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Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients

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History
# Registration date Revision Id
2 2020-06-22, 1399/04/02 140914
1 2020-05-16, 1399/02/27 134529
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  • Protocol summary

    Comparing efficacy of interferon beta 1a nasal spray and placebo for Time to Clinical Recovery of Covid-19 (Fever normalization and oxygen saturation sustained for at least 72 hours)
    Evaluation of 50% reduction of viral load or negative results of virus before Day 7
    مقایسه اثربخشی اسپری بینی اینترفرون بتا 1آ و داروی پلاسبو برای بهبود کلینیکال علایم بیماری کووید-19(نرمال شدن تب و غلظت اشباع اکسیژن به مدت 72 ساعت)
    بررسی کاهش 50 درصدی میزان لود ویروس و یا منفی شدن آن تا قبل روز 7 درمان
    This is a randomized double blind study at Baqiyatallal Hospital at mild to moderate cases of covid-19. Nasal spray of interferon beta 1a will be prepared by sponsor of the study (Cinnagen), the package of the test and placebo drug will have totally equal shape and size. The drugs will be coded by randomization code which was prepared by an independent statistical person. The dosage of the drug or placebo: One puff at each nostril, every 6 hours, for 14 days
    This is a randomized double blind study at Baqiyatallal Hospital and other centers of the study at hospitalized covid-19 patients. Nasal spray of interferon beta 1a will be prepared by sponsor of the study (CinnaGen), the package of the test and placebo drug will have totally equal shape and size. The drugs will be coded by randomization code which was prepared by an independent statistical person. The dosage of the drug or placebo: One puff at each nostril, every 6 hours, for 7 days
    این مطالعه یک کارآزمایی بالینی دو سو کور می باشد که در بیمارستان بقیه الله بر روی بیماران خفیف تا متوسط کووید-19 انجام خواهد گرفت. اسپری بینی حاوی اینترفرون بتا 1 آ توسط شرکت دارویی آماده و در اختیار محققین مطالعه قرار می گیرد. داروها توسط شرکت دارویی در بسته بندی و شکل دارویی کاملا یکسان در اختیار کادر درمانی قرار می گیرد و براساس کدهای رندومیزاسیون که توسط گروه آمار مستقل تهیه شده است، به بیماران اختصاص داده خواهد شد. دستور مصرف: یک اسپری در هر سوراخ بینی روزانه هر 6 ساعت که توسط بیمار صورت میگیرد. طول مدت درمان با اسپری بینی به مدت 14 روز می باشد.
    این مطالعه یک کارآزمایی بالینی دو سو کور می باشد که در بیمارستان بقیه الله و سایر بیمارستان های طرح بر روی بیماران بستری شده کووید-19 انجام خواهد گرفت. اسپری بینی حاوی اینترفرون بتا 1 آ توسط شرکت دارویی آماده و در اختیار محققین مطالعه قرار می گیرد. داروها توسط شرکت دارویی در بسته بندی و شکل دارویی کاملا یکسان در اختیار کادر درمانی قرار می گیرد و براساس کدهای رندومیزاسیون که توسط گروه آمار مستقل تهیه شده است، به بیماران اختصاص داده خواهد شد. دستور مصرف: یک اسپری در هر سوراخ بینی روزانه هر 6 ساعت که توسط بیمار صورت میگیرد. طول مدت درمان با اسپری بینی به مدت 7 روز می باشد.
    Patients who have mild to moderate Covid-19 based on the CT-scan data and have no allergic sensitivity to the interferon products or participated in any other trials of Covid-19
    Patients who have Covid-19 based on the CT-scan data or PCR and have no allergic sensitivity to the interferon products or participated in any other trials of Covid-19
    بیماران مبتلا به فرم خفیف تا متوسط کووید-19 بر اساس شواهد CT اسکن که حساسیت به اینترفرون نداشته و در مطالعه دیگر برای کووید-19 شرکت نکرده اند.
    بیماران مبتلا به کووید-19 بر اساس شواهد CT اسکن و یا PCR که حساسیت به اینترفرون نداشته و در مطالعه دیگر برای کووید-19 شرکت نکرده اند.
    Test group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc ..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 14 days. Control (Placebo) Group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc .), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 14 days.
    Test group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc ..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days. Control (Placebo) Group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc .), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days.
    گروه درمانی: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 14 روز و هر شش ساعت یک پاف از اسپری بینی اینترفرون بتا 1آ (ساخت شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد. گروه کنترل (پلاسبو): به همراه رژیم درمانی کشوری (هیدروکسی کلروکین یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 14 روز و هر شش ساعت یک پاف از اسپری بینی پلاسبو (تهیه شده توسط شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد.
    گروه درمانی: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 7 روز و هر شش ساعت یک پاف از اسپری بینی اینترفرون بتا 1آ (ساخت شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد. گروه کنترل (پلاسبو): به همراه رژیم درمانی کشوری (هیدروکسی کلروکین یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 7 روز و هر شش ساعت یک پاف از اسپری بینی پلاسبو (تهیه شده توسط شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد.
    The primary outcome was defined as the Time to Clinical recovery (TTCR), up to 14 days. TTCR is further defined as the time (in hours) from initiation of study treatment (active or placebo) until normalization of fever, and oxygen saturation sustained for at least 72 hours
    The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before Day 7
    هدف اصلی مطالعه به صورت زمان لازم برای بهبود کلینیکال (TTCR) تا 14 روز تعریف شده است. زمان لازم برای بهبود کلینیکال به صورت زمان لازم (ساعت) از شروع درمان (دارو یا پلاسبو) تا زمانی که تب و یا غلظت اشباع اکسیژن به مدت 72 ساعت نرمال شود، تعریف می گردد.
    هدف اصلی مطالعه بررسی کاهش 50 درصدی میزان لود ویروس و یا منفی شدن آن تا قبل روز 7 درمان

