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Comparison of vitamin D3 and N-acetylcysteine prescription in COVID19 patients and their effect on recovery process

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History
# Registration date Revision Id
2 2020-05-30, 1399/03/10 137270
1 2020-03-29, 1399/01/10 127244
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  • Protocol summary

    A randomised factorial trial with single blinded outcome assessment
    This study will be conducted on randomized, double-blind, phase 3 clinical trials in 100 patients. Randomization method is block randomization and block size was 8 and 4.
    این مطالعه کارآزمایی بالینی تصادفی،فاکتوریال و یک سو کور می باشد
    این مطالعه کارآزمایی بالینی تصادفی شده، دوسویه کور، فاز 3 بر روی 100 بیمار انجام خواهد شد . تصادفی سازی از نوع تصادفی سازی بلوکی با بلوک های هشت تایی و چهار تایی می باشد.
    A randomised factorial trial with single blinded study was performed at Ayatollah Taleghani Hospital in Abadan This study was conducted on 100 patients with COVID-19 admitted to the infectious ward of Ayatollah Taleghani Hospital. Written consent was obtained for this study.
    This randomized, double-blind clinical trial is being conducted at Ayatollah Taleghani Hospital in Abadan. The study was performed on 100 patients with COVID-19 who were admitted to the infectious disease ward of Ayatollah Taleghani Hospital. A written consent was obtained for this study. In this study participants, researchers and outcome assessment are blind.
    این مطالعه کارآزمایی بالینی تصادفی،فاکتوریال و یک سو کور می باشد در بیمارستان آیت الله طالقانی آبادان انجام می شود. این مطالعه روی ۱۰۰ بیمار مبتلا به COVID-19 که در بخش عفونی بیمارستان آیت الله طالقانی بستری شدند، انجام می شود. برای انجام این مطالعه رضایت نامه کتبی اخذ گردید.
    این مطالعه کارآزمایی بالینی تصادفی، دو سویه کور می باشد در بیمارستان آیت الله طالقانی آبادان انجام می شود. این مطالعه روی ۱۰۰ بیمار مبتلا به COVID-19 که در بخش عفونی بیمارستان آیت الله طالقانی بستری شدند، انجام می شود. برای انجام این مطالعه رضایت نامه کتبی اخذ گردید. در این مطالعه شرکت کنندگان، محقق و ارزیابی کننده پیامد کور می باشند.
    Inclusion criteria: positive COVID-19 with severe symptoms Exclusion criteria: Take a drug other than the medication mentioned
    Inclusion criteria: COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan for COVID-19. Exclusion criteria: Pregnant or breast feeding women, Patients under 18 years of age, Any life-threatening factor
    بیماران کرونا مثبت با علائم شدید معیار خروج: دریافت دارویی غیر از رژیم دارویی ذکر شده
    معیار ورود : بیماران مبتلا به کووید 19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت برای COVID-19 دارند. معیار خروج: زنان باردار و شیرده ، بیماران زیر ۱۸ سال، هر گونه عامل تهدید کننده حیات
    The first group only receiving Standard protocol national drugs The second group receiving Standard protocol national drugs plus vitamin D3 50,000 units once a week. The third group receiving Standard protocol national drugs plus 600mg daily N acetylcysteine. The fourth group receiving Standard protocol national drugs drugs with a 500,000 unit dose of vitamin D3 once a week with 600mg N acetylcysteine daily.
    Note: standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours + hydroxychloroquine (200 mg) two tablets one dose). The first group: Patients receiving standard country protocol drugs with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours The second group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week The third group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week The fourth group: Patients receiving standard country protocol drugs with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours
    گروه اول بیماران فقط مصرف کننده داروهای استاندارد پروتکل کشوری گروه دوم بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه قرص ویتامین D3 50000 واحدی یکبار در هفته گروه سوم بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه قرص N استیل سیستئین 600mg روزانه گروه چهارم بیماران دریافت کننده داروهای استاندارد پروتکل کشوری با قرص ویتامین D3 50000واحدی یکبار در هفته به همراه قرص N استیل سیستئین 600mg روزانه
    هر چهار گروه مداخله داروهای استاندارد پروتکل کشوری که عبارت است از (قرص(لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز) را دریافت می کنند. -گروه اول: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه آمپول ویتامین D3 50000 واحدی یکبار در هفته و قرص پلاسبوی N استیل سیستئین هر 12 ساعت -گروه دوم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه قرص N استیل سیستئین 600mg هر 12 ساعت و آمپول پلاسبوی ویتامین D3 یکبار در هفته -گروه سوم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه قرص N استیل سیستئین 600mg هر 12 ساعت و آمپول ویتامین D3 50000 واحدی یکبار در هفته -گروه چهارم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری به همراه قرص پلاسبوی ویتامین D3 یکبار در هفته و قرص پلاسبوی N استیل سیستئین هر 12 ساعت
    changes in level of consciousness, breathing rate, arterial oxygen saturation and changes in laboratory factors, gastrointestinal disorder, number of days of hospitalization and mortality.
    Time to clinical improvement defined as start of taking medication time to Discharge Time.
    تغییرات سطح هوشیاری ، تعداد تنفس ، میزان اشباع اکسیژن خون شریانی و تغییرات فاکتورهای آزمایشگاهی ، اختلالات گوارشی ، تعداد روزهای بستری و میزان مرگ و میر
    زمان بهبود علائم بالینی که از زمان شروع مصرف دارو تا زمان ترخیص در نظر گرفته می شود.

