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Protocol summary
The randomized clinical trial with two parallel groups in which 100 patients will be enrolled between 18 April 2020 till 19 June 2020
The randomized clinical trial with two parallel groups; without blinding, in which 200 patients will be enrolled between 18 April 2020 till 19 June 2020
The randomized clinical trial with two parallel groups; without blinding, in which 100200 patients will be enrolled between 18 April 2020 till 19 June 2020
کارآزمایی بالینی تصادفی شده دارای دو گروه موازی، مبتنی بر 100 بیمار مبتلا به ویروس کرونا که از 30 فروردین 99 تا 30 خرداد وارد مطالعه می شوند.
کارآزمایی بالینی تصادفی شده دارای دو گروه موازی، بدون کورسازی، مبتنی بر 200 بیمار مبتلا به ویروس کرونا که از 30 فروردین 99 تا 30 خرداد وارد مطالعه می شوند.
کارآزمایی بالینی تصادفی شده دارای دو گروه موازی، بدون کورسازی، مبتنی بر 100200 بیمار مبتلا به ویروس کرونا که از 30 فروردین 99 تا 30 خرداد وارد مطالعه می شوند.
This study will be performed at Masih Daneshvari Hospital, Tehran, Iran.
In this study, 100 patients will be enrolled based on inclusion and exclusion criteria and divided into two groups (50 in each group) by simple randomization.
Patients in the control group will receive a standard regimen for COVID-19.
Patients in the Formoterol group will receive one dose of inhaled formoterol drug twice daily for two weeks along with the standard regimen for COVID-19.
The routine lab data, disease duration, and mortality rate will be assessed in both groups.
200 eligible patients will be divided into two groups by simple randomization.
Patients in the Formoterol group will receive one dose of inhaled formoterol twice daily for 10 days along with the national protocol for COVID-19.
Disease duration, the mortality rate, and the rate of symptom improvement at the 5th and 10th day based on Complete improvement, Partial improvement, lack of improvement and admission, will be assessed for 30 days.
This study will be performed at Masih Daneshvari Hospital, Tehran, Iran. In this study, 100200 eligible patients will be enrolled based on inclusion and exclusion criteria and divided into two groups (50 in each group) by simple randomization. Patients in the control group will receive a standard regimen for COVID-19. Patients in the Formoterol group will receive one dose of inhaled formoterol drug twice daily for two weeks10 days along with the standard regimennational protocol for COVID-19. The routine lab data, diseaseDisease duration, andthe mortality rate, and the rate of symptom improvement at the 5th and 10th day based on Complete improvement, Partial improvement, lack of improvement and admission, will be assessed in both groupsfor 30 days.
این مطالعه در بیمارستان مسیح دانشوری تهران، ایران، انجام خواهد شد. در این مطالعه 100 بیمار واجد شرایط که با علائم بیماری کرونا مراجعه خواهند کرد انتخاب شده و به صورت تصادفی ساده در دو گروه 50 نفری قرار خواهند گرفت.
بیماران در گروه کنترل رژیم استاندارد درمان کروناویروس را دریافت خواهند کرد. بیماران در گروه فورموترول، علاوه بر رژیم استاندارد به مدت حداقل 2 هفته تحت درمان با یک دوز دارو دو بار در روز قرار خواهند گرفت.
آزمایشات روتین خونی، طول مدت بهبودی و مرگ و میر بررسی خواهند شد.
200 بیمار واجد شرایط به صورت تصادفی ساده بر اساس اعداد زوج و فرد در دو گروه قرار خواهند گرفت.
بیماران گروه فورموترول، ( به مدت ده روز، یک دوز دارو دو بار در روز) بعلاوه درمان اصلی را دریافت می کنند.
نرخ بهبود علایم در روزهای 5 و 10 ، طول بیماری و نرخ مرگ و میر در بازه ی زمانی 30 روزه بررسی خواهند شد.
