Effect of Norelgestromin and Ethinylestradiol in Transdermal Patches on the Clinical Outcomes and Biochemical Parameters of COVID-19 Patients: A Clinical Trial Pilot Study

Abstract

The disease caused by SARS-CoV-2 is still considered a global pandemic. Transdermal patches (TP) with immunoregulators such as estrogen and progesterone compounds could be a feasible option to treat COVID-19 because of their accessibility and relative safety. The objective of the current study was to evaluate the additional treatment with norelgestromin and ethinylestradiol in TP on the clinical and biochemical evolution of COVID-19 patients. The present is a clinical-trial pilot study that included subjects diagnosed with COVID-19, randomized into two groups; the experimental Evra® TP (norelgestromin 6 mg and ethinylestradiol 0.60 mg) was administered such that it was applied on arrival and replaced at day 8 and day 15. The control continued with the conventional COVID-19 treatment protocol. A blood sample was taken each week in order to evaluate relevant biochemical parameters, clinical signs, and evolution. In total, 44 subjects participated in this study, 30 in the experimental group and 14 in the control group. Both groups were homogeneous in terms of age and comorbidities. The experimental group had a significantly lower hospital stay (p = 0.01), high flow supplemental oxygen (p = 0.001), mechanical ventilation (p = 0.003), and intubation (p = 0.01), and the oxygen saturation significantly increased (p = 0.01) in comparison with control group when patients were exposed to room air. A decrease in ferritin (p < 0.05) was observed, with no significant increase in ESR (p > 0.05), D dimer (p > 0.05) and platelets (p > 0.05) in an auto-controlled analysis in the experimental group. Norelgestromin and ethinylestradiol TP could be a safe and effective treatment for moderate and severe COVID-19 patients.

New insights on the potential effect of progesterone in Covid‐19: Anti‐inflammatory and immunosuppressive effects

“…Another clinical trial illustrated the therapeutic effect of P4 treatment in the management of severely hospitalized COVID‐19 patients 91 . In addition, norelgestromin and ethinylestradiol transdermal patches could be safe and effective treatments for moderate and severe COVID‐19 patients 92 . A systematic review showed that hormone replacement therapy was positively associated with reducing COVID‐19 symptoms 93 .…”

“… 91 In addition, norelgestromin and ethinylestradiol transdermal patches could be safe and effective treatments for moderate and severe COVID‐19 patients. 92 A systematic review showed that hormone replacement therapy was positively associated with reducing COVID‐19 symptoms. 93 There is some evidence that P4 contributes to gender differences related to COVID‐19, even though the majority of studies looked at the potential role of estrogen against COVID‐19.…”