  • General information

    empty
    18
    empty
    Year
    Yes
    No
    Single blinded
    Double blinded
    1
    1
    1
    1
    Not used
    Used
    Yes
    No
    1
    empty
    2020-03-29, 1399/01/10
    2020-06-06, 1399/03/17
    2020-05-21, 1399/03/01
    2020-07-07, 1399/04/17
    empty
    Update patient history and edit data list editing
    empty
    بروزرسانی تاریخ بیمارگیری و ویرایش لیست انتشار داده ها
    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 for COVID-19.
    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 بینیتایید ابتلا به covid19 توسط پزشک متخصص عفونیداشتن رضایت به شرکت در مداخله
    بیماران مبتلا به کووید 19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا CT Scan مثبت برای COVID-19 دارند.
    Pregnant and lactating womenThose taking losartan and captopril.Those with a history of intestinal ulcers or gastrointestinal bleeding
    Pregnant or breast feeding women
    Patients under 18 years of age
    Any life-threatening factor
    زنان باردار و شیرده کسانی که لوزاراتان و کپتوپریل مصرف می کنند.کسانی که سابقه زخم روده یا خونریزی گوارشی دارند.
    زنان باردار و شیرده
    بیماران زیر ۱۸ سال
    هر گونه عامل تهدید کننده حیات
    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.
    This study will be a randomized, double-blind, phase 3 clinical trials on 100 patients. Randomization method is block randomization and block size was 8 and 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website. Sealed envelopes were used for allocation concealment.
    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.
    این مطالعه یک کارآزمایی بالینی تصادفی ، دو سو کور ، فاز 3 بر روی 100 بیمار خواهد بود. تصادفی سازی از نوع تصادفی سازی بلوکی که با استفاده از بلوک های هشت تایی و چهار تایی انجام شد. زنجیره تصادفی و کد های concealment توسط وبسایت www.sealedenvelope.com تولید می شود. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
    The participants in this study are blind and the drug used in both groups is similar in appearance. So patients do not understand which group they are in.
    . In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.
    شرکت کنندگان در این مطالعه کور می باشد و داروی مورد استفاده در هر دوگروه قرص می باشد که از نظر شکل ظاهری مشابه می باشند. بنابراین بیماران متوجه نمی شوند که در کدام گروه قرار دارند.
    رضایت کتبی برای این مطالعه به دست آمد. شرکت کنندگان، محقق، مراقب بالینی، آنالیز کننده داده و ارزیابی کننده پیامد در این مطالعه کور می باشند. داروی مورد استفاده از نظر شکل ظاهری مشابه می باشند، بنابراین بیماران متوجه نمی شوند که در کدام گروه قرار دارند. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
    Appropriate specimens are generally collected from the respiratory tract
    empty
    نمونه مناسب عموما از ناحیه تنفسی جمع وری میشود
    empty

