Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04853069
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oestrogen Treatment for COVID-19 Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label, randomized controlled trial, with patients randomized 1:1 to usual care, or usual care + oestrogen therapy.\n\nPrior to enrolment, an online CRF will be completed which will confirm that the patient meets the inclusion and exclusion criteria. Randomisation will be undertaken by the statistician in Qatar. Separate randomisation codes will be allocated for patients in Qatar and those in India, and separate randomisation will be performed for males and females. Randomisation will be enclosed in sequentially numbered sealed envelopes (with separate envelopes for males and females). Patients will be allocated to either the treatment or control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of disease progression for mild cases', 'timeFrame': '28 days', 'description': 'Proportion hospitalised within 28 days'}, {'measure': 'Evidence of disease progression in hospitalised patients (moderate and severe cases)', 'timeFrame': '28 days', 'description': 'Proportion requiring mechanical ventilation or dying within 28 days'}], 'secondaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': '28 days', 'description': 'Rate of mortality'}, {'measure': 'Duration of hospital admission', 'timeFrame': '28 days', 'description': 'Length of stay at hospital'}, {'measure': 'Admission to ICU/ HDU facility', 'timeFrame': '28 days', 'description': 'Length of stay at ICU/HDU facility'}, {'measure': 'Need for renal replacement therapy', 'timeFrame': '28 days', 'description': 'Proportion requiring renal replacement therapy'}, {'measure': 'Ventilation', 'timeFrame': '28 days', 'description': 'Proportion requiring mechanical ventilation within 28 days'}, {'measure': 'Time to being fit for hospital discharge', 'timeFrame': '28 days', 'description': 'Time of discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Oestrogen'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.', 'detailedDescription': '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.\n\nWe 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\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)\n* Adult males \\> 18 years of age OR\n* Post-menopausal women (spontaneous amenorrhoea for \\>12 months in the absence of any other cause)\n\nExclusion Criteria:\n\nWomen:\n\n* taking oestrogen supplements or oestrogen receptor antagonists\n* with abnormal genital bleeding\n* with a history of breast cancer\n* with a history of endometrial or ovarian cancer\n* with untreated endometrial hyperplasia\n\nMen:\n\n• taking hormone therapies (e.g. for prostate cancer)\n\nAny subject:\n\n* failure to obtain consent\n* taking lamotrigine\n* with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)\n* with pre-existing liver or renal disease\n* with known allergy to exogenous oestrogens\n* with a history of porphyria\n* with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli\n* taking part in another interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT04853069', 'briefTitle': 'Oestrogen Treatment for COVID-19 Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'The Impact of Oestrogen Administration on Covid-19 Disease', 'orgStudyIdInfo': {'id': 'MRC-05-099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oestrogen Therapy', 'description': 'Patients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days.', 'interventionNames': ['Drug: Transdermal estradiol gel']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients will receive only standard care.'}], 'interventions': [{'name': 'Transdermal estradiol gel', 'type': 'DRUG', 'otherNames': ['oestrogel', 'estrogel'], 'description': 'Patients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days.', 'armGroupLabels': ['Oestrogen Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 3050', 'city': 'Doha', 'country': 'Qatar', 'contacts': [{'name': 'Adel Ganaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael P Frenneaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Melanie Madhani, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hugh Montgomery, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Moad Ehfeda, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ali Omrani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muna Almaslamani, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hamad Medical Corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'centralContacts': [{'name': 'Michael P Frenneaux', 'role': 'CONTACT', 'email': 'MFrenneaux@hamad.qa', 'phone': '0097455425733'}, {'name': 'Adel Ganaw', 'role': 'CONTACT', 'email': 'aganaw@hamad.qa', 'phone': '0097433606110'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Laboratoires Besins International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}