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IRCT20200509047364N1 IRCT 2020-08-09 Bandare-abbas University of Medical Sciences Effect of erythropoietin on COVID-19 Evaluation of the efficacy and safety of recombinant erythropoietin on the improvement of hospitalised COVID-19 patients 2020-06-21 anticipated 20 Complete https://irct.ir/trial/49282 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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.), 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. 2 Laboratory confirmed COVID-19. Intervention 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 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This study is not over yet.
public Dariush Hooshyar
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 990 038 7226 dariush.hooshyar@gmail.com Bandare-abbas University of Medical Sciences scientific Dr. Mitra Kazemijahromi
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 917 791 2820 mitra.kazemijahromi@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) 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 no limit 65 years Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Placebo 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 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 Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: Pulse oximeter. 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. 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. LDH level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory. CRP level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory. Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory. Endogenous erythropoietin level's. Timepoint: Beginning of study (before intervention). Method of measurement: Pathobiology laboratory. Patients' blood pressure. Timepoint: At the beginning of the study (before the intervention), during the intervention (5-day erythropoietin administration). Method of measurement: Sphygmomanometer. 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. Bandare-abbas University of Medical Sciences Approved 2020-06-06 Ethics committee of Hormozgan University of Medical Sciences Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran bandar abbas Hormozgan Iran (Islamic Republic of)