Estrogen Therapy in Non-severe COVID-19 Patients

NCT ID: NCT04539626

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-12-31

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 ACE2/Ang 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 0.60mg and 2) control: who will receive conventional treatment

Conditions

Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Estrogen Therapy

Drug: Norelgesetromin 6mg / Ethinyl estradiol 0.60mg

Dosage form: EVRA skin patches with norelgesetromin 6mg / ethinyl estradiol 0.60mg, (1 patch will be placed every week during 21 days)

Group Type: EXPERIMENTAL

Estrogen Therapy

Intervention Type: DRUG

EVRA skin patches with norelgesetromin 6mg / ethinyl estradiol 0.60mg, (1 patch will be placed every week during 21 days)

Control Group

Patients who will receive conventional COVID-19 treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Estrogen Therapy

EVRA skin patches with norelgesetromin 6mg / ethinyl estradiol 0.60mg, (1 patch will be placed every week during 21 days)

Intervention Type: DRUG

Other Intervention Names

Norelgesetromin; Ethinyl estradiol

Eligibility Criteria

Inclusion Criteria

• Male ≥ 18 years of age and female ≥ 55 years of age
• Diagnosis of positive SARS-CoV-2 infection confirmed by clinical diagnosis and / or RT-PCR test
• Hospitalized patients in acute disease* stages of the disease
• Agree to participate in the study prior to signing an informed consent.
• Patients with conventional treatment with anticoagulants (Noxaparin)

• Acute disease: patients who are hospitalized, conscious, not intubated, with biochemical values of D-Dimer> 2, Ferritin> 1000 u.

Exclusion Criteria

• Patients with abnormal genital bleeding
• Patients with protein C or protein S deficiency
• Patients with liver failure (cirrhosis, hepatitis C)
• Patients with history of allergic reaction to estrogens use
• Patients receiving lamotrigine therapy
• Patients with a history of breast cancer and / or endometrial cancer
• Patients with severe hypoxia at risk of acute intubation in ED
• Patients with a history of cerebrovascular history
• Male patients with testosterone treatment
• Patients with a history of myocardial infarction, who have cardiac stents and / or unstable angina pectoris
• Patients with previous hormonal treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMN "20 de Noviembre"

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Cortés Algara

Gynecology Service Member, MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Ruz Barros, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Daniel Santillán Cortés, MSc

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Mónica Escamilla Tilch, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Juan A Pineda Juárez, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Sandra Muñoz López, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Maricela Escarela Serrano, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Paul Mondragón Terán, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Alberto H De la Vega Bravo, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Alfredo L Cortés Algara, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CMN "20 de Noviembre"

Samuel Reyes-Long, MSc

Role: STUDY_CHAIR

Neurociencias básicas, Instituto Nacional de Rehabilitación LGII

Cindy Bandala, MD MSc PhD

Role: STUDY_CHAIR

Neurociencias básicas, Instituto Nacional de Rehabilitación LGII; Escuela Superior de Medicina, Instituto Politécnico Nacional

Locations

CMN "20 de Noviembre"

Mexico City, Benito Juárez, Mexico

Countries

Mexico

Other Identifiers

03

Identifier Type: -

Identifier Source: org_study_id