  • General information

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    20
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    Year
    Yes
    No
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    65
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    Year
    Yes
    No
    100
    50
    2020-05-21, 1399/03/01
    2020-06-30, 1399/04/10
    empty
    Due to the primary endpoint change, the protocol is updated
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    با توجه به تغییر هدف اولیه، بروز رسانی انجام گردید
    Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in Mild to Moderate cases of Covid-19 at Baqiyatallal Hospital
    Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
    بررسی اثربخشی فرم استنشاقی (اسپری بینی) داروی اینترفرون بتا 1آ در عفونت کووید 19(کرونا ویروس 2019) در بیماران Mild to moderate مراجعه کننده به بیمارستان بقیه الله
    بررسی اثربخشی فرم استنشاقی (اسپری بینی) داروی اینترفرون بتا 1آ در عفونت کووید 19(کرونا ویروس 2019) در بیماران بستری شده در بیمارستان
    Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in Mild to Moderate cases of Covid-19 at Baqiyatallal Hospital
    Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
    بررسی اثربخشی فرم استنشاقی (اسپری بینی) داروی اینترفرون بتا 1آ در عفونت کووید 19(کرونا ویروس 2019) در بیماران Mild to moderate مراجعه کننده به بیمارستان بقیه الله
    بررسی اثربخشی فرم استنشاقی (اسپری بینی) داروی اینترفرون بتا 1آ در عفونت کووید 19(کرونا ویروس 2019) در بیماران بستری شده در بیمارستان
    Patients who have Covid-19 based on the CT-scan findings
    Mild to moderate cases of Covid-19
    Willingness to participate in the study for trial period and signing the informed consent form
    Patients who have Covid-19 based on the CT-scan or RT-PCR findings
    Hospitalized patients
    Willingness to participate in the study for trial period and signing the informed consent form
    Age between 20-65
    بیماران دچار covid-19 بر اساس شواهد CT اسکن
    فرم خفیف یا متوسط بیماری covid-19
    تمایل به شرکت در مطالعه طی مدت زمان مطالعه را داشته باشد و رضایتنامه مطالعه را امضا کند.
    تشخیص بیماری کووید 19 بر اساس وجود علایم مثبت در CT اسکن و یا RT-PCR مثبت
    بیماران نیازمند بستری شدن
    تمایل به شرکت در مطالعه طی مدت زمان مطالعه را داشته باشد و رضایتنامه مطالعه را امضا کند.
    سن بیمار 20-65

