Prognostic Efficacy of Moderate Intensity rosuvastatin on the Infected cases with SARS-Cov-2

we designed an open-label clinical trial to investigate the prognostic efficacy of moderate-intensity rosuvastatin therapy in individuals infected with SARS-CoV-2. By evaluating key clinical endpoints such as disease severity, progression to severe complications, and mortality, we aim to provide valuable insights into the role of rosuvastatin in the management of COVID-19.

Two arm parallel group randomised trial with blinded postoperative care and outcome assessment

An interventional study conducted on 100 patients hospitalized with COVID-19. In this study, patients were randomly assigned into case and intervention group, all participants were prescribed standard treatment regimen. In the intervention group, patients were commenced on rosuvastatin at dose of 10 mg once daily for two weeks as add-on standard care.

The inclusion criteria included patients who were not currently taking statin treatment and had a confirmed diagnosis of COVID-19 based on imaging or PCR results. The exclusion criteria included 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 were not included. If the patient developed symptoms of hepatitis or myopathy, muscle weakness and increased liver and muscle enzymes after taking statin, the drug was discontinued and the patient was excluded from the study.

10 mg of rosuvastatin

disease severity, progression to severe complications, and mortality

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.

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.