Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774405
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2023-03-15
Brief Title:
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients A Randomized Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
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:
The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease
The main questions it aims to answer are
the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time
As an intervention transdermal estradiol patch 78 mg patchweek was applied for 14 days on the upper buttock of the patients in experimental arm As a placebo hydrogel patch adhesive hydrogel patchweek was applied to the female patients for 14 days
Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease
The main questions it aims to answer are
the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time
As an intervention transdermal estradiol patch 78 mg patchweek was applied for 14 days on the upper buttock of the patients in experimental arm As a placebo hydrogel patch adhesive hydrogel patchweek was applied to the female patients for 14 days
Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease
Detailed Description:
The risk of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection morbidity and mortality from Covid-19 disease were higher among men compared to women This is caused by the differences in immunological response and viral pathogenesis between men and women It is theoretically assumed that estrogen has a positive impact on female COVID-19 patients In this randomized placebo-controlled study we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease Female patients diagnosed with Covid-19 disease were examined and only postmenopausal women were included into the study The COVID-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction RT-PCR test given with nasal and oral swabs All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time
As an intervention transdermal estradiol patch 78 mg patchweek was applied for 14 days on the upper buttock of the patients in experimental arm As a placebo hydrogel patch adhesive hydrogel patchweek was applied to the female patients for 14 days
Our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease The epidemiological and clinical data the results of biochemical analysis the information regarding the treatment and outcomes and serum estradiol levels were determined
As an intervention transdermal estradiol patch 78 mg patchweek was applied for 14 days on the upper buttock of the patients in experimental arm As a placebo hydrogel patch adhesive hydrogel patchweek was applied to the female patients for 14 days
Our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease The epidemiological and clinical data the results of biochemical analysis the information regarding the treatment and outcomes and serum estradiol levels were determined
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?:
False
Is an FDA AA801 Violation?:
None