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Protocol summary
concealed, randomized, single blinded, phase 2 controlled clinical trial with two arm parallel group design of 20 patients, using the placebo in the control group.
Concealed, randomized, single blinded, phase 2 controlled clinical trial with two arm parallel group design of 20 patients, using the placebo in the control group.
concealedConcealed, randomized, single blinded, phase 2 controlled clinical trial with two arm parallel group design of 20 patients, using the placebo in the control group.
General information
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Due to the decrease in the number of COVID-19 patients referring to our center and the results of studies that show a non-significant effect of sex factor on the severity of COVID-19, random allocation of patients have not been stratified according to gender.
Due to the prevention of possible drug side effects, the dose of the intervention drug was reduced from 5 times a day to 3 times a day.
The placebo dose was also reduced by the same amount.
Due to the decrease in the number of COVID-19 patients referring to our center and the results of studies that show a non-significant effect of sex factor on the severity of COVID-19, random allocation of patients have not been stratified according to gender. Due to the prevention of possible drug side effects, the dose of the intervention drug was reduced from 5 times a day to 3 times a day. The placebo dose was also reduced by the same amount.
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با توجه به کاهش بیماران COVID-19 مراجعه کننده به مرکز ما و نتایج مطالعاتی که نشان دهنده تأثیر غیر معنادار عامل جنسیت بر شدت بیماری COVID-19 می باشند ، تخصیص تصادفی بیماران براساس جنسیت طبقه بندی نشده است.
به دلیل جلوگیری از عوارض احتمالی دارویی، دوز مصرفی داروی مداخله از 5 بار در روز به 3 بار در روز تقلیل یافت.
همچنین دوز مصرف دارونما نیز به همین میزان کاهش یافت.
با توجه به کاهش بیماران COVID-19 مراجعه کننده به مرکز ما و نتایج مطالعاتی که نشان دهنده تأثیر غیر معنادار عامل جنسیت بر شدت بیماری COVID-19 می باشند ، تخصیص تصادفی بیماران براساس جنسیت طبقه بندی نشده است. به دلیل جلوگیری از عوارض احتمالی دارویی، دوز مصرفی داروی مداخله از 5 بار در روز به 3 بار در روز تقلیل یافت. همچنین دوز مصرف دارونما نیز به همین میزان کاهش یافت.
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals.
the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method.
Individualized random allocation is done in blocks with sizes 2 and 4, and with stratification based on gender.
eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions.
(randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals.
the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method.
Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification.
eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions.
(randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and withwithout stratification based on gender. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
قبل از تخصیص گروه ها به افراد واجد شرایط شرکت در مطالعه، رضایت نامه آگاهانه جهت گروه بندی افراد تکمیل می گردد.
توالی تصادفی با استفاده از ابزار های آنلاین (https://www.sealedenvelope.com/) و با روش تصادفی سازی بلوک توسط فردی که در بیمار گیری و تخصیص افراد به کد های تصادفی نقشی ندارد تهیه می شود.
تخصیص تصادفی فردی در بلوک های 2 و 4 تایی و با لایه بندی بر اساس جنسیت صورت می گیرد. شرایط ورود به مطالعه توسط مسئول بیمار گیری مطالعه کنترل می شود.
کد های موجود در توالی تصادفی توسط تیم درمانی بدون اطلاع از اینکه هر کد در گروه مداخله یا دارونما قرار دارد به بیماران اختصاص داده می شود. سپس کد های بیماران برای انجام مداخلات با اطلاعات توالی تصادفی تولید شده مطابقت داده می شوند. (پنهان سازی تخصیص تصادفی توسط تیم درمان و بدون اطلاع مسئول بیمارگیری و فردی که توالی تصادفی را تهیه کرده است صورت می گیرد.)
قبل از تخصیص گروه ها به افراد واجد شرایط شرکت در مطالعه، رضایت نامه آگاهانه جهت گروه بندی افراد تکمیل می گردد.
توالی تصادفی با استفاده از ابزار های آنلاین (https://www.sealedenvelope.com/) و با روش تصادفی سازی بلوک توسط فردی که در بیمار گیری و تخصیص افراد به کد های تصادفی نقشی ندارد تهیه می شود.
تخصیص تصادفی فردی در بلوک های 2 و 4 تایی و بدون لایه بندی صورت می گیرد. شرایط ورود به مطالعه توسط مسئول بیمار گیری مطالعه کنترل می شود.
