Status:
UNKNOWN
Oestrogen Treatment for COVID-19 Symptoms
Lead Sponsor:
Hamad Medical Corporation
Collaborating Sponsors:
Laboratoires Besins International
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 rel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04853069
Start Date
May 17 2021
End Date
March 31 2022
Last Update
April 21 2021
Active Locations (1)
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1
Hamad Medical Corporation
Doha, Qatar, PO Box 3050