Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial

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 χ2. 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.

Atorvastatin for Reduction of 28-day Mortality in Sever and Critical COVID-19 Patients: A Randomized Controlled Trial

“…The strengths of the current study include: the randomized controlled and double-blind design that reduced the risk of allocation and performance bias; the inclusion of DSMB; the long-term follow-up (six months); and the published protocol. 15 Despite being insigni cant, the reduction in six-month mortality in the atorvastatin group (52% vs 60.8%) suggests that this hypothesis should be tested further. Furthermore, future studies would look into the effect of statins on subgroups (severe or critical cases).…”

“…14 For detailed methodology and related documents, the reader can nd the published protocol. 15 Two hundred and twenty adult patients (≥ 18 years old) with severe or critical COVID-19 who were admitted to the Mansoura University isolation hospital -from 18th August 2021 to 6th October 2021 -were included in the study.…”