Estetrol (E4) for the Treatment of Patients With Confirmed SARS-COV-2 Infection
Status:
Active, not recruiting
Trial end date:
2022-08-05
Target enrollment:
Participant gender:
Summary
It has been reported in several research studies that men are almost twice as likely to
progress to severe COVID 19 disease and die than women. Some researchers have suggested this
is due to the activity of estrogen which is produced by the ovaries in pre-menopausal women.
Men and post-menopausal women produce very low levels of estrogen. This study will look
whether E4, a natural estrogen, can help men and post-menopausal women that are hospitalized
with COVID 19 infection but for whom help breathing is not yet needed.
The study has 2 parts. In Part A, 162 patients will be randomized (81 patients in the E4
treatment arm and 81 patients in the placebo treatment arm). The data collected from patients
in Part A will address the primary and secondary objectives of the study. Once all patients
in Part A have been randomized and Part A analysis is complete, assuming positive data,
recruitment and double-blind randomization of patients will continue into Part B, unchanged,
on 1:1 basis to E4 and placebo.