  • Primary outcomes

    #1
    The primary outcome was defined as the Time to Clinical recovery (TTCR), up to 14 days. TTCR is further defined as the time (in hours) from initiation of study treatment (active or placebo) until normalization of fever, and oxygen saturation sustained for at least 72 hours
    The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7
    هدف اصلی مطالعه به صورت زمان لازم برای بهبود کلینیکال (TTCR) تا 14 روز تعریف شده است. زمان لازم برای بهبود کلینیکال به صورت زمان لازم (ساعت) از شروع درمان (دارو یا پلاسبو) تا زمانی که تب و یا غلظت اشباع اکسیژن به مدت 72 ساعت نرمال شود، تعریف می گردد.
    هدف اصلی مطالعه بررسی کاهش 50 درصدی میزان لود ویروس و یا منفی شدن آن تا قبل روز 7 درمان
    before drug administration, daily up to day 14
    before drug administration, day 3, day 5, and day 7 (before negative result until day 7)
    در ابتدای مطالعه (قبل شروع مداخله)، روزانه تا روز 14
    در ابتدای مطالعه (قبل شروع مداخله)، روزهای 3 و 5 و 7 (تا قبل منفی شدن تا نهایتا روز 7)
    Thermometer (for fever) and pulse oximeter for oxygen saturation
    RT-PCR test
    ترمومتر برای تب بیمار و پالس اکسی متر برای سطح اکسیژن
    با تست RT-PCR

  • Secondary outcomes

    #1
    Number of days with fever (more than 37.2) up to 14 days
    Number of days with fever (more than 37.2) up to 7 days
    تعداد روزهایی که بیماران تب بالای 37.2 طی 14روز درمان داشته اند
    تعداد روزهایی که بیماران تب بالای 37.2 طی 7 روز درمان داشته اند
    Daily up to day 14
    Daily up to day 7
    روزانه تا روز 14
    روزانه تا روز 7
    #2
    Number of days with dyspnea until day 14
    Number of days with dyspnea until day 7
    تعداد روزهایی که بیماران دچار دیس پنی طی 14 روز درمان شدند
    تعداد روزهایی که بیماران دچار دیس پنی طی 7 روز درمان شدند
    Daily up to day 14
    Daily up to day 7
    روزانه تا روز 14
    روزانه تا روز 7
    #3
    Number of days that patients need mechanical ventilation up to day 14
    Number of days that patients need supplemental oxygenation up to day 7
    تعداد روزهایی که بیماران نیاز به ونتیلاسیون مکانیکی طی 14 روز درمان داشتند
    تعداد روزهایی که بیماران نیاز به supplemental oxygenation طی 7 روز درمان داشتند.
    Daily up to day 14
    Daily up to day 7
    روزانه تا روز 14
    روزانه تا روز 7
    #4
    Number of days that patients need supplemental oxygenation up to day 14
    Change of laboratory results of patients before treatment and last day of study (day 7)
    تعداد روزهایی که بیماران نیاز به supplemental oxygenation طی 14 روز درمان داشتند.
    تغییرات شاخص های آزمایشگاهی طی روز اول قبل تزریق دارو و روز آخر درمان (روز7 درمان)
    Daily up to day 14
    Before drug administration and last day of study
    روزانه تا روز 14
    قبل شروع درمان و روز آخر درمان
    Examination by investigator
    Laboratory results
    بررسی توسط محقق مطالعه
    آزمایشگاه مورد قرارداد
    #5
    Number of hospitalization day
    Adverse events
    تعداد روزهایی که بیمار در بیمارستان بستری بود
    بررسی عوارض جانبی
    Daily up to day 14
    Daily up to day 7
    روزانه تا روز 14
    روزانه تا روز 7
    Recorded checklist by investigator
    Investigator report
    چک لیست ثبت شده توسط محقق مطالعه
    گزارش محقق مطالعه
    #6
    Number of death
    Number of days that patients have dry cough
    تعداد فوت
    تعداد روزهایی که بیماران دچار سرفه خشک طی 7 روز درمان بودند.
    Daily up to day 14
    Daily until day 7
    روزانه تا روز 14
    روزانه تا روز 7
    Investigator report
    Examination by investigator
    گزارش محقق مطالعه
    بررسی توسط محقق مطالعه

