6/28/23, 11:36 PM INSPIRATION-S Pathway Feedback Search Clinical Topics Home Studies INSPIRATION S INSPIRATION S Disease COVID 19 infection Trial question What is the role of atorvastatin in critically ill adult patients with COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.0% female N = 587 56.0% male 587 patients (256 female, 331 male) Inclusion criteria: adult patients with COVID-19 admitted to the ICU Key exclusion criteria: estimated survival < 24 hours; weight < 40 kg; major bleeding or serious bleeding diathesis within 30 days from enrollment; liver enzymes > 5 times the ULN; active liver disease; CK concentration > 500 U/L Interventions N=290 atorvastatin (20 mg per oral daily for 30 days) N=297 placebo (matching placebo) Primary outcome Venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or death from any cause at day 30 36.0 % 36 33 27 0 % https://web.pathway.md/studies/reczogvBxu5TNFfxR 1/2 6/28/23, 11:36 PM 27.0 % INSPIRATION-S Pathway 18.0 % 9.0 % No significant difference 0.0 % Atorvastatin Placebo No significant difference in venous or arterial thrombosis, treatment with ECMO, or death from any cause at day 30 (33% vs. 36%; OR 0.84, 95% CI 0.58 to 1.21) Secondary outcomes No significant difference in death from any cause (31% vs. 35%; OR 0.84, 95% CI 0.58 to 1.22) No significant difference in VTE (2% vs. 3%; OR 0.71, 95% CI 0.24 to 2.06) No significant difference in arterial thrombosis (ARD -0.3, 95% CI -0.9 to 0.3) Safety outcomes No significant differences in elevated liver enzymes, fatal bleeding. Conclusion In adult patients with COVID-19 admitted to the ICU, atorvastatin was not superior to placebo with respect to venous or arterial thrombosis, treatment with ECMO, or death from any cause at day 30. Reference INSPIRATION-S Investigators. Atorvastatin versus placebo in patients with covid-19 in intensive care: randomized controlled trial. BMJ. 2022 Jan 7;376:e068407. Open reference URL https://web.pathway.md/studies/reczogvBxu5TNFfxR 2/2