| Autor: |
Foidart JM; Mithra Pharmaceuticals, 4000 Liège, Belgium.; Department of Obstetrics and Gynecology, University of Liège, 4000 Liège, Belgium., Simon K; Department of Infectious Diseases and Hepatology, Wrocław Medical University, 51149 Wrocław, Poland., Utian WH; Department of Reproductive Biology, Case Western Reserve Medical School, Cleveland, OH 44106, USA., Mauvais-Jarvis F; Department of Endocrinology and Metabolism, Tulane University School of Medicine, New Orleans, LA 70112, USA., Douxfils J; Department of Pharmacy, Namur Thrombosis and Hemostasis Center, Faculty of Medicine, University of Namur, 5000 Namur, Belgium.; QUALIblood s.a., 5000 Namur, Belgium., Dixon G; Mithra Pharmaceuticals, 4000 Liège, Belgium., Barrington P; tranScrip Ltd., Wokingham RG41 5TP, Berkshire, UK. |
| Abstrakt: |
Epidemiological data suggest that the severe acute respiratory syndrome coronavirus 2 infection rate is higher in women than in men, but the death rate is lower, while women (>50 years) on menopausal hormone therapy (MHT) have a higher survival rate than those not on MHT. Classical oral estrogen enhances the synthesis of coagulation markers and may increase the risk of thromboembolic events that are common in coronavirus disease 2019 (COVID-19). The favorable hemostatic profile of estetrol (E4) might be suitable for use in women who are receiving estrogen treatment and contract COVID-19. A multicenter, randomized, double-blind, placebo-controlled, phase 2 study (NCT04801836) investigated the efficacy, safety, and tolerability of E4 versus placebo in hospitalized patients with moderate COVID-19. Eligible postmenopausal women and men (aged ≥ 18 years old) were randomized to E4 15 mg or placebo, once daily for 21 days, in addition to the standard of care (SoC). The primary efficacy endpoint of improvement in COVID-19 (percentage of patients recovered at day 28) between the placebo and E4 arms was not met. E4 was well tolerated, with no safety signals or thromboembolic events, suggesting that postmenopausal women can safely continue E4-based therapy in cases of moderate COVID-19 managed with SoC. |