  • Primary outcomes

    #1
    Shortness of breath
    Time to clinical improvement defined as start of taking medication time to Discharge Time.
    تنگی نفس
    زمان بهبود علائم بالینی که از زمان شروع مصرف دارو تا زمان ترخیص در نظر گرفته می شود.
    Time to get the Corona test positive _14 days after test positive
    The beginning of the study ,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
    Using oral thermometer and Improve symptoms
    Medical record
    با استفاده از دماسنج دهانی و بهبود علایم بیماری
    پرونده بیمار
    #2
    Cough
    empty
    سرفه
    empty
    Time to get the Corona test positive _14 days after test
    empty
    زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
    empty
    Clinical observation and examination
    empty
    مشاهده و معاینه بالینی
    empty
    #3
    Chills
    empty
    لرز
    empty
    Time to get the Corona test positive _14 days after test positive
    empty
    زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
    empty
    Clinical observation and examination
    empty
    مشاهده و معاینه بالینی
    empty
    #4
    Night sweats
    empty
    تعریق شبانه
    empty
    Time to get the Corona test positive _14 days after test positive
    empty
    زمان مثبت شدن تست کرونا- 14 روز بعد از زمان مثبت شدن تست
    empty
    Clinical observation and examination
    empty
    مشاهده و معاینه بالینی
    empty

  • Secondary outcomes

    #1
    empty
    Complete Blood Count
    empty
    Complete Blood Count
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    blood sample
    empty
    نمونه خون
    #2
    empty
    Venous blood gas
    empty
    Venous blood gas
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #3
    empty
    C-reactive-protein
    empty
    C-reactive-protein
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #4
    empty
    creatinne
    empty
    creatinne
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #5
    empty
    Aspartate amino transferase
    empty
    Aspartate amino transferase
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #6
    empty
    Alanine amino transferase
    empty
    Alanine amino transferase
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #7
    empty
    Prothrombin time
    empty
    Prothrombin time
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #8
    empty
    Partial Thromboplastin time
    empty
    Partial Thromboplastin time
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Blood sample
    empty
    نمونه خون
    #9
    empty
    Cough
    empty
    سرفه
    empty
    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
    empty
    Clinical observation and examination
    empty
    مشاهده و معاینه بالینی
    #10
    empty
    level of consciousness
    empty
    سطح هوشیاری
    empty
    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
    empty
    Using the Glasgow Coma scale
    empty
    استفاده از معیار کمای گلاسکو
    #11
    empty
    shortness of breath
    empty
    تنگی نفس
    empty
    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
    empty
    Clinical observation and examination
    empty
    مشاهده و معاینه بالینی
    #12
    empty
    Fatigue
    empty
    خستگی
    empty
    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
    empty
    Observation and Interview with the patient
    empty
    مشاهده و مصاحبه با بیمار
    #13
    empty
    Severe and frequent diarrhea
    empty
    اسهال شدید و مکرر
    empty
    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
    empty
    Interview with the patient
    empty
    مصاحبه با بیمار
    #14
    empty
    abdominal pain
    empty
    شکم درد
    empty
    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
    empty
    Interview with the patient
    empty
    مصاحبه با بیمار
    #15
    empty
    nausea and vomiting
    empty
    تهوع و استفراغ
    empty
    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
    empty
    Interview with the patient
    empty
    مصاحبه با بیمار
    #16
    empty
    Olfactory disturbances
    empty
    اختلال حس بویایی
    empty
    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
    empty
    Interview with the patient
    empty
    مصاحبه با بیمار
    #17
    empty
    Appetite
    empty
    اشتها
    empty
    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
    empty
    Observation and Interview with the patient
    empty
    مشاهده و مصاحبه با بیمار
    #18
    empty
    Duration of ICU stay
    empty
    مدت زمان بستری در ICU
    empty
    Daily
    empty
    روزانه
    empty
    Number of days of hospitalization in ICU
    empty
    شمارش روزهای بستری در ICU
    #19
    empty
    Adverse events
    empty
    عوارض جانبی
    empty
    Time of discharge
    empty
    زمان ترخیص
    empty
    Medical record
    empty
    پرونده بیمار
    #20
    empty
    The patient's condition is based on inpatient or outpatient
    empty
    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
    empty
    ابتدای مطالعه، روز 7 ، روز 14 ، روز 21 و روز 28
    empty
    seven category ordinal scale
    empty
    مقیاس ترتیبی هفت طبقه
    #21
    empty
    Mortality rate
    empty
    میزان مرگ و میر
    empty
    Daily
    empty
    روزانه
    empty
    Medical record
    empty
    پرونده بیمار
    #22
    empty
    Taste disturbances
    empty
    اختلال حس چشایی
    empty
    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
    empty
    Interview with the patient
    empty
    مصاحبه با بیمار

