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IRCT20230722058883N2 IRCT 2024-03-01 Tehran University of Medical Sciences rosuvastatin and SARS-Cov-2 Prognostic Efficacy of Moderate Intensity rosuvastatin on the Infected cases with SARS-Cov-2 2020-04-19 anticipated 100 Complete https://irct.ir/trial/75649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: COVID-19 patients hospitalized on double beds were considered as the case group, 10 mg rosuvastatin in addition to the inpatient treatment protocol (hydroxychloroquine and atazanavir). However, the patients who were hospitalized in individual beds were randomly assigned to the control group, treated only with the inpatient protocol (hydroxychloroquine and atazanavir) (control group). Block randomization In order to minimize distortions, we plan to allocate eligible patients to two groups receiving rosuvastatin in addition to the inpatient treatment protocol (hydroxychloroquine and atazanavir) (intervention (A) and receiving the only inpatient treatment protocol (hydroxychloroquine) by the block random assignment method chloroquine and atazanavir) (intervention B), we divide each group with a population of 50 people. 1- The number of patients in each block: since we have two types of interventions, we consider the number of patients in each block to be 4 (double the number of interventions). If we determine the number of patients in each block to be less or more, they are similar to sequential randomization and simple randomization, which are associated with distortions. 2- The number of required blocks: Since the sample size is calculated to be 100 people and the number of patients in each block is 4, we need 25 blocks. 3- Types of blocks: Since the number of patients in each block is 4 (Bc) and the number of types of interventions (Tn) is two, we have 6 types of blocks using the formula below. We randomly assigned a number to each type of block. 1.AABB 2.ABAB 3.ABBA 4.BABA 5.BBAA 6.BAAB 4- The maximum number of repetitions allowed to select each block: since the number of required blocks is more than the number of types of blocks, we have to use each block more than once. To reduce torsion, the best possible situation is to use 2 types of blocks 4 times and other blocks 3 times. 5- Random selection of the type of blocks: At first, using the minitab statistical software and setting the base set equal to 1 and the random data section of the software, blocks 1 and 4, which are supposed to be used 4 times, were randomly selected. Then again, using set base equal to 1, we reached the following random sequence from left to right: 1-4-4-6-2-6-1-2-1-4-5-5-3-4-3-6-1-3-2-5 6- Random selection of the block sequence: to each of the blocks selected in the previous section, we assign the numbers 1 to 20 in order from left to right. ) then using the minitab statistical software and setting the base set equal to 1, we get the following random sequence of numbers from 1 to 20: 7-4-18-19-17-13-9-12-14-5-2-11-20-3-6-8-15-1-10-16 Thus, the final sequence of blocks is as follows: 1-6-3-2-1-3-1-5-4-2-4-5-5-4-6-2-3-1-4-6 7- The final sequence of interventions: taking into account the final sequence obtained in the previous section and that each number represents the sequence of interventions (section 3), we implement the interventions in the following order from left to right in eligible patients: AABB, BAAB, ABBA, ABAB, AABB, ABBA, AABB, BBAA, BABA, ABAB, BABA, BBAA, BBAA, BABA, BAAB, ABAB, ABBA, AABB, BABA, BAAB In other words, the first patient received rosuvastatin in addition to the inpatient treatment protocol (hydroxychloroquine and atazanavir), the second patient received rosuvastatin in addition to the inpatient treatment protocol (hydroxychloroquine and atazanavir), the third patient received only the inpatient treatment protocol (hydroxychloroquine and atazanavir) and... they do, Blinding description: This was a double-blind trial, meaning the questionnaires of patients in the intervention and control group were coded, and then randomly selected according to the number of the hospitalized bed, and during the follow-up time at one month later, neither the researcher nor the patient was informed of the content of the injection. 3 The health condition studied in "Prognostic Efficacy of Moderate Intensity rosuvastatin on the Infected cases with SARS-Cov-2" pertains to individuals diagnosed with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. COVID-19 manifests with a spectrum of clinical presentations ranging from asymptomatic or mild respiratory symptoms to severe pneumonia, acute respiratory distress syndrome (ARDS), and multiorgan dysfunction. This study focuses on evaluating the prognostic efficacy of moderate-intensity rosuvastatin therapy in COVID-19 patients, with a particular emphasis on disease severity, progression to severe complications, and mortality. By investigating the impact of rosuvastatin on clinical outcomes in individuals infected with SARS-CoV-2, the study aims to contribute valuable insights into the potential role of statins as adjunctive therapy in managing COVID-19 and improving patient outcomes.. Intervention 1: Intervention group: 10 mg of rosuvastatin in addition to the inpatient protocol treatment (hydroxychloroquine and atazanavir). Intervention 2: Control group: only the treatment of the inpatient protocol (hydroxychloroquine and atazanavir). 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 None
public Samaneh Parsa
End of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 samaneh_parsa@yahoo.com Tehran University of Medical Sciences scientific Samaneh Parsa
End of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 samaneh_parsa@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients who were not currently taking statin treatment patients who had a confirmed diagnosis of COVID-19 based on imaging or PCR results. 30 years 70 years Both patients with known liver disease, cirrhosis, autoimmune hepatitis, chronic viral hepatitis, rhabdomyolysis myopathy, severe kidney disease, a history of statin sensitivity, and higher-than-normal ALT and CPK in the initial test. Patients who had previously taken statins at different dosages as well as women who were pregnant or nursing If the patient developed symptoms of hepatitis or myopathy, muscle weakness and increased liver and muscle enzymes after taking statin U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: 10 mg of rosuvastatin in addition to the inpatient protocol treatment (hydroxychloroquine and atazanavir) Control group: only the treatment of the inpatient protocol (hydroxychloroquine and atazanavir) The severity of disease was evaluated based on the following variables: the temperature measured by thermometer and arterial oxygen saturation measured by pulse oximeter; observation of vital signs including heart and respiratory rate on the first day of hospitalization and the day of discharge; CBC-related information including the level of CRP, ESR, WBC, Plt, ALT and CPK at the beginning of hospitalization and on the day of discharge; length of hospitalization as well as the need for ICU and intubation; shortness of breath assessed based on the Borg questionnaire and cough based on the LCQ questionnaire on the first day and at the time of discharge and after two weeks of statin administration (evaluated by phone call); and lastly, one-month mortality in cases and controls. Timepoint: on the first day and at the time of discharge and after two weeks and 1 month of statin administration. Method of measurement: thermometer, pulse oximeter, CBC, Borg questionnaire and LCQ questionnaire. Tehran University of Medical Sciences Approved 2020-04-05 Research Ethics Committees of Vice-Chancellor in Research Affairs- Tehran University of Medical Scie End of Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)