Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801836
Status:
UNKNOWN
Last Update Posted:
2021-08-02
First Post:
2021-03-12
Brief Title:
Estetrol E4 for the Treatment of Patients With Confirmed SARS-COV-2 Infection
Sponsor:
NEURALIS sa
Organization:
NEURALIS sa
Study Overview
Official Title:
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
Status Verified Date:
2021-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 basis to E4 and placebo
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 11 basis to E4 and placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003403-33 | EUDRACT_NUMBER | None | None |