این مطالعه در بیمارستان مسیح دانشوری تهران، ایران، انجام خواهد شد. در این مطالعه 100200 بیمار واجد شرایط که با علائم بیماری کرونا مراجعه خواهند کرد انتخاب شده و به صورت تصادفی ساده بر اساس اعداد زوج و فرد در دو گروه 50 نفری قرار خواهند گرفت. بیماران در گروه کنترل رژیم استاندارد درمان کروناویروس را دریافت خواهند کرد. بیماران در گروه فورموترول، علاوه بر رژیم استاندارد( به مدت حداقل 2 هفته تحت درمان باده روز، یک دوز دارو دو بار در روز قرار خواهند گرفت) بعلاوه درمان اصلی را دریافت می کنند. آزمایشات روتین خونینرخ بهبود علایم در روزهای 5 و 10 ، طول مدت بهبودیبیماری و نرخ مرگ و میر در بازه ی زمانی 30 روزه بررسی خواهند شد.
-Patients aged 18 to 75 years old
-Both Sexes
-COVID-19 patients based on clinical manifestations
or according to CBC, CRP, and Chest radiography or other lab tests
-patients who voluntarily agree to participate in the study after being fully informed about it and sign the consent form.
-Patients aged 18 to 75 years old
-Both Sexes
-COVID-19 patients based on clinical manifestations
or according to CBC, CRP, and Chest radiography or other lab tests
-patients who voluntarily agree to participate in the study after being fully informed about it and sign the consent form.
In the case of Pregnancy, Comorbidity, Saturation less than 93% or any criteria for hospitalization, History of formoterol intolerance, Cardiac diseases, such as heart failure or arrhythmia, Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors, Asthma or a history of Chronic obstructive pulmonary disease (COPD), Heavy smoking, the patient will be excluded.
-Patients aged 18 to 75 years old -Both Sexes -COVID-19 patients based on clinical manifestations or according to CBC, CRP, and Chest radiography or other lab tests -patients who voluntarily agree to participate in the study after being fully informed about it and sign the consent form. In the case of Pregnancy, Comorbidity, Saturation less than 93% or any criteria for hospitalization, History of formoterol intolerance, Cardiac diseases, such as heart failure or arrhythmia, Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors, Asthma or a history of Chronic obstructive pulmonary disease (COPD), Heavy smoking, the patient will be excluded.
بیماران 18 تا 75 ساله
هر دو جنس
مبتلایان به (COVID-19) که با توجه به تظاهرات بالینی CBC ، CRP و رادیوگرافی قفسه سینه یا سایر تست های آزمایشگاهی تأیید شده اند.
بیمارانی که داوطلبانه برای شرکت در طرح موافقت کردند و پس از ارایه اطلاعات لازم، فرم رضایت را امضا می کنند.
بیماران 18 تا 75 ساله
هر دو جنس
مبتلایان به (COVID-19) که با توجه به تظاهرات بالینی CBC ، CRP و رادیوگرافی قفسه سینه یا سایر تست های آزمایشگاهی تأیید شده اند.
بیمارانی که داوطلبانه برای شرکت در طرح موافقت می کنند و پس از ارایه اطلاعات لازم، فرم رضایت را امضا می کنند.
در موارد بارداری ، وجود بیماری همراه، اشباع اکسیژن خون کمتر از 93٪ یا هر معیار بستری در بیمارستان ، سابقه عدم تحمل فرموترول ، بیماری های قلبی مانند نارسایی قلبی یا آریتمی ، سابقه اخیر استفاده از کورتیکواستروئیدهای استنشاقی ، گشادکننده های برونش و مهار کننده های ACE ، وجود آسم یا یک سابقه بیماری انسدادی مزمن ریوی (COPD) و سیگار کشیدن شدید ، بیمار از مطالعه خارج می شود.
بیماران 18 تا 75 ساله هر دو جنس مبتلایان به (COVID-19) که با توجه به تظاهرات بالینی CBC ، CRP و رادیوگرافی قفسه سینه یا سایر تست های آزمایشگاهی تأیید شده اند. بیمارانی که داوطلبانه برای شرکت در طرح موافقت کردندمی کنند و پس از ارایه اطلاعات لازم، فرم رضایت را امضا می کنند. در موارد بارداری ، وجود بیماری همراه، اشباع اکسیژن خون کمتر از 93٪ یا هر معیار بستری در بیمارستان ، سابقه عدم تحمل فرموترول ، بیماری های قلبی مانند نارسایی قلبی یا آریتمی ، سابقه اخیر استفاده از کورتیکواستروئیدهای استنشاقی ، گشادکننده های برونش و مهار کننده های ACE ، وجود آسم یا یک سابقه بیماری انسدادی مزمن ریوی (COPD) و سیگار کشیدن شدید ، بیمار از مطالعه خارج می شود.