کد های موجود در توالی تصادفی توسط تیم درمانی بدون اطلاع از اینکه هر کد در گروه مداخله یا دارونما قرار دارد به بیماران اختصاص داده می شود. سپس کد های بیماران برای انجام مداخلات با اطلاعات توالی تصادفی تولید شده مطابقت داده می شوند. (پنهان سازی تخصیص تصادفی توسط تیم درمان و بدون اطلاع مسئول بیمارگیری و فردی که توالی تصادفی را تهیه کرده است صورت می گیرد.)
قبل از تخصیص گروه ها به افراد واجد شرایط شرکت در مطالعه، رضایت نامه آگاهانه جهت گروه بندی افراد تکمیل می گردد. توالی تصادفی با استفاده از ابزار های آنلاین (https://www.sealedenvelope.com/) و با روش تصادفی سازی بلوک توسط فردی که در بیمار گیری و تخصیص افراد به کد های تصادفی نقشی ندارد تهیه می شود. تخصیص تصادفی فردی در بلوک های 2 و 4 تایی و بابدون لایه بندی بر اساس جنسیت صورت می گیرد. شرایط ورود به مطالعه توسط مسئول بیمار گیری مطالعه کنترل می شود. کد های موجود در توالی تصادفی توسط تیم درمانی بدون اطلاع از اینکه هر کد در گروه مداخله یا دارونما قرار دارد به بیماران اختصاص داده می شود. سپس کد های بیماران برای انجام مداخلات با اطلاعات توالی تصادفی تولید شده مطابقت داده می شوند. (پنهان سازی تخصیص تصادفی توسط تیم درمان و بدون اطلاع مسئول بیمارگیری و فردی که توالی تصادفی را تهیه کرده است صورت می گیرد.)
Primary outcomes
#1
Pulse oximeter
Pulse Oximeter
Pulse oximeterOximeter
#2
Pulse oximeter
Pulse Oximeter
Pulse oximeterOximeter
#3
chest x-ray
Chest X-ray
chest xChest X-ray
#4
pathobiology laboratory
Pathobiology laboratory
pathobiologyPathobiology laboratory
#5
pathobiology laboratory
Pathobiology laboratory
pathobiologyPathobiology laboratory
#6
pathobiology laboratory
Pathobiology laboratory
pathobiologyPathobiology laboratory
Intervention groups
#1
Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection five times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician:• Caltrate tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days• Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days
Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection three times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection fivethree times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician:• Caltrate kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days• Tablets (. Atazanavir / Ritonavir tablets (300mg/100mg) 300/100, One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
گروه مداخله: گروه A.: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و اریتروپویتین نوترکیب (اپرکس، تولید شرکت دارویی جنسون و جنسون) 300 unit/Kg یا معادل 4000IU را به صورت تزریق زیر جلدی پنج بار در روز، روزانه به مدت 5 روز دریافت می کنند و همزمان نیز Enoxaparin 1mg/kg SQ daily جهت جلوگیری از ترومبوز دریافت میکنند فشارخون بیماران نیز به همراه سایر علایم حیاتی با فواصل منظم و به صورت مکرر چک میشود.از بیماران نیز رضایت نامه اگاهانه جهت دریافت دارو گرفته میشود و کلیه نکات مثبت و منفی مصرف دارو توضیح داده میشود. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات:• قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روزیکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج:• قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز• قرص (آتازاناویر/ریتوناویر) 300/100 یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز] می باشد.
گروه مداخله: گروه A.: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و اریتروپویتین نوترکیب (اپرکس، تولید شرکت دارویی جنسون و جنسون) 300 unit/Kg یا معادل 4000IU را به صورت تزریق زیر جلدی سه بار در روز، روزانه به مدت 5 روز دریافت می کنند و همزمان نیز Enoxaparin 1mg/kg SQ daily جهت جلوگیری از ترومبوز دریافت میکنند فشارخون بیماران نیز به همراه سایر علایم حیاتی با فواصل منظم و به صورت مکرر چک میشود.از بیماران نیز رضایت نامه اگاهانه جهت دریافت دارو گرفته میشود و کلیه نکات مثبت و منفی مصرف دارو توضیح داده میشود. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات: قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روز. یکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج: قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز. قرص آتازاناویر/ریتوناویر (mg300/100mg) ،یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز می باشد.