  • Intervention groups

    #1
    Group I: Receivers of standard national protocol drugs
    Intervention group 1: Patients receiving standard country protocol drugs(lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours
    گروه اول : دریافت کننده داروهای استاندارد پروتکل کشوری
    گروه اول : بیماران دریافت کننده داروهای استاندارد پروتکل کشوری (لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز) به همراه آمپول ویتامین D3 50000 واحدی یکبار در هفته و قرص پلاسبوی N استیل سیستئین هر 12 ساعت
    #2
    Intervention group: Group II: Drug recipients of National Medicines Standard Protocol + (Perl Vitamin D3 50,000 units) once a week
    Intervention group 2: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week
    گروه دریافت کننده داروهای داروهای استاندارد پروتکل کشوری + (ویتامین D3 پرل 50000 واحد) یکبار در هفته
    گروه دوم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری(لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز) به همراه قرص N استیل سیستئین 600mg هر 12 ساعت و آمپول پلاسبوی ویتامین D3 یکبار در هفته
    #3
    Intervention group: Group III: National standard drug + N acetylcysteine (NAC) tablets receiving 600mg every 12 hours for 14 days
    Intervention group 3: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week
    گروه مداخله: گروه سوم: دریافت کننده داروهای داروهای استاندارد پروتکل کشوری + قرص N استیل سیستئین NAC) 600mg) هر 12 ساعت یک عدد به مدت 14 روزگروه
    گروه سوم : گروه سوم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری(لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز) به همراه قرص N استیل سیستئین 600mg هر 12 ساعت و آمپول ویتامین D3 50000 واحدی یکبار در هفته
    #4
    Intervention group: Group IV: National standard protocol drug + (Perl vitamin D3 50,000 units) once a week + N acetylcysteine (NAC) tablet 600mg every 12 hours for 14 days
    Intervention group 4: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours
    گروه مداخله: گروه چهارم: دریافت کننده داروهای داروهای استاندارد پروتکل کشوری + (ویتامین D3 پرل 50000 واحد) یکبار در هفته + قرص N استیل سیستئین (NAC) 600mgهر 12 ساعت یک عدد به مدت 14 روز
    گروه چهارم: بیماران دریافت کننده داروهای استاندارد پروتکل کشوری (لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز) به همراه قرص پلاسبوی ویتامین D3 یکبار در هفته و قرص پلاسبوی N استیل سیستئین هر 12 ساعت

  • Sharing plan

    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    I haven't decided yet - its release schedule is still unclear
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
    empty
    empty
    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.
    empty
    The data access period after printing the article
    empty
    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.
    empty
    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.
    empty
    انجام هر گونه آنالیز با رضایت محقق اصلی میتواند انجام شود.
    empty
    s.mobarak@abadanums.ac.ir
    empty
    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.
    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.