1- Inhaled Formoterol
In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 7 days.
2- Control group: receive standard regimen for COVID-19 according to national protocol.
1- Inhaled Formoterol
In this group along with the national regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 10 days.
2- Control group: receive national regimen for COVID-19 according to national protocol.
1- Inhaled Formoterol In this group along with the standardnational regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 710 days. 2- Control group: receive standardnational regimen for COVID-19 according to national protocol.
1- گروه فورموترول استنشاقی
در این گروه همراه با رژیم استاندارد COVID-19 که طبق دستورالعمل ملی تجویز می شود، بیماران هر 12 ساعت یکبار به مدت 7 روز 1 پاف از فرم استنشاقی فرموتررول استفاده می کنندکه ساخت شرکت Medochemie است.
2- گروه کنترل:
این گروه فقط درمان استاندارد را طبق پروتکل کشوری دریافت می کنند.
1- گروه فورموترول استنشاقی
در این گروه همراه با رژیم استاندارد COVID-19 که طبق دستورالعمل ملی تجویز می شود، بیماران هر 12 ساعت یکبار به مدت 10 روز 1 پاف از فرم استنشاقی فرموتررول استفاده می کنندکه ساخت شرکت Medochemie است.
2- گروه کنترل:
این گروه فقط درمان تاییده ملی را طبق پروتکل کشوری دریافت می کنند.
1- گروه فورموترول استنشاقی در این گروه همراه با رژیم استاندارد COVID-19 که طبق دستورالعمل ملی تجویز می شود، بیماران هر 12 ساعت یکبار به مدت 710 روز 1 پاف از فرم استنشاقی فرموتررول استفاده می کنندکه ساخت شرکت Medochemie است. 2- گروه کنترل: این گروه فقط درمان استانداردتاییده ملی را طبق پروتکل کشوری دریافت می کنند.
Recovery of Pneumonia
five-day symptom improvement;
10-day symptom improvement;
Total time since randomization until clinical improvement.
Recovery of Pneumoniafive-day symptom improvement; 10-day symptom improvement; Total time since randomization until clinical improvement.
بهبودی از بیماری
میزان بهبودی در روز 5;
میزان بهبودی در روز 10;
طول دوره بیماری تا بهبودی.
میزان بهبودی ازدر روز 5; میزان بهبودی در روز 10; طول دوره بیماری تا بهبودی.
General information
50
200
50200
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For the title, respiratory symptoms were considered, thus, the title was revised.
During the Implementation of the trial, exclusion criteria were expanded; so, this part of the protocol was amended. Some exclusion criteria such as asthma and cardiac disease were added.
The sample size was increased to have more similarity in baseline characteristics in treatment and control groups. In each arm. 100 participants were considered.
The trial was multicenter, so all recruit centers were added.
For the title, respiratory symptoms were considered, thus, the title was revised. During the Implementation of the trial, exclusion criteria were expanded; so, this part of the protocol was amended. Some exclusion criteria such as asthma and cardiac disease were added. The sample size was increased to have more similarity in baseline characteristics in treatment and control groups. In each arm. 100 participants were considered. The trial was multicenter, so all recruit centers were added.
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برای عنوان ، علائم تنفسی در نظر گرفته شد ، بنابراین ، عنوان اصلاح شد.
در طول اجرای مطالعه ، معیارهای خروج گسترش یافت. بنابراین ، این قسمت از پروتکل اصلاح شد. مواردی مانند سابقه اسم و بیناری قلبی به این موارد اضافه شد.
حجم نمونه افزایش یافت تا شباهت بیشتری در مشخصات پایه دو گروه مداخله و کنترل داشته باشیم.در هر بازو ۱۰۰بیمار در نظر گرفته شد.
مطالعه چند مرکزی بود لذا تمام مراکز فراخوانی بیماران به روز شد.
برای عنوان ، علائم تنفسی در نظر گرفته شد ، بنابراین ، عنوان اصلاح شد. در طول اجرای مطالعه ، معیارهای خروج گسترش یافت. بنابراین ، این قسمت از پروتکل اصلاح شد. مواردی مانند سابقه اسم و بیناری قلبی به این موارد اضافه شد. حجم نمونه افزایش یافت تا شباهت بیشتری در مشخصات پایه دو گروه مداخله و کنترل داشته باشیم.در هر بازو ۱۰۰بیمار در نظر گرفته شد. مطالعه چند مرکزی بود لذا تمام مراکز فراخوانی بیماران به روز شد.
