Oestrogen Treatment for COVID-19 Symptoms

COVID-19 Clinical Trial

Official title:

The Impact of Oestrogen Administration on Covid-19 Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04853069
• Other study ID #: MRC-05-099
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 17, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2021
• Source: Hamad Medical Corporation
• Contact: Michael P Frenneaux
• Phone: 0097455425733
• Email: MFrenneaux[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)

• Adult males > 18 years of age OR

• Post-menopausal women (spontaneous amenorrhoea for >12 months in the absence of any other cause)

Exclusion Criteria:

Women:

• taking oestrogen supplements or oestrogen receptor antagonists

• with abnormal genital bleeding

• with a history of breast cancer

• with a history of endometrial or ovarian cancer

• with untreated endometrial hyperplasia

Men:

• taking hormone therapies (e.g. for prostate cancer)

Any subject:

• failure to obtain consent

• taking lamotrigine

• with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)

• with pre-existing liver or renal disease

• with known allergy to exogenous oestrogens

• with a history of porphyria

• with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli

• taking part in another interventional clinical trial

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (2)

Lead Sponsor	Collaborator
Hamad Medical Corporation	Laboratoires Besins International

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of disease progression for mild cases	Proportion hospitalised within 28 days	28 days
Primary	Evidence of disease progression in hospitalised patients (moderate and severe cases)	Proportion requiring mechanical ventilation or dying within 28 days	28 days
Secondary	Hospital mortality	Rate of mortality	28 days
Secondary	Duration of hospital admission	Length of stay at hospital	28 days
Secondary	Admission to ICU/ HDU facility	Length of stay at ICU/HDU facility	28 days
Secondary	Need for renal replacement therapy	Proportion requiring renal replacement therapy	28 days
Secondary	Ventilation	Proportion requiring mechanical ventilation within 28 days	28 days
Secondary	Time to being fit for hospital discharge	Time of discharge	28 days