گروه مداخله: گروه A.: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و اریتروپویتین نوترکیب (اپرکس، تولید شرکت دارویی جنسون و جنسون) 300 unit/Kg یا معادل 4000IU را به صورت تزریق زیر جلدی پنجسه بار در روز، روزانه به مدت 5 روز دریافت می کنند و همزمان نیز Enoxaparin 1mg/kg SQ daily جهت جلوگیری از ترومبوز دریافت میکنند فشارخون بیماران نیز به همراه سایر علایم حیاتی با فواصل منظم و به صورت مکرر چک میشود.از بیماران نیز رضایت نامه اگاهانه جهت دریافت دارو گرفته میشود و کلیه نکات مثبت و منفی مصرف دارو توضیح داده میشود. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات:• قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روزیکیروز. یکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج:• قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز• . قرص (آتازاناویر/ریتوناویر (mg300/100mg) 300/100 ،یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز] می باشد.
#2
Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection five times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician:• Caltrate tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days• Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days
Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection three times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection fivethree times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician:• Caltrate kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days• Tablets (. Atazanavir / Ritonavir tablets (300mg/100mg) 300/100, One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
گروه کنترل: گروه B: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و دارونما (آب مقطر) را به صورت تزریق زیر جلدی پنج بار در روز، روزانه به مدت 5 روز دریافت می کنند. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات:• قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روزیکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج:• قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز• قرص (آتازاناویر/ریتوناویر) 300/100 یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز] می باشد.
گروه کنترل: گروه B: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و دارونما (آب مقطر) را به صورت تزریق زیر جلدی سه بار در روز، روزانه به مدت 5 روز دریافت می کنند. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات: قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روز. یکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج: قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز. قرص آتازاناویر/ریتوناویر (mg300/100mg) ،یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز می باشد.
گروه کنترل: گروه B: درمان دارویی استاندارد را بر اساس پروتکل های درمانی کمیته ملی COVID-19 و دارونما (آب مقطر) را به صورت تزریق زیر جلدی پنجسه بار در روز، روزانه به مدت 5 روز دریافت می کنند. درمان دارویی استاندارد طبق پروتکل های درمان کمیته ملی COVID-19 شامل:هیدروکسی کلروکین/کلروکین فسفات:• قرص هیدروکسی کلروکین سولفات 200 میلی گرم یا قرص کلروکین فسفات 250 میلی گرم (معادل 150 میلی گرم مقدار پایه) روز اول هر 12 ساعت 2 قرص و در ادامه هر 12 ساعت یک قرص بمدت حداقل 7 روز و حداکثر تا 14 روزیکیروز. یکی از دارو های زیر به صلاحدید و تشخیص پزشک معالج:• قرص کلترا (لوپیناویر/ریتوناویر) 200/50 میلی گرم هر 12 ساعت 2 عدد بعد از غذا حداقل 7 روزو حداکثر 14 روز• . قرص (آتازاناویر/ریتوناویر (mg300/100mg) 300/100 ،یک قرص روزانه همراه غذا یا آتازاناویر 400 میلی گرم روزانه حداقل 7 روز و حداکثر 14 روز] می باشد.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر تیمور آقاملایی
Full name of responsible person - Persian: Dr. Teamur Aghamolaei
Street address - English: Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
Street address - Persian: ایران، هرمزگان، بندرعباس، بلوار شهید چمران، دانشگاه علوم پزشکی هرمزگان، معاونت تحقیقات و فناوری
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7916613885
Phone: +98 76 3333 7192
Fax: +98 76 3333 7192
Email: research@hums.ac.ir
Web page address: https://resv.hums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Teamur Aghamolaei
Full name of responsible person - Persian: دکتر تیمور آقاملایی
Street address - English: Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
Street address - Persian: ایران، هرمزگان، بندرعباس، بلوار شهید چمران، دانشگاه علوم پزشکی هرمزگان، معاونت تحقیقات و فناوری
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7916613885
Phone: +98 76 3333 7192
Fax: +98 76 3333 7192
Email: research@hums.ac.ir
Web page address: https://resv.hums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر تیمور آقاملاییDr. Teamur Aghamolaei Full name of responsible person - Persian: Dr. Teamur Aghamolaeiدکتر تیمور آقاملایی Street address - English: Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran Street address - Persian: ایران، هرمزگان، بندرعباس، بلوار شهید چمران، دانشگاه علوم پزشکی هرمزگان، معاونت تحقیقات و فناوری City - English: Bandar Abbas City - Persian: بندرعباس Province: Hormozgan Country: Iran (Islamic Republic of) Postal code: 7916613885 Phone: +98 76 3333 7192 Fax: +98 76 3333 7192 Email: research@hums.ac.ir Web page address: https://resv.hums.ac.ir/
Protocol summary
Study aim
This study aims to investigate the effect of recombinant erythropoietin on the recovery process of COVID-19 patients.
