Estrogen Therapy in Non-severe COVID-19 Patients

A study testing Estrogen Therapy in people with Covid-19, run by CMN "20 de Noviembre" at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Covid-19
What is being tested?: Estrogen Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteMexico
Study dates: 1 Oct 2020to 31 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

CMN "20 de Noviembre"
Mexico City, Benito Juárez, 03100

Other trials in Mexico

About this study

Official title: Estrogen Therapy in Non-severe COVID-19 Patients: Proposed Treatment Scheme in a Tertiary Hospital

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

Read the 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
Being tested: Estrogen Therapy
Keywords: COVID-19, Estrogens, Severe Acute Respiratory Syndrome Coronavirus-2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04539626
Study group	Role	What they receive
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) Receives: Drug: Estrogen Therapy
Control Group	No intervention	Patients who will receive conventional COVID-19 treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: Day 21

Secondary outcomes (6)

Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
According to the National Committee for Epidemiological Surveillance (CONAVE) in Mexico, COVID-19 symptomatic onset rate defined as the presence of cough, fever or headache during the last 7 days, accompanied at least one of the following symptoms: dyspnea, arthralgia, myalgia, odynophagia / pharyngeal burning, rhinorrhea, conjunctivitis or chest pain.
Measured: Day 7
Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
According to the National Committee for Epidemiological Surveillance (CONAVE) in Mexico, COVID-19 symptomatic onset rate defined as the presence of cough, fever or headache during the last 7 days, accompanied at least one of the following symptoms: dyspnea, arthralgia, myalgia, odynophagia / pharyngeal burning, rhinorrhea, conjunctivitis or chest pain.
Measured: Day 14
Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
According to the National Committee for Epidemiological Surveillance (CONAVE) in Mexico, COVID-19 symptomatic onset rate defined as the presence of cough, fever or headache during the last 7 days, accompanied at least one of the following symptoms: dyspnea, arthralgia, myalgia, odynophagia / pharyngeal burning, rhinorrhea, conjunctivitis or chest pain.
Measured: Day 21
Biochemical improve to estrogen therapy in non-severe COVID-19 patients
Percentage change from hemoglobin, hematocrit, leukocytes, erythrocytes, platelets, prothrombin, partial thromboplastin activation time, anti-thrombin activity, fibrinogen, fibrin degradation products, D-Dimer, ALT, AST, ALP, GGT, LD, albumin, cholesterol, triglycerides, HDL, LDL, C-reactive protein, estrogens and progesterone levels, pro inflammatory cytokine and nitric oxide profile.
Measured: Day 7
Biochemical improve to estrogen therapy in non-severe COVID-19 patients
Percentage change from hemoglobin, hematocrit, leukocytes, erythrocytes, platelets, prothrombin, partial thromboplastin activation time, anti-thrombin activity, fibrinogen, fibrin degradation products, D-Dimer, ALT, AST, ALP, GGT, LD, albumin, cholesterol, triglycerides, HDL, LDL, C-reactive protein, estrogens and progesterone levels, pro inflammatory cytokine and nitric oxide profile.
Measured: Day 14
Angiotensin 1-7 change after estrogen therapy in non-severe COVID-19 patientsCOVID-19 patients
Percentage change from Angiotensin 1-7, measured with the Human Angiotensin 1-7 ELISA kit (colorimetric) [pg/mL]
Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202031 Dec 2023

First posted7 Sep 2020
Study start1 Oct 2020
Primary completion3 Apr 2023
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04539626
Sponsor's protocol ID: 03
Status last verified: Apr 2023
First submitted: 3 Sep 2020
Last updated: 5 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Estrogen Therapy in Non-severe COVID-19 Patients: Proposed Treatment Scheme in a Tertiary Hospital
ClinicalTrials.gov ID: NCT04539626
Acronym / sponsor ID: 03
Conditions: Covid-19
Keywords: COVID-19, Estrogens, Severe Acute Respiratory Syndrome Coronavirus-2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 44 participants (actual)
Lead sponsor: CMN "20 de Noviembre"University, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 3 Apr 2023 (actual)
Study completion: 31 Dec 2023 (estimated)
First posted: 7 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Estrogen Therapy	Experimental	Drug: Estrogen TherapyDrug: 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)
Control Group	No intervention	–Patients who will receive conventional COVID-19 treatment

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Estrogen TherapyAlso: Norelgesetromin, Ethinyl estradiolEVRA skin patches with norelgesetromin 6mg / ethinyl estradiol 0.60mg, (1 patch will be placed every week during 21 days)	Drug	Estrogen Therapy

Primary outcome

Clinical improve to estrogen therapy in non-severe COVID-19 patients Clinical improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 7
* 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
Clinical improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 14
* 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
Clinical improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 21
* 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

6 secondary outcomes

Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 7
Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 14
Symptomatic improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 21
Biochemical improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 7
Biochemical improve to estrogen therapy in non-severe COVID-19 patients
Time frame: Day 14
Angiotensin 1-7 change after estrogen therapy in non-severe COVID-19 patientsCOVID-19 patients
Time frame: Day 21

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rodrigo Ruz Barros, MD study chair

CMN "20 de Noviembre"

Daniel Santillán Cortés, MSc study chair

CMN "20 de Noviembre"

Mónica Escamilla Tilch, PhD study chair

CMN "20 de Noviembre"

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Estrogen Therapy in people with Covid-19, run by CMN "20 de Noviembre" at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improve to estrogen therapy in non-severe COVID-19 patients Clinical improve to estrogen therapy in non-severe COVID-19 patients (time frame: Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04539626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.