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IRCT20110510006431N6 IRCT 2022-10-29 Shahid Beheshti University of Medical Sciences The effect of alpha-1-antitrypsin on the progression of covid-19 disease Evaluation of the effects of alpha-1-antitrypsin on the progression of covid-19 disease: a randomized control trial 2022-11-22 anticipated 50 Complete https://irct.ir/trial/66460 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were divided into two groups based on the level of AAT serum by Stratified Blocked Randomization. a random sequence will generate. For this purpose, we will use random sequence generation software. We will calculate random sequences in the range of 1-2 using the stat trek software (https://stattrek.com/statistics/random-number-generator.aspx) for two groups one and two (for example: 2 1 1 2 1 2 1 1 2 2 1 1 2 1 2 2 2 1 1 2 1 2 1 ...........). The numbers 1 are assigned to the intervention group 1 (alpha-1-antitrypsin) and the numbers 2 are assigned to the control group. Each number will represent a group according to the defined numbers. With this method, at the end, we will have a specific sequence of codes 1 and 2, which shows the blocks who are going to be included in the study, in which group they should be placed. We wrote the codes on a piece of paper and put them in an envelope to use during sampling. In this way, after checking the entry criteria and if the client wishes, we will enter each block entered into the study into the groups according to our predetermined list, Blinding description: In order to blind the patient, the researcher and the clinical caregiver, the alpha-1-antitrypsin and placebo will be used that have the same appearance, but the patient, the researcher and the health care provider will not be informed that each person is using the alpha-1-antitrypsin or the placebo. 3 covid-19. Intervention 1: Intervention group: receiving alpha 1 antitrypsin drug. Type a 1-glycoprotein is a relatively small and polar molecule that acts as an extracellular inhibitor of serine proteases. This enzyme is one of the first defense proteins of the body. The dosage is 60 mg/kgBW as an injection once a week. for four weeks. Intervention 2: Control group: normal saline 0.9% with the same dose and repetition and time as the interfering substance. 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 Still undecided - no release schedule yet
public Mahdi shadnoush
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahdi shadnoush
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age above 18 years The presence of shortness of breath Positive PCR test for corona or lung involvement in imaging Signing informed consent and readiness to participate in the plan 18 years no limit Both Patients suffering from underlying diseases including pulmonary hypertension, kidney failure, seizures, depression, chronic hepatitis, cirrhosis and cholestatic liver diseases and pulmonary embolism (in the past 3 months) Use of anti-coagulant drugs such as warfarin, hormonal drugs and other illegal drugs (within the past 30 days) Alcohol consumption Pregnancy or breastfeeding Allergy to AAT drug Having IgA deficiency No smoking in the last 6 months U07.1 COVID-19 Treatment - Drugs Placebo Intervention group: receiving alpha 1 antitrypsin drug. Type a 1-glycoprotein is a relatively small and polar molecule that acts as an extracellular inhibitor of serine proteases. This enzyme is one of the first defense proteins of the body. The dosage is 60 mg/kgBW as an injection once a week. for four weeks. Control group: normal saline 0.9% with the same dose and repetition and time as the interfering substance The ratio of neutrophils to lymphocytes. Timepoint: At the first and at the 4th week of the study. Method of measurement: immunoassay. ESR. Timepoint: At the first and at the 4th week of the study. Method of measurement: Westergren method and ESR tube. CRP. Timepoint: At the first and at the 4th week of the study. Method of measurement: Spectrophotometry. IL-6. Timepoint: At the first and at the 4th week of the study. Method of measurement: immunoassay. Mortality rate. Timepoint: the 4th week of the study. Method of measurement: observation. Hospitalization time. Timepoint: the 4th week of the study. Method of measurement: observation. Shahid Beheshti University of Medical Sciences Approved 2022-10-02 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Yemen St. - Shahid Arabi St Tehran Tehran Iran (Islamic Republic of)