Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539626
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-05
First Post:
2020-09-03
Brief Title:
Estrogen Therapy in Non-severe COVID-19 Patients
Sponsor:
CMN 20 de Noviembre
Organization:
CMN 20 de Noviembre
Study Overview
Official Title:
Estrogen Therapy in Non-severe COVID-19 Patients Proposed Treatment Scheme in a Tertiary Hospital
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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 primary objective of this study is to evaluate the effect of additional estradiol estrogen therapy on clinical response and mortality in non-severe COVID-19 patients
Detailed Description:
Actually there is not treatment or vaccine that can prevent or control the evolution of COVID-19 The epidemiological data reported in China by the Center for Disease Control CDC on February 2020 reported that 87 of the patients have been adults in an age range of 30-69 years In addition different studies have shown that male gender are more vulnerable for the contagion of the virus 60-80 as well as the clinical evolution of COVID-19 including mortality compared to the female sex 20-40 independently of individual such as diabetes cardiovascular diseases obesity mainly
The mechanism of SARS-CoV-2 infection has been shown to occur with the interaction of angiotensin converting enzyme 2 ACE2 this enzyme is expressed in lungs brain heart kidneys and gastrointestinal tract Also has been shown that older people have higher levels of ACE2 expression Among the different molecular functions of ACE2 are the regulation of cell proliferation cytokine production and inflammatory response
It has been proposed that exogenous human recombinant ACE2 could be an alternative treatment for COVID-19 however this treatment is not yet highly available and could entail high costs Other molecules as estrogens have been proposed in different research groups for its capacity to increase the gene expression of ACE2Ang 1-7 This mechanism could reduce lung and endothelial damage and coagulopathy in COVID-19 patients
So it is relevant to evaluate the effect of additional estradiol estrogen as adjuvant therapeutic element therapy on clinical response and mortality in non-severe COVID-19 patients
A controlled clinical trial will be conducted in a tertiary hospital in Mexico City Mexico Participants will be divide in two groups 1 intervention who will receive EVRA skin patches 1 patch every week during 21 days with norelgesetromin 6mg ethinyl estradiol 060mg and 2 control who will receive conventional treatment
The mechanism of SARS-CoV-2 infection has been shown to occur with the interaction of angiotensin converting enzyme 2 ACE2 this enzyme is expressed in lungs brain heart kidneys and gastrointestinal tract Also has been shown that older people have higher levels of ACE2 expression Among the different molecular functions of ACE2 are the regulation of cell proliferation cytokine production and inflammatory response
It has been proposed that exogenous human recombinant ACE2 could be an alternative treatment for COVID-19 however this treatment is not yet highly available and could entail high costs Other molecules as estrogens have been proposed in different research groups for its capacity to increase the gene expression of ACE2Ang 1-7 This mechanism could reduce lung and endothelial damage and coagulopathy in COVID-19 patients
So it is relevant to evaluate the effect of additional estradiol estrogen as adjuvant therapeutic element therapy on clinical response and mortality in non-severe COVID-19 patients
A controlled clinical trial will be conducted in a tertiary hospital in Mexico City Mexico Participants will be divide in two groups 1 intervention who will receive EVRA skin patches 1 patch every week during 21 days with norelgesetromin 6mg ethinyl estradiol 060mg and 2 control who will receive conventional treatment
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