NCT04801836

Estetrol (E4) for the Treatment of Patients With Confirmed SARS-COV-2 Infection

A Randomized, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of Estetrol (E4) for the Treatment of Patients With Confirmed SARS-COV-2 Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: NEURALIS s.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Estetrol monohydrate 15 mg	One Estetrol monohydrate (E4) 15 mg tablet once per day
DRUG	Placebo	One placebo tablet once per day

Timeline

• Start date: 2020-11-19
• Primary completion: 2022-03-04
• Completion: 2022-08-05
• First posted: 2021-03-17
• Last updated: 2021-08-02

Locations

25 sites across 4 countries: Belgium, Hungary, Poland, Russia