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Role of female sex hormone in COVID 19 patients

Role of short term oral oestradiol in natural oestrogen deficient symptomatic COVID-19 patients-a Randomized Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027622
Enrollment
64
Registered
2020-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Estradiol valerate, standard care: Study group will receive Estradiol Valerate orally 2 mg once a day for 7 days along with standard care as an adjunctive therapy. Control group will r

Sponsors

Dr Shikha seth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Documented symptomatic(fever of 100.5°F or more or 38°C shortness of breath cough anosmia GI disturbances persisting myalgiaetc any one of them present).) COVID19 positive patients. 2.Male 18-60 years of age 3.Female 40-60 years of age with one year amenorrhoea. 4.Ready to participate and provide informed consent. 5.Patients enrolled shall not be the part of any other drug trial.

Exclusion criteria

Exclusion criteria: 1.Currently receiving estrogen based hormonal therapy 2.Abnormal genital bleeding 3.Subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer 4.Pre-existing liver impairment (e.g. Hepatitis C, cirrhosis),heart disease, Any history of thromboembolic event including deep vein thrombosis or pulmonary emboli , History of stroke. 5.Receiving anti epileptic therapy 6.Subjects with severe COVID disease. 7.Males on testosterone 8.Those on steroids for any of their disease 9.Patients enrolled in any other drug trial.

Design outcomes

Secondary

MeasureTime frame
ICU admissionTimepoint: during hospital stay;Any other adverse eventsTimepoint: during hospital stay;Change in Biochemical and inflammatory parametersTimepoint: during hospital stay;Change in Haematological parameterTimepoint: during hospital stay;Clinical progression to moderate/severe diseaseTimepoint: during hospital stay;MortalityTimepoint: during hospital stay;Re admission to hospitalTimepoint: within a month;Requirement of oxygen therapyTimepoint: during hospital stay;Requirement of special therapies – IL-6 inhibitor, low molecular weight heparin(LMWH) or plasma therapy. Timepoint: during hospital stay;Requirement of Ventilatory support ( non invasive or invasive)Timepoint: during hospital stay

Primary

MeasureTime frame
Total hospital stay durationTimepoint: number of days

Countries

India

Contacts

Public ContactDr Shikha Seth

Government institute of medical sciences greater Noida UP

drsethrims@gmail.com9411850238

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026