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IRCT20200408046990N3 IRCT 2020-07-16 Mashhad University of Medical Sciences Evaluation of atorvastatin tablet as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem Hospital, Mashhad Evaluation of atorvastatin tablet efficacy as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem Hospital, Mashhad: A double-blind randomized placebo controlled clinical trial 2020-07-21 anticipated 40 Complete https://irct.ir/trial/49629 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the help of a randomization list provided by randomization.com site, patients will receive code 1 or 2 and will be included in placebo or medication group, Blinding description: The atorvastatin and placebo tablets will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician. Data collection and analysis are performed by the medical resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis. 2 COVID-19 pneumonia. Intervention 1: Intervention group: one atorvastatin 40mg tablet daily for two weeks. Intervention 2: Control group: placebo with same appearance of atorvastatin tablet one daily for 2 weeks. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Sepideh Elyasi
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Laboratory or clinical diagnosis of COVID-19 with admission indication age between 18-65 y sign of the written consent not concomitant use of kaletra or other PIs, cyclosporine, colchicine, ciproterone, danazol, gemfibrozil, potent CYP3A4 inhibitors or inducers like macrolides, CCBs, Azoles, rifampin, phenytoin not using statin before including in the study 18 years 65 years Both history of allergy to statins pregnancy and lactation active liver disease or rise of LFT during study including in other studies start of PIs ADR occurrence e.g. rhabdomyolysis severe renal failure (GFR<30 ml/min) indication for intubation or ICU not being able to swallow medication U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: one atorvastatin 40mg tablet daily for two weeks Control group: placebo with same appearance of atorvastatin tablet one daily for 2 weeks Fever. Timepoint: daily. Method of measurement: thermometer. Clinical response to treatment (including improvement of cough, myalgia, headache, Olfactory and taste disorders). Timepoint: daily. Method of measurement: based on patients examination and interview. Radiologic response. Timepoint: two weeks after treatment. Method of measurement: lung CT scan. Laboratory response. Timepoint: weekly. Method of measurement: assessment of serum level of CRP and CBC diff. Drug adverse reaction. Timepoint: daily. Method of measurement: patient file and interview. Duration of hospitalization. Timepoint: end of the treatment. Method of measurement: patients' file. Patients' clinical outcome. Timepoint: at the of the treatment. Method of measurement: patients' file. Mashhad University of Medical Sciences Approved 2020-05-06 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)