاهده و مصاحبه با بیمار
مشاهده و مصاحبه با بیمار
#8
empty
Diarrhea
Diarrhea
empty
اسهال
اسهال
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
Interview with the patient
Interview with the patient
empty
مصاحبه با بیمار
مصاحبه با بیمار
#9
empty
Body pain
Body pain
empty
بدن درد
بدن درد
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
Interview with the patient
Interview with the patient
empty
مصاحبه با بیمار
مصاحبه با بیمار
#10
empty
The patient's condition is based on inpatient or outpatient
The patient's condition is based on inpatient or outpatient
empty
وضعیت بیمار بر اساس بستری یا سرپایی
وضعیت بیمار بر اساس بستری یا سرپایی
empty
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
empty
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
empty
seven category ordinal scale
seven category ordinal scale
empty
مقیاس ترتیبی هفت طبقه
مقیاس ترتیبی هفت طبقه
Sharing plan
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
No more information.
empty
No more information.
اطلاعات بیشتری وجود ندارد.
empty
اطلاعات بیشتری وجود ندارد.
empty
-All data can be shared after the participants in the study are unrecognizable.
-All data can be shared after the participants in the study are unrecognizable.
empty
کل داده ها پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است.
کل داده ها پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است.
empty
The data access period after printing the article
The data access period after printing the article
empty
شروع دوره دسترسی به داده ها بعد از چاپ مقاله
شروع دوره دسترسی به داده ها بعد از چاپ مقاله
empty
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
empty
داده های این مطالعه برای محققین شاغل در موسسات دانشگاهی و علمی و همچنین سازمان غذا و دارو قابل دسترس خواهد بود.
داده های این مطالعه برای محققین شاغل در موسسات دانشگاهی و علمی و همچنین سازمان غذا و دارو قابل دسترس خواهد بود.
empty
- Any analysis can be done with the consent of the main researcher.
- Any analysis can be done with the consent of the main researcher.
empty
انجام هر گونه آنالیز با رضایت محقق اصلی میتواند انجام شود.
انجام هر گونه آنالیز با رضایت محقق اصلی میتواند انجام شود.
empty
s.mobarak@abadanums.ac.ir
s.mobarak@abadanums.ac.ir
empty
s.mobarak@abadanums.ac.ir
s.mobarak@abadanums.ac.ir
empty
-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.
-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.
empty
- فرد محقق و یا شرکت دارویی بعد از ارسال مستندات جهت تایید هویت اصلی خود می تواند درخواست خود را به ایمیل آکادمیک ارسال نماید. سپس مجری طرح بعد از کسب اطمینان از صحت مستندات ارسالی پس از بازه زمانی یک هفته اطلاعات درخواست شده را در اختیار فرد محقق و یا شرکت دارویی قرار خواهد داد.
- فرد محقق و یا شرکت دارویی بعد از ارسال مستندات جهت تایید هویت اصلی خود می تواند درخواست خود را به ایمیل آکادمیک ارسال نماید. سپس مجری طرح بعد از کسب اطمینان از صحت مستندات ارسالی پس از بازه زمانی یک هفته اطلاعات درخواست شده را در اختیار فرد محقق و یا شرکت دارویی قرار خواهد داد.
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 80. 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: COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Exclusion criteria: pregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years
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
Edit publication list and date of recruitment
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046850N3
Registration date:2020-03-30, 1399/01/11
Registration timing:prospective
Last update:2020-05-18, 1399/02/29
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
2020-04-20, 1399/02/01
Expected recruitment end date
2020-05-20, 1399/02/31
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:
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Exclusion criteria:
pregnant or breast feeding 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:
80
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
Time to clinical improvement defined as start of taking medication time to the next 28 days.
Timepoint
The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
The beginning of the study and the time of discharge
Method of measurement
Medical record
5
Description
Cough
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Clinical observation and examination
6
Description
shortness of breath
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Clinical observation and examination
7
Description
Fatigue
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Clinical observation and Interview with the patient
8
Description
Diarrhea
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Interview with the patient
9
Description
Body pain
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Interview with the patient
10
Description
The patient's condition is based on inpatient or outpatient
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
seven category ordinal scale
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)
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
-All data can be shared after the participants in the study are unrecognizable.
When the data will become available and for how long
The data access period after printing the article
To whom data/document is available
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
Under which criteria data/document could be used
- Any analysis can be done with the consent of the main researcher.
From where data/document is obtainable
s.mobarak@abadanums.ac.ir
What processes are involved for a request to access data/document
-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.