Estrogen Therapy in Non-severe COVID-19 Patients

NCT04539626 | Unknown DMC

• 1 other identifier: 03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Covid-19

Keywords

COVID-19; Estrogens; Severe Acute Respiratory Syndrome Coronavirus-2

Outcome Measures

Primary Outcomes (3)

• Clinical improve to estrogen therapy in non-severe COVID-19 patients Clinical improve to estrogen therapy in non-severe COVID-19 patients

  * Success rate in reducing hospitalization days * Success rate in no oxygen therapy use (low or high-flow oxygen) * Success rate in no intubation and/or mechanical ventilation * Success rate in non mortality occurrence

  Day 7

• Clinical improve to estrogen therapy in non-severe COVID-19 patients

  * Success rate in reducing hospitalization days * Success rate in no oxygen therapy use (low or high-flow oxygen) * Success rate in no intubation and/or mechanical ventilation * Success rate in non mortality occurrence

  Day 14

• Clinical improve to estrogen therapy in non-severe COVID-19 patients

  * Success rate in reducing hospitalization days * Success rate in no oxygen therapy use (low or high-flow oxygen) * Success rate in no intubation and/or mechanical ventilation * Success rate in non mortality occurrence

  Day 21

Secondary Outcomes (6)

• Symptomatic improve to estrogen therapy in non-severe COVID-19 patients

  Day 7

• Symptomatic improve to estrogen therapy in non-severe COVID-19 patients

  Day 14

• Symptomatic improve to estrogen therapy in non-severe COVID-19 patients

  Day 21

• Biochemical improve to estrogen therapy in non-severe COVID-19 patients

  Day 7

• Biochemical improve to estrogen therapy in non-severe COVID-19 patients

  Day 14

Study Arms (2)

Estrogen Therapy

EXPERIMENTAL

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)

Drug: Estrogen Therapy

Control Group

NO INTERVENTION

Patients who will receive conventional COVID-19 treatment

Interventions

Estrogen Therapy DRUG

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

Also known as: Norelgesetromin, Ethinyl estradiol

Estrogen Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CMN "20 de Noviembre": lead

Study Sites (1)

CMN "20 de Noviembre"

Mexico City, Benito Juárez, 03100, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Estrogen Replacement Therapy; Ethinyl Estradiol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormone Replacement Therapy; Drug Therapy; Therapeutics; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Rodrigo Ruz Barros, MD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Daniel Santillán Cortés, MSc

  CMN "20 de Noviembre"

  STUDY CHAIR

• Mónica Escamilla Tilch, PhD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Juan A Pineda Juárez, PhD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Sandra Muñoz López, MD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Maricela Escarela Serrano, MD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Paul Mondragón Terán, PhD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Alberto H De la Vega Bravo, MD

  CMN "20 de Noviembre"

  STUDY CHAIR

• Alfredo L Cortés Algara, MD, MSc

  CMN "20 de Noviembre"

  PRINCIPAL INVESTIGATOR

• Samuel Reyes-Long, MSc

  Neurociencias básicas, Instituto Nacional de Rehabilitación LGII

  STUDY CHAIR

• Cindy Bandala, MD MSc PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcome Assessor will be an external member of the Gynecology Service, which will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecology Service Member, MD, MSc

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2020
• Primary Completion: April 3, 2023
• Study Completion: December 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)