  • Intervention groups

    #1
    Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 100 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 14 days
    Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 1000 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
    گروه مداخله: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین و یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 14 روز و هر شش ساعت یک پاف (معادل 100 واحد بین المللی اینترفرون بتا 1 آ) از اسپری بینی اینترفرون بتا 1آ (ساخت شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد
    گروه مداخله: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین و یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 7 روز و هر شش ساعت یک پاف (معادل 1000 واحد بین المللی اینترفرون بتا 1 آ) از اسپری بینی اینترفرون بتا 1آ (ساخت شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد
    #2
    Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 14 days
    Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
    گروه کنترل: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین و یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 14 روز و هر شش ساعت یک پاف از اسپری بینی پلاسبو (تهیه شده توسط شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد
    گروه کنترل: به همراه رژیم درمانی کشوری (هیدروکسی کلروکین و یا هر دارویی که در پروتکل درمانی وزارت بهداشت وجود داشته باشد)، بیماران به مدت 7 روز و هر شش ساعت یک پاف از اسپری بینی پلاسبو (تهیه شده توسط شرکت سیناژن) در هر سوراخ بینی استفاده خواهند کرد

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: CinnaGen company
    Name of organization / entity - Persian: شرکت تحقیقاتی و تولیدی سیناژن
    Full name of responsible person - English: مدیر عامل
    Full name of responsible person - Persian: CEO
    Street address - English: No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
    Street address - Persian: تهران, شهرک غرب، خیابان سیمای ایران، خیابان هفتم، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1467635165
    Phone: +98 26 3667 0334
    Fax:
    Email: cinnagen@cinnagen.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: CinnaGen company
    Name of organization / entity - Persian: شرکت تحقیقاتی و تولیدی سیناژن
    Full name of responsible person - English: Dr. Haleh Hamedifar
    Full name of responsible person - Persian: دکتر هاله حامدی فر
    Street address - English: No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
    Street address - Persian: تهران, شهرک غرب، خیابان سیمای ایران، خیابان هفتم، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1467635165
    Phone: +98 26 3667 0334
    Fax:
    Email: cinnagen@cinnagen.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ashraf Karbasi
    Full name of responsible person - Persian: اشرف کرباسی
    Position - English: Principal investigator
    Position - Persian: محقق اصلی مطالعه
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bagiyatollah University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی بقیه الله
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1435916471
    Phone: +98 21 8126 2040
    Mobile: +98 912 371 9396
    Fax:
    Email: ashraf.karbasi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ashraf Karbasi
    Full name of responsible person - Persian: اشرف کرباسی
    Position - English: Principal investigator
    Position - Persian: محقق اصلی مطالعه
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Baqiyatallah University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی بقیه الله
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1435916471
    Phone: +98 21 8126 2040
    Mobile: +98 912 371 9396
    Fax:
    Email: ashraf.karbasi@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ashraf Karbasi
    Full name of responsible person - Persian: اشرف کرباسی
    Position - English: Principal investigator
    Position - Persian: محقق اصلی مطالعه
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bagiyatollah University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی بقیه الله
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1435916471
    Phone: +98 21 8126 2040
    Mobile: +98 912 371 9396
    Fax:
    Email: ashraf.karbasi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ashraf Karbasi
    Full name of responsible person - Persian: اشرف کرباسی
    Position - English: Principal investigator
    Position - Persian: محقق اصلی مطالعه
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Baqiyatallah University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی بقیه الله
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1435916471
    Phone: +98 21 8126 2040
    Mobile: +98 912 371 9396
    Fax:
    Email: ashraf.karbasi@yahoo.com
    Web page address:

