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IRCT20200516047468N1 IRCT 2020-05-19 Shahid Beheshti University of Medical Sciences Investigation of the effect of intravenous vitamin C on definite patients with coronavirus pneumonia VCACS Interventional study of intravenous vitamin C in definitive patients with covid 19 and its effect on changes in lung CT scan and clinical and laboratory symptoms of patients 2020-04-08 anticipated 50 Complete https://irct.ir/trial/48176 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization is used. Patients eligible to enter the study are randomly selected from a table of numbers and divided into control and intervention groups, Blinding description: In this study, patients with covid 19 who have the conditions to enter the study are first explained about the possible effects of vitamin C on their disease and consent is obtained to start the drug. The intravenous vitamin C is then injected into a group and the placebo is injected into the control group. Laboratory staff and radiologists who report CT scans of patients are unaware of the names of patients in the control group. 2-3 COVID 19 PNEUMONIA. Intervention 1: Intervention group: In this group of patients, intravenous vitamin C is injected at a dose of 2 grams every 6 hours for five days. The manufacturer of this drug is Iran Daroupakhsh Company. Patients in the intervention group, in addition to intravenous vitamin C, are used diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients. Intervention 2: Control group: In patients of this group, placebo is injected for five days. Patients in the control group, in addition to placebo, used the medicinal diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients. Yes - There is a plan to make this available What will be shared: All patient data can be shared after people have not been identified. When: Start access 3 months after printing the results To whom: Data can be provided to all individuals and institutions. Conditions: Individuals applying for data must have a valid ID card, the purpose of receiving the data must be explained and it must be guaranteed that the data will not be published. Where to obtain: To receive data, refer to the office of the Infectious Diseases Department of Labafinejad Hospital in Tehran. Address: Tehran, Pasdaran, 9th Bustan Street How to obtain: After the applicant comes in person with the required documents, the data will be provided to her after three days. Comments:
public Hamideh Moradi Shahr Babak
Unit 3, No. 4, Ebrahimi Alley, Shahid Madani St., Nezam Abad, Tehran
Tehran Iran (Islamic Republic of) 1616663914 +98 34 3411 2418 hamidehmoradi05@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamideh Moradi Shahr Babak
Unit 3, No. 4, Ebrahimi Alley, Shahid Madani St., Nezam Abad, Tehran
Tehran Iran (Islamic Republic of) 1616663914 +98 34 3411 2418 hamidehmoradi05@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who have a positive corona pcr test. Patients over 18 years of age. Oxygen saturation should be below 93%. The patient's respiratory rate should be more than 30 per minute. Lung involvement in chest or CT scans of the lungs is more than 50 percent. 18 years no limit Both Allergy to vitamin C The patient's shortness of breath may be due to cardiac pulmonary edema Be pregnant or breastfeeding Have chronic kidney disease Be in diabetic ketoacidosis Have kidney stones U07.1 This code assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing. Treatment - Drugs Placebo Intervention group: In this group of patients, intravenous vitamin C is injected at a dose of 2 grams every 6 hours for five days. The manufacturer of this drug is Iran Daroupakhsh Company. Patients in the intervention group, in addition to intravenous vitamin C, are used diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients. Control group: In patients of this group, placebo is injected for five days. Patients in the control group, in addition to placebo, used the medicinal diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients. The amount of lung involvement in a CT scan: According to the radiologist, the appearance of lung involvement and the percentage of lung involvement are measured. Timepoint: Five days after receiving vitamin C intravenously. Method of measurement: According to the radiologist, the appearance of lung involvement and the extent of lung involvement are scoring. Oxygen saturation rate of patients. Timepoint: Five days after receiving vitamin C intravenously. Method of measurement: Using an pulse oxymeter. Respiratory rate of patients. Timepoint: Five days after receiving vitamin C intravenously. Method of measurement: Examination by a doctor. Serum CRP level. Timepoint: Five days after receiving vitamin C intravenously. Method of measurement: Report by Laboratory. Lymphopenia rate. Timepoint: Five days after receiving vitamin C intravenously. Method of measurement: Report by Laboratory. Mortality rate. Timepoint: At the end of the patient's hospitalization. Method of measurement: report by doctor. Duration of hospitalization. Timepoint: At the end of the patient's hospitalization. Method of measurement: Calculated by a physician. Intubation rate. Timepoint: At the end of the study. Method of measurement: Calculated by the analyzer. Shahid Beheshti University of Medical Sciences Approved 2020-05-04 Shahid Beheshti University of Medical Sciences Third Floor, Faculty of Medicine, Next to Taleghani Hospital, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)