Pregnancy
Comorbidity
Saturation less than 93%
The presence of symptoms for more than 2 days
Pregnancy
Comorbidity
Saturation less than 93%
The presence of symptoms for more than 7 days
History of formoterol intolerance
cardiac diseases, such as heart failure or arrhythmia
Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors
Asthma or COPD
Heavy Smoker
Pregnancy Comorbidity Saturation less than 93% The presence of symptoms for more than 27 days History of formoterol intolerance cardiac diseases, such as heart failure or arrhythmia Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors Asthma or COPD Heavy Smoker
حاملگی
بیماری های همراه
اشباع اکسیژن کمتر از 93 درصد
از شروع علایم بیش از 2 روز گدشته باشد
حاملگی
بیماری های همراه
اشباع اکسیژن کمتر از 93 درصد
از شروع علایم بیش از 7 روز گدشته باشد
سابقه عدم تحمل فورموترول
بیماری های قلبی از قبیل نارسایی قلبی و یا آریتمی
سابقه اخیر استفاده از کورتیکواستروئیدهای استنشاقی ، گشادکننده برونش و مهارکننده های ACE
آسم یا بیماری انسدادی مزمن تنفسی
سیگاری قهار
حاملگی بیماری های همراه اشباع اکسیژن کمتر از 93 درصد از شروع علایم بیش از 27 روز گدشته باشد سابقه عدم تحمل فورموترول بیماری های قلبی از قبیل نارسایی قلبی و یا آریتمی سابقه اخیر استفاده از کورتیکواستروئیدهای استنشاقی ، گشادکننده برونش و مهارکننده های ACE آسم یا بیماری انسدادی مزمن تنفسی سیگاری قهار
clinical evaluation, observation, physical examination, and call interview for follow up
clinical evaluation, observation, physical examination, and call interview for follow up
پیگیری با تماس تلفنی
بررسی بالینی، معاینه، مشاهده و پیگیری با تماس تلفنی
بررسی بالینی، معاینه، مشاهده و پیگیری با تماس تلفنی
#2
Relapse and re visiting
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Relapse and re visiting
• میزان مراجعه مجدد بیمار به علت عدم درمان در 10 روز اول پس از درمان اولیه
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• میزان مراجعه مجدد بیمار به علت عدم درمان در 10 روز اول پس از درمان اولیه
10 days
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10 days
ده روز
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ده روز
observation
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observation
مشاهده
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مشاهده
Secondary outcomes
#1
Percentage of convert CRP to negative in case of positive ones
Total time to improvement
Percentage of convert CRPTotal time to negative in case of positive onesimprovement
درصد مورادی که CRP منفی می شود.
کل طول دوره ی بیماری
درصد مورادی که CRP منفی می شود.کل طول دوره ی بیماری
14 days
up to 30 days follow-up
14up to 30 days follow-up
14 روز
تا 30 روز پیگیری
14تا 30 روز پیگیری
lab test
observation
lab testobservation
ازمایش خون
مشاهده
ازمایش خونمشاهده
#2
correction of Lymphopenia
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correction of Lymphopenia
اصلاح لنفوپنی
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اصلاح لنفوپنی
14 days
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14 days
14 روز
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14 روز
lab test
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lab test
lab test
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lab test
Intervention groups
#1
Intervention group: Inhaled Formoterol، In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol 1 Puff every 12 hours made by Medochemie Company for 7 days.
Intervention group: Inhaled Formoterol، In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol 1 Puff every 12 hours made by Medochemie Company for 10 days.
Intervention group: Inhaled Formoterol، In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol 1 Puff every 12 hours made by Medochemie Company for 710 days.
گروه مداخله: فورموترول استنشاقی، در این گروه همراه با رژیم استاندارد طبق دستورالعمل ملی درمان COVID-19 ، بیماران هر 12 ساعت یکبار به مدت 7 روز از فرموترول استنشاقی شرکت Medochemie به میزان 1 پاف استفاده می کنند.
گروه مداخله: فورموترول استنشاقی، در این گروه همراه با رژیم استاندارد طبق دستورالعمل ملی درمان COVID-19 ، بیماران هر 12 ساعت یکبار به مدت 10 روز از فرموترول استنشاقی شرکت Medochemie به میزان 1 پاف استفاده می کنند.
