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IRCT20200509047364N2 IRCT 2020-08-17 Bandare-abbas University of Medical Sciences Famotidine and COVID-19 The effect of Famotidine on the improvement of patients with COVID-19 2020-06-21 anticipated 20 Complete https://irct.ir/trial/49657 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 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 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 Famotidine 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. 3 Laboratory confirmed COVID-19. Intervention 1: Intervention group: Group A receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Vital signs of patients are also checked at regular intervals and frequently. Standard pharmacotherapy according to the treatment protocols of the National Committee of 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. 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 receives standard drug therapy according to the treatment protocols of the National Committee COVID-19 and placebo in the form of oral tablets four times a day, daily until patients are discharged, for a maximum of fourteen days. Standard pharmacotherapy according to the treatment protocols of the National Committee of 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. 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 COVID-19 patients whose disease has been confirmed by the PCR test for SARS-Cov-2. Signing the written consent of the study participant. no limit no limit Both All Immunocompromised patients End stage renal disease Moderate renal insufficiency (creatinine clearance 30-50 mL/min) stage 4 sever chronic kidney disease requiring dialysis (i.e creatinine clearance <30 mL/min) History of hepatic disease History of hepatitis C infection History of alcoholism G-6-PD (glucose-6-phosphate dehydrogenase deficiency) ALT/AST >5 times the upper limit of normal. History of or evidence of QT prolongation on ECG examination History of psoriasis History of porphyria Pregnancy Use of oral contraceptive pills (OCP) Concomitant use of Dasatinib Concomitant use of Neratinib Concomitant use of Ozanimod Concomitant use of Pazopanib Concomitant use of Rilpivirine Concomitant use of Siponimod Concomitant use of Tizanidine Allergy to any study medication U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Group A receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Vital signs of patients are also checked at regular intervals and frequently. Standard pharmacotherapy according to the treatment protocols of the National Committee of 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. 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 receives standard drug therapy according to the treatment protocols of the National Committee COVID-19 and placebo in the form of oral tablets four times a day, daily until patients are discharged, for a maximum of fourteen days. Standard pharmacotherapy according to the treatment protocols of the National Committee of 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. 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 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter. Oxygen saturation state. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter. Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Chest X-ray. Lactate Dehydrogenase(LDH) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory. C-reactive protein(CRP) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory. Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory. Platelet count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory. Patient temperature status. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Digital thermometer. Length of hospitalization. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Record patient information. Length of Intensive Care Unit admission. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Record patient information. Bandare-abbas University of Medical Sciences Approved 2020-08-02 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)