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| Column | Value |
|---|---|
| Trial registration number | NCT04539626 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-09-07 |
|
Recruitment status
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
CMN "20 de Noviembre" |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
70 |
|
Countries
Last imported at : March 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mexico |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
44 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Clinical improve to estrogen therapy in non-severe COVID-19 patients Clinical improve to estrogen therapy in non-severe COVID-19 patients;Clinical improve to estrogen therapy in non-severe COVID-19 patients;Clinical improve to estrogen therapy in non-severe COVID-19 patients |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2262, "treatment_name": "Ethinyl estradiol+norelgesetromin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |