COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46908

Dr Shikha Seth

drsethrims@gmail.com

2020-09-07

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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. <br/ >2.Male 18-60 years of age <br/ >3.Female 40-60 years of age with one year amenorrhoea. <br/ >4.Ready to participate and provide informed consent. <br/ >5.Patients enrolled shall not be the part of any other drug trial. <br/ > <br/ >

1.Currently receiving estrogen based hormonal therapy <br/ >2.Abnormal genital bleeding <br/ >3.Subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer <br/ >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. <br/ >5.Receiving anti epileptic therapy <br/ >6.Subjects with severe COVID disease. <br/ >7.Males on testosterone <br/ >8.Those on steroids for any of their disease <br/ >9.Patients enrolled in any other drug trial. <br/ >

2

Dr Shikha seth

18

60

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

64

Total hospital stay durationTimepoint: number of days

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 482, "treatment_name": "Estradiol", "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"}]