Abstract
Background: Although mass vaccination has reduced the severity of COVID-19, mortality is still high among hospitalized patients. Being a sepsis-like disease, an anti-inflammatory drug as atorvastatin would reduce mortality and severity in COVID-19.
Methods: We designed a randomized clinical trial that recruited 220 COVID-19 patients admitted in the COVID-19 isolation hospital at Mansoura University, Egypt. One hundred ten cases were assigned to receive 40 mg atorvastatin once daily for 28 days, and 110 were assigned to receive placebo. Delta Pharm company supported the study with the drug and the placebo, which mimics the drug as regards the drug package, the tablet color, consistency, and size. All patients received the standard treatment as per the hospital protocol. The Institutional Review Board approval and the informed consent from all participants were obtained. The primary outcome is the 28-day all-cause mortality. Additionally, we will collect the in-hospital mortality, the need for mechanical ventilation, time to clinical improvement, in-hospital thrombo-embolic events, acute kidney injury, and the hospital and the intensive care duration of stay. We plan to follow the patients up for 6 months for reporting mortality and long-term neurological, psychological, and respiratory consequences. We will report the un-adjusted 28-mortality using χ 2 . Then, we will report the adjusted odds ratio with a pre-planned multiple logistic regression model. We will report our results using the point estimate and the 95% confidence interval and the P-value.
Discussion: The additional issue that we would like to discuss is the added workload on the clinicians and the allied healthcare workers who performed research at the time of the pandemic. Therefore, doing research at the pandemic era was, indeed, challenging.
Trial registration: The study was registered at the Clinical Trial Registry ( NCT04952350 ) on July 1st, 2021.
Keywords: Atorvastatin; COVID-19; Coronavirus; Hmg coa; Mortality; Randomized controlled trial; SARS-CoV-2; Statins.
【저자키워드】 COVID-19, Randomized controlled trial, SARS-CoV-2, coronavirus, Mortality, atorvastatin, statins, Hmg coa, 【초록키워드】 Randomized controlled trial, randomized clinical trial, vaccination, pandemic, protocol, intensive care, mechanical ventilation, severity, hospital, Delta, Sepsis, Acute kidney injury, drug, hospitalized patients, healthcare worker, Consequences, severity of COVID-19, clinical, Research, Patient, pandemic era, Clinical improvement, atorvastatin, Placebo, Informed consent, Psychological, registry, university, disease, in-hospital mortality, statins, neurological, COVID-19 patient, once daily, mass vaccination, institutional review board, In-hospital, Tablet, Consistency, adjusted odds ratio, Primary outcome, isolation hospital, P-value, clinician, 95% confidence interval, standard treatment, All participants, logistic regression model, all-cause mortality, Registered, approval, participant, anti-inflammatory drug, being, reduce mortality, performed, recruited, the patient, events, reduced, supported, added, assigned, receive, 【제목키워드】 clinical trial, Study protocol, 28-day mortality, Randomized, placebo-controlled, reduction, double-blinded, hospitalized COVID-19,