]>
IRCT20200509047364N3 IRCT 2021-02-20 Bandare-abbas University of Medical Sciences The effect of N-Acetylcysteine on COVID-19 Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial 2021-03-02 anticipated 40 Complete https://irct.ir/trial/54372 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 N-Acetylcysteine 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 drug therapy based on the treatment protocols of the National Committee COVID-19 and N-Acetylcysteine (Exi-Nac 2g/10ml AMP (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 g as a slow single intravenous injection on the first day of hospitalization. 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 based on the treatment protocols of the National COVID-19 Committee and placebo as a slow single intravenous injection on the first day of hospitalization. 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. Having one of the criteria for severe COVID-19 disease includes tachypnea (respiration rate> 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), LDH> 245 U / l, Progressive lymphopenia. Hospitalized in the intensive care unit. Signing the written consent of the study participant. no limit no limit Both Known allergy or hypersensitivity to N-Acetylcysteine. Pregnancy The participant refused to participate in the continuation of the study. U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Group A receives standard drug therapy based on the treatment protocols of the National Committee COVID-19 and N-Acetylcysteine (Exi-Nac 2g/10ml AMP (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 g as a slow single intravenous injection on the first day of hospitalization. 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 based on the treatment protocols of the National COVID-19 Committee and placebo as a slow single intravenous injection on the first day of hospitalization. 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. Patient's clinical condition. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Clinical examinations. Length of Intensive Care Unit admission. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Record patient information. 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. Bandare-abbas University of Medical Sciences Approved 2021-02-14 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)