Design
Concealed, randomized, single blinded, phase 2 controlled clinical trial with two arm parallel group design of 20 patients, using the placebo in the control group.
Settings and conduct
This study will be performed at Shahid Mohammadi Hospital in Bandar Abbas. Patients enter the study after obtaining written consent, but will not know which group they belong to.
Participants/Inclusion and exclusion criteria
All positive COVID-19 patients who have Hb≤9 and at least one of the severe COVID-19 symptoms and are willing to cooperate in this project will be included in the study.
Patients with a history of coronary heart disease, thrombosis, deep vein thrombosis, chronic lung disease, diabetes mellitus, weakened immune system, end stage renal disease, liver disease, and patients with a history of taking oral contraceptive pills, systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 90 mm Hg and age over 65 and erythropoietin above 500 are excluded.
Intervention groups
Patients are divided into two groups. In group A, the standard treatment for COVID-19 patients with recombinant erythropoietin is prescribed. In group B, patients receive standard COVID-19 treatment with the placebo.
Main outcome variables
Patient clinical symptoms,
Laboratory examinations of patients and
Hemoglobin
General information
Reason for update
Due to the decrease in the number of COVID-19 patients referring to our center and the results of studies that show a non-significant effect of sex factor on the severity of COVID-19, random allocation of patients have not been stratified according to gender.
Due to the prevention of possible drug side effects, the dose of the intervention drug was reduced from 5 times a day to 3 times a day.
The placebo dose was also reduced by the same amount.
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047364N1
Registration date:2020-08-09, 1399/05/19
Registration timing:registered_while_recruiting
Last update:2020-08-17, 1399/05/27
Update count:2
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Dariush Hooshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3670 3778
Email address
dariush.hooshyar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of recombinant erythropoietin on the improvement of COVID-19 patients
Public title
Effect of erythropoietin on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All definitively positive COVID-19 patients with Hb≤9.
Having at least one of the severe symptoms of COVID-19, including tachypnea (breathing rate> 30 beats per minute), hypoxemia (O2 ≤93 saturation, the partial pressure ratio of arterial oxygen <300), Lung infiltration (> 50% of lung field within 24 to 48 hours), progressive lymphopenia, LDH>245 U/I, CRP>100
Exclusion criteria:
Patients with a history of coagulopathy
Patients with a history of thrombosis
Patients with a history of deep vein thrombosis
Patients with a history of chronic lung disease
Patients with a history of diabetes mellitus
Patients with weakened immune systems
Patients with a history of end stage renal disease
Patients with liver disease
Patients with a history of taking oral contraceptive pills (OCPs)
Patients with systolic blood pressure greater than 160 mmHg
Patients with diastolic blood pressure greater than 90 mmHg
Patients over 65 years of age
Patients with erythropoietin above 500
Patients with a history of myocardial infarction or unstable angina
Patients with a history of malignancy
Age
To 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals.
the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method.
Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification.
eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions.
(randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all participants are aware of participating in this study and enter the study with their consent. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive recombinant erythropoietin in the treatment group and receive a placebo in the control group.
The lead researcher, health care personnel, data collection officials, and those who evaluate the outcome are aware of the grouping of patients.
Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
bandar abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.HUMS.REC.1399.165
Health conditions studied
1
Description of health condition studied
Laboratory confirmed COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Respiratory rate
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pulse Oximeter
2
Description
Oxygen saturation state and arterial oxygen partial pressure ratio
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pulse Oximeter
3
Description
Lung infiltration status
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Chest X-ray
4
Description
LDH level's
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory
5
Description
CRP level's
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory
6
Description
Lymphocyte count
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory
7
Description
Endogenous erythropoietin level's
Timepoint
Beginning of study (before intervention)
Method of measurement
Pathobiology laboratory
8
Description
Patients' blood pressure
Timepoint
At the beginning of the study (before the intervention), during the intervention (5-day erythropoietin administration)
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
Patients' blood hemoglobin levels
Timepoint
Start of study (before the intervention), day 5 after the intervention and 2 to 4 weeks after the intervention
Method of measurement
Pathobiology laboratory
Intervention groups
1
Description
Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection three times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Category
Treatment - Drugs
2
Description
Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection three times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr. Mehdi Hassaniazad
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teamur Aghamolaei
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dariush Hooshyar
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 990 038 7226
Email
dariush.hooshyar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@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
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