گروه مداخله: فورموترول استنشاقی، در این گروه همراه با رژیم استاندارد طبق دستورالعمل ملی درمان COVID-19 ، بیماران هر 12 ساعت یکبار به مدت 710 روز از فرموترول استنشاقی شرکت Medochemie به میزان 1 پاف استفاده می کنند.
#2
گروه کنترل: فقط رژیم استاندارد طبق پروتکل
گروه کنترل: فقط رژیم تایید شده درمانی طبق پروتکل
گروه کنترل: فقط رژیم استانداردتایید شده درمانی طبق پروتکل
Recruitment centers
#1
Name of recruitment center - English: Qum
Name of recruitment center - Persian: قم
Full name of responsible person - English: Abolfazl Mozafari
Full name of responsible person - Persian: ابوالفضل مظفری
Street address - English: Islamic Azad University of Qom , 15-Khordad hospital,
Street address - Persian: بلوار ۱۵ خرداد، دانشگاه آزاد اسلامی قم
City - English: Qum
City - Persian: قم
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 3749113191
Phone: +98 25 3280 7070
Fax:
Email: a_mozafari@hotmail.com
Web page address:
Name of recruitment center - English: Qum Name of recruitment center - Persian: قم Full name of responsible person - English: Abolfazl Mozafari Full name of responsible person - Persian: ابوالفضل مظفری Street address - English: Islamic Azad University of Qom , 15-Khordad hospital, Street address - Persian: بلوار ۱۵ خرداد، دانشگاه آزاد اسلامی قم City - English: Qum City - Persian: قم Province: Tehran Country: Iran (Islamic Republic of) Postal code: 3749113191 Phone: +98 25 3280 7070 Fax: Email: a_mozafari@hotmail.com Web page address:
#2
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: بیمارستان رازی
Full name of responsible person - English: Azita Tangestani Nejad
Full name of responsible person - Persian: آزیتا تنگستانی نژاد
Street address - English: Razi Medical Cente, RSardar Jangal St.
Street address - Persian: خیابان سردار جنگل-مرکز آموزشی درمانی رازی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 41448
Phone: +98 31 3355 0028
Fax:
Email: aznejad@yahoo.com
Web page address:
Name of recruitment center - English: Razi Hospital Name of recruitment center - Persian: بیمارستان رازی Full name of responsible person - English: Azita Tangestani Nejad Full name of responsible person - Persian: آزیتا تنگستانی نژاد Street address - English: Razi Medical Cente, RSardar Jangal St. Street address - Persian: خیابان سردار جنگل-مرکز آموزشی درمانی رازی City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 41448 Phone: +98 31 3355 0028 Fax: Email: aznejad@yahoo.com Web page address:
#3
Name of recruitment center - English: Semnan University of medical sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی سمنان
Full name of responsible person - English: Mahboobeh Darban
Full name of responsible person - Persian: محبوبه دربان
Street address - English: Bassij Blvd, Headquarter of Semnan University of Medical Sciences and Health Services
Street address - Persian: ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی سمنان ، بلوار بسیج
City - English: Semnan
City - Persian: سمنان
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 35147-99442
Phone: +98 23 3345 2199
Fax:
Email: Dr.mdarban@gmail.com
Web page address:
Name of recruitment center - English: Semnan University of medical sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی سمنان Full name of responsible person - English: Mahboobeh Darban Full name of responsible person - Persian: محبوبه دربان Street address - English: Bassij Blvd, Headquarter of Semnan University of Medical Sciences and Health Services Street address - Persian: ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی سمنان ، بلوار بسیج City - English: Semnan City - Persian: سمنان Province: Markazi Country: Iran (Islamic Republic of) Postal code: 35147-99442 Phone: +98 23 3345 2199 Fax: Email: Dr.mdarban@gmail.com Web page address:
Sponsors / Funding sources
#1
empty
Yes
1
Industry
Academic
industryacademic
pharmacy
National Research Institute of Tuberculosis and Lung Diseases
pharmacyNational Research Institute of Tuberculosis and Lung Diseases
شرکت دارویی
پژوهشکده سل و بیماری های ریوی
شرکت داروییپژوهشکده سل و بیماری های ریوی
#2
contact.organization_id:
Name of organization / entity - English: Medochemie KSN
Name of organization / entity - Persian: شرکت مدوشیمی
Full name of responsible person - English: Farzaneh Rahatlou
Full name of responsible person - Persian: فرزانه راحتلو
Street address - English: No. 30, Dameshgh Street, Valiasr Street,
