NCT04853069

Oestrogen Treatment for COVID-19 Symptoms

The Impact of Oestrogen Administration on Covid-19 Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.

Detailed description

It is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) Oestrogen protects rodents from SARS-CoV-1 related mortality (iii) Women are relatively protected from developing or dying from severe COVID-19 and (iv) Postmenopausal women taking oestrogen replacement appear less likely to suffer Covid19-related critical illness. These effects may be mediated through oestrogen-related immunomodulation. In addition, however, 17β estradiol reduces expression of ACE2 (the receptor protein through which SARS-CoV-2 gains cellular entry) in tissues such as the kidney. As such, supplemental oestrogen may represent an effective therapy for Covid19. We will randomise adult men and postmenopausal women with confirmed Covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). The primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. Secondary outcomes will include hospital mortality, duration of hospital admission, admission to ICU/ HDU facility, ICU/ HDU length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge .

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Transdermal estradiol gel	Patients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days.

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-02-28
• Completion: 2022-03-31
• First posted: 2021-04-21
• Last updated: 2021-04-21

Locations

1 site across 1 country: Qatar