Role of female sex hormone in COVID 19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027622
- Lead Sponsor
- Dr Shikha seth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total hospital stay durationTimepoint: number of days
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>weight heparin(LMWH) or plasma therapy. <br/ ><br>Timepoint: during hospital stay;Requirement of Ventilatory support ( non invasive or invasive)Timepoint: during hospital stay