Street address - Persian: خیابان ولیعصر، خیابان دمشق، پلاک 30
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416743147
Phone: +98 21 8892 8041
Fax:
Email: rahatlou@nikanmedicalgroup.com
Web page address:
contact.organization_id: Name of organization / entity - English: Medochemie KSN Name of organization / entity - Persian: شرکت مدوشیمی Full name of responsible person - English: Farzaneh Rahatlou Full name of responsible person - Persian: فرزانه راحتلو Street address - English: No. 30, Dameshgh Street, Valiasr Street, Street address - Persian: خیابان ولیعصر، خیابان دمشق، پلاک 30 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416743147 Phone: +98 21 8892 8041 Fax: Email: rahatlou@nikanmedicalgroup.com Web page address:
empty
Yes
1
empty
50
50
empty
Private
private
empty
Domestic
domestic
empty
Industry
industry
empty
Medochemie KSN
Medochemie KSN
empty
شرکت مدوشیمی
شرکت مدوشیمی
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: National Research Institute of Tuberculosis and Lung Diseases
Name of organization / entity - Persian: پژوهشکده سل و بیماری های ریوی
Full name of responsible person - English: Fariba Ghorbani
Full name of responsible person - Persian: Fariba Ghorbani
Position - English: Researcher
Position - Persian: محقق
Latest degree: phd
Area of specialty/work: 83
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Daraabaad, Niavaran
Street address - Persian: نیاوران، داراباد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1956744413
Phone: +98 21 2712 2163
Mobile: +98 912 422 2913
Fax:
Email: dr.f.ghorbani@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: National Research Institute of Tuberculosis and Lung Diseases
Name of organization / entity - Persian: پژوهشکده سل و بیماری های ریوی
Full name of responsible person - English: Fariba Ghorbani
Full name of responsible person - Persian: فریبا قربانی
Position - English: Researcher
Position - Persian: محقق
Latest degree: phd
Area of specialty/work: 83
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 1,Daraabaad, Niavaran
Street address - Persian: نیاوران، داراباد، پلاک1
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1956744413
Phone: +98 21 2712 2163
Mobile: +98 912 422 2913
Fax:
Email: dr.f.ghorbani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: National Research Institute of Tuberculosis and Lung Diseases Name of organization / entity - Persian: پژوهشکده سل و بیماری های ریوی Full name of responsible person - English: Fariba Ghorbani Full name of responsible person - Persian: Fariba Ghorbaniفریبا قربانی Position - English: Researcher Position - Persian: محقق Latest degree: phd Area of specialty/work: 83 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: DaraabaadNo. 1,Daraabaad, Niavaran Street address - Persian: نیاوران، داراباد، پلاک1 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1956744413 Phone: +98 21 2712 2163 Mobile: +98 912 422 2913 Fax: Email: dr.f.ghorbani@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of the effectiveness of inhaled formoterol to improve respiratory symptoms of COVID 19 patients.
Design
The randomized clinical trial with two parallel groups; without blinding, in which 200 patients will be enrolled between 18 April 2020 till 19 June 2020
Settings and conduct
200 eligible patients will be divided into two groups by simple randomization.
Patients in the Formoterol group will receive one dose of inhaled formoterol twice daily for 10 days along with the national protocol for COVID-19.
Disease duration, the mortality rate, and the rate of symptom improvement at the 5th and 10th day based on Complete improvement, Partial improvement, lack of improvement and admission, will be assessed for 30 days.
Participants/Inclusion and exclusion criteria
-Patients aged 18 to 75 years old
-Both Sexes
-COVID-19 patients based on clinical manifestations
or according to CBC, CRP, and Chest radiography or other lab tests
-patients who voluntarily agree to participate in the study after being fully informed about it and sign the consent form.
In the case of Pregnancy, Comorbidity, Saturation less than 93% or any criteria for hospitalization, History of formoterol intolerance, Cardiac diseases, such as heart failure or arrhythmia, Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors, Asthma or a history of Chronic obstructive pulmonary disease (COPD), Heavy smoking, the patient will be excluded.
