Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT05774405
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of disease progression for mild cases', 'timeFrame': '15 days', 'description': 'Proportion of patients who are hospitalised in 15 days'}, {'measure': 'Evidence of disease progression for moderate and severe cases', 'timeFrame': '15 days', 'description': 'Proportion of patients who required mechanical ventilation or died within 15 days'}, {'measure': 'Kidney function tests', 'timeFrame': '15 days', 'description': 'change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application'}, {'measure': 'Platelet', 'timeFrame': '15 days', 'description': 'change of platelets in total blood count (\\*10\\^3/μL) with estrogen and hydrogel patch application'}, {'measure': 'Markers of coagulation', 'timeFrame': '15 days', 'description': 'change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application'}, {'measure': 'Marker of inflammation', 'timeFrame': '15 days', 'description': 'change of C-reactive protein (mg/L) levels within 15 days'}], 'secondaryOutcomes': [{'measure': 'serum E2 levels', 'timeFrame': '15 days', 'description': 'change of serum E2 levels with estrogen and hydrogel patch application'}, {'measure': 'rate of death', 'timeFrame': '15 days', 'description': 'comparison of rate of death in each arm'}, {'measure': 'rate of complications', 'timeFrame': '15 days', 'description': 'comparison of rate of complications in each arm'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'hormone replacement therapy'], 'conditions': ['COVID-19', 'Hormone Replacement Therapy']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease.\n\nThe main question\\[s\\] it aims to answer are:\n\n* the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease\n* the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease\n\nAll participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.\n\nAs an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.\n\nResearchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease', 'detailedDescription': 'The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, morbidity and mortality from Covid-19 disease were higher among men compared to women. This is caused by the differences in immunological response and viral pathogenesis between men and women. It is theoretically assumed that estrogen has a positive impact on female COVID-19 patients. In this randomized placebo-controlled study, we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease. Female patients diagnosed with Covid-19 disease were examined and only postmenopausal women were included into the study. The COVID-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs. All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.\n\nAs an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.\n\nOur primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease. The epidemiological and clinical data, the results of biochemical analysis, the information regarding the treatment and outcomes and serum estradiol levels were determined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients diagnosed with Covid-19 disease\n* Postmenopausal women (who had 12 months of amenorrhea after their final menstrual period)\n* Positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs\n\nExclusion Criteria:\n\n* Negative RT-PCR test\n* Female patients at reproductive stage'}, 'identificationModule': {'nctId': 'NCT05774405', 'briefTitle': 'Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '68871907-604.01.01-67414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Estradiol patch (Climara 7.8 mg patch/week, Bayer, Germany) for 14 days.', 'interventionNames': ['Drug: Climara 0.1Mg/24Hr Transdermal System']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Hydrogel patch (Adhesive Hydrogel patch/week, Rebul Pharmacy, Turkey) for 14 days.', 'interventionNames': ['Other: Hydrogel patch']}], 'interventions': [{'name': 'Climara 0.1Mg/24Hr Transdermal System', 'type': 'DRUG', 'description': 'Transdermal estradiol patch is used.', 'armGroupLabels': ['Experimental']}, {'name': 'Hydrogel patch', 'type': 'OTHER', 'description': 'Adhesive Hydrogel patch', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Cemal Tamer Erel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turkish Menopause and Osteoporosis Society', 'class': 'UNKNOWN'}, {'name': 'Karakoy Rotary Club', 'class': 'UNKNOWN'}, {'name': 'Rebul Pharmacy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Cemal Tamer Erel', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}