Protocol summary

Study aim
Comparison of the administration of vitamin D3 and N acetylcysteine tablets in COVID-19 patients and their effect on recovery
Design
This study will be conducted on randomized, double-blind, phase 3 clinical trials in 100 patients. Randomization method is block randomization and block size was 8 and 4.
Settings and conduct
This randomized, double-blind clinical trial is being conducted at Ayatollah Taleghani Hospital in Abadan. The study was performed on 100 patients with COVID-19 who were admitted to the infectious disease ward of Ayatollah Taleghani Hospital. A written consent was obtained for this study. In this study participants, researchers and outcome assessment are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan for COVID-19. Exclusion criteria: Pregnant or breast feeding women, Patients under 18 years of age, Any life-threatening factor
Intervention groups
Note: standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours + hydroxychloroquine (200 mg) two tablets one dose). The first group: Patients receiving standard country protocol drugs with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours The second group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week The third group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week The fourth group: Patients receiving standard country protocol drugs with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours
Main outcome variables
Time to clinical improvement defined as start of taking medication time to Discharge Time.

General information

Reason for update
Update patient history and edit data list editing
Acronym
IRCT registration information
IRCT registration number: IRCT20200324046850N1
Registration date: 2020-03-29, 1399/01/10
Registration timing: prospective

Last update: 2020-06-03, 1399/03/14
Update count: 1
Registration date
2020-03-29, 1399/01/10
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
2020-06-06, 1399/03/17
Expected recruitment end date
2020-07-07, 1399/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin D3 and N-acetylcysteine prescription in COVID19 patients and their effect on recovery process
Public title
Comparison of vitamin D3 and N-acetylcysteine prescription in COVID-19 patients and their effect on recovery process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan for COVID-19.
Exclusion criteria:
Pregnant or breast feeding women Patients under 18 years of age Any life-threatening factor
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a randomized, double-blind, phase 3 clinical trials on 100 patients. Randomization method is block randomization and block size was 8 and 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website. Sealed envelopes were used for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
. In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.
Placebo
Used
Assignment
Factorial
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 061
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.ABADANUMS.REC.1398.118

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Time to clinical improvement defined as start of taking medication time to Discharge Time.
Timepoint
The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Medical record

Secondary outcomes

1

Description
Complete Blood Count
Timepoint
The beginning of the study and the time of discharge
Method of measurement
blood sample

2

Description
Venous blood gas
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

3

Description
C-reactive-protein
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

4

Description
creatinne
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

5

Description
Aspartate amino transferase
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

6

Description
Alanine amino transferase
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

7

Description
Prothrombin time
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

8

Description
Partial Thromboplastin time
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample

9

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

10

Description
level of consciousness
Timepoint
The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Using the Glasgow Coma scale

11

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

12

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
Observation and Interview with the patient

13

Description
Severe and frequent 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

14

Description
abdominal 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

15

Description
nausea and vomiting
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

16

Description
Olfactory disturbances
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

17

Description
Appetite
Timepoint
The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Observation and Interview with the patient

18

Description
Duration of ICU stay
Timepoint
Daily
Method of measurement
Number of days of hospitalization in ICU

19

Description
Adverse events
Timepoint
Time of discharge
Method of measurement
Medical record

20

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

21

Description
Mortality rate
Timepoint
Daily
Method of measurement
Medical record

22

Description
Taste disturbances
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

Intervention groups

1

Description
Intervention group 1: Patients receiving standard country protocol drugs(lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week
Category
Treatment - Drugs

3

Description
Intervention group 3: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week
Category
Treatment - Drugs

4

Description
Intervention group 4: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours
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 5326 7800
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?
No
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
6313833177
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.
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