Intervention groups
1- Inhaled Formoterol
In this group along with the national regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 10 days.
2- Control group: receive national regimen for COVID-19 according to national protocol.
Main outcome variables
five-day symptom improvement;
10-day symptom improvement;
Total time since randomization until clinical improvement.
General information
Reason for update
For the title, respiratory symptoms were considered, thus, the title was revised.
During the Implementation of the trial, exclusion criteria were expanded; so, this part of the protocol was amended. Some exclusion criteria such as asthma and cardiac disease were added.
The sample size was increased to have more similarity in baseline characteristics in treatment and control groups. In each arm. 100 participants were considered.
The trial was multicenter, so all recruit centers were added.
Acronym
IRCT registration information
IRCT registration number:IRCT20170210032478N3
Registration date:2020-04-29, 1399/02/10
Registration timing:registered_while_recruiting
Last update:2021-01-02, 1399/10/13
Update count:1
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2163
Email address
dr.f.ghorbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of inhaled formoterol on symptom improvement in covid 19 patients
Public title
Effect of Formoterol in treatment of covid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(COVID-19) with according to the clinical manifestations confirmed with CBC, CRP, and Chest radiography or other lab tests
Patients who voluntarily sign our consent form.
Exclusion criteria:
Pregnancy
Comorbidity
Saturation less than 93%
The presence of symptoms for more than 7 days
History of formoterol intolerance
cardiac diseases, such as heart failure or arrhythmia
Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors
Asthma or COPD
Heavy Smoker
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Using even and odd numbers, the patients are simply randomized and placed in two groups of intervention and (no- intervention).
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
Ethics committee of National Research Institute of Tuberculosis and Lung Diseases
Street address
Niavaran, Daaraabaad
City
Tehran
Province
Tehran
Postal code
1956744413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.003
Health conditions studied
1
Description of health condition studied
corona virus or COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
2
Description of health condition studied
COVID 19 ,virus not identified
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Level of Improvement
Timepoint
the 5th and 10th days
Method of measurement
clinical evaluation, observation, physical examination, and call interview for follow up
Secondary outcomes
1
Description
Total time to improvement
Timepoint
up to 30 days follow-up
Method of measurement
observation
Intervention groups
1
Description
Intervention group: Inhaled Formoterol، In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol 1 Puff every 12 hours made by Medochemie Company for 10 days.
Category
Treatment - Drugs
2
Description
Control group: standard treatment according to protocol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Giti Pourdoulat
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Fax
+98 21 2610 5387
Email
pourdowlat_g@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Qum
Full name of responsible person
Abolfazl Mozafari
Street address
Islamic Azad University of Qom , 15-Khordad hospital,
City
Qum
Province
Tehran
Postal code
3749113191
Phone
+98 25 3280 7070
Email
a_mozafari@hotmail.com
Web page address
3
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Azita Tangestani Nejad
Street address
Razi Medical Cente, RSardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 31 3355 0028
Email
aznejad@yahoo.com
Web page address
4
Recruitment center
Name of recruitment center
Semnan University of medical sciences
Full name of responsible person
Mahboobeh Darban
Street address
Bassij Blvd, Headquarter of Semnan University of Medical Sciences and Health Services
City
Semnan
Province
Markazi
Postal code
35147-99442
Phone
+98 23 3345 2199
Email
Dr.mdarban@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Parisa Farnia
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2009
Email
tdrc.nritld@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Research Institute of Tuberculosis and Lung Diseases
Proportion provided by this source
50
Public or private sector
Private
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
Medochemie KSN
Full name of responsible person
Farzaneh Rahatlou
Street address
No. 30, Dameshgh Street, Valiasr Street,
City
Tehran
Province
Tehran
Postal code
1416743147
Phone
+98 21 8892 8041
Email
rahatlou@nikanmedicalgroup.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medochemie KSN
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Fariba Ghorbani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 1,Daraabaad Ave., Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Email
dr.f.ghorbani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Guitti Pourdowlat
Position
Assistant Proffessore
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonologyst
Street address
Niavaran, Daraabaad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Email
pourdowlat_g@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Fariba Ghorbani
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
No. 1,Daraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956744413
Phone
+98 21 2712 2163
Email
dr.f.ghorbani@gmail.com
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