Protocol summary

Study aim
Evaluation of 50% reduction of viral load or negative results of virus before Day 7
Design
A phase III, Placebo-controlled, Paralleled, double-blind, randomized clinical trial
Settings and conduct
This is a randomized double blind study at Baqiyatallal Hospital and other centers of the study at hospitalized covid-19 patients. Nasal spray of interferon beta 1a will be prepared by sponsor of the study (CinnaGen), the package of the test and placebo drug will have totally equal shape and size. The drugs will be coded by randomization code which was prepared by an independent statistical person. The dosage of the drug or placebo: One puff at each nostril, every 6 hours, for 7 days
Participants/Inclusion and exclusion criteria
Patients who have Covid-19 based on the CT-scan data or PCR and have no allergic sensitivity to the interferon products or participated in any other trials of Covid-19
Intervention groups
Test group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc ..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days. Control (Placebo) Group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc .), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days.
Main outcome variables
The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before Day 7

General information

Reason for update
Due to the primary endpoint change, the protocol is updated
Acronym
IRCT registration information
IRCT registration number: IRCT20200511047396N1
Registration date: 2020-05-16, 1399/02/27
Registration timing: prospective

Last update: 2020-06-28, 1399/04/08
Update count: 1
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
Ramin Ajdarzade
Name of organization / entity
CinnaGen
Country
Iran (Islamic Republic of)
Phone
+98 26 3667 0734
Email address
azhdarzadehm@cinnagen.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
Public title
Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have Covid-19 based on the CT-scan or RT-PCR findings Hospitalized patients Willingness to participate in the study for trial period and signing the informed consent form Age between 20-65
Exclusion criteria:
Pregnancy Breastfeeding Use of ARB/ACEi History of hypotension have no consent to participate in the study Allergic sensitivity to the interferon products Not availability of phone number or it is possible to be transferred to other hospitals Having the CKD or patients who need dialysis at the begining of the study Having any disease or condition that based on the physician judgment cannot participate in the study Participation in any other trials of Covid-19
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (block sizes of 4) will be used to allocate drug or placebo to the patients of the study. Test drug or placebo will have randomization code which is specific for each patient and was generated by the randomization process. Randomization will not be exposed to the trial executers and will be provided to the investigator in non-transparent sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Test drug and placebo are totally similar and have same color, shape, and size and is not distinguishable by patients or investigators
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.BMSU.REC.1399.122

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7
Timepoint
before drug administration, day 3, day 5, and day 7 (before negative result until day 7)
Method of measurement
RT-PCR test

Secondary outcomes

1

Description
Number of days with fever (more than 37.2) up to 7 days
Timepoint
Daily up to day 7
Method of measurement
Thermometer

2

Description
Number of days with dyspnea until day 7
Timepoint
Daily up to day 7
Method of measurement
Clinical examination by investigator or history review of the patients

3

Description
Number of days that patients need supplemental oxygenation up to day 7
Timepoint
Daily up to day 7
Method of measurement
Examination by investigator

4

Description
Change of laboratory results of patients before treatment and last day of study (day 7)
Timepoint
Before drug administration and last day of study
Method of measurement
Laboratory results

5

Description
Adverse events
Timepoint
Daily up to day 7
Method of measurement
Investigator report

6

Description
Number of days that patients have dry cough
Timepoint
Daily until day 7
Method of measurement
Examination by investigator

Intervention groups

1

Description
Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 1000 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
Category
Treatment - Drugs

2

Description
Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallal Hospital
Full name of responsible person
Ashraf Karbasi
Street address
Baqiyatallal Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 2037
Email
ashraf.karbasi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CinnaGen company
Full name of responsible person
Dr. Haleh Hamedifar
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1467635165
Phone
+98 26 3667 0334
Email
cinnagen@cinnagen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen company
Proportion provided by this source
100
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ashraf Karbasi
Position
Principal investigator
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 2040
Email
ashraf.karbasi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ashraf Karbasi
Position
Principal Investigator
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallal Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 2040
Email
ashraf.karbasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ashraf Karbasi
Position
Principal investigator
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 2040
Email
ashraf.karbasi@yahoo.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
Not applicable
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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