Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04365127
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progesterone for the Treatment of COVID-19 in Hospitalized Men
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': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale', 'timeFrame': '7 days', 'description': 'Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale\n\n1. Death\n2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)\n3. Hospitalized, on high flow oxygen devices\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, not requiring supplemental oxygen\n6. Not hospitalized, limitation on activities\n7. Not hospitalized, no limitations on activities'}], 'secondaryOutcomes': [{'measure': 'Change in clinical status of subjects assessed daily while hospitalized and on Day 15', 'timeFrame': '29 days', 'description': 'Change in clinical status of subjects daily while hospitalized and at Day 15 based on the following 7-point ordinal scale\n\n1. Death\n2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)\n3. Hospitalized, on high flow oxygen devices\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, not requiring supplemental oxygen\n6. Not hospitalized, limitation on activities\n7. Not hospitalized, no limitations on activities'}, {'measure': 'Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization', 'timeFrame': '15 days', 'description': 'The length of time that the subjects require supplemental oxygen.\n\nThe length of time that the subjects require mechanical ventilation (if applicable).\n\nThe length of time that the subjects remain in the hospital.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Sars-CoV2']}, 'referencesModule': {'references': [{'pmid': '28401937', 'type': 'BACKGROUND', 'citation': 'Hall OJ, Klein SL. Progesterone-based compounds affect immune responses and susceptibility to infections at diverse mucosal sites. Mucosal Immunol. 2017 Sep;10(5):1097-1107. doi: 10.1038/mi.2017.35. Epub 2017 Apr 12.'}, {'pmid': '21977998', 'type': 'BACKGROUND', 'citation': 'Menzies FM, Henriquez FL, Alexander J, Roberts CW. Selective inhibition and augmentation of alternative macrophage activation by progesterone. Immunology. 2011 Nov;134(3):281-91. doi: 10.1111/j.1365-2567.2011.03488.x.'}, {'pmid': '18373668', 'type': 'BACKGROUND', 'citation': 'Jones LA, Anthony JP, Henriquez FL, Lyons RE, Nickdel MB, Carter KC, Alexander J, Roberts CW. Toll-like receptor-4-mediated macrophage activation is differentially regulated by progesterone via the glucocorticoid and progesterone receptors. Immunology. 2008 Sep;125(1):59-69. doi: 10.1111/j.1365-2567.2008.02820.x. Epub 2008 Mar 28.'}, {'pmid': '27631986', 'type': 'BACKGROUND', 'citation': 'Hall OJ, Limjunyawong N, Vermillion MS, Robinson DP, Wohlgemuth N, Pekosz A, Mitzner W, Klein SL. Progesterone-Based Therapy Protects Against Influenza by Promoting Lung Repair and Recovery in Females. PLoS Pathog. 2016 Sep 15;12(9):e1005840. doi: 10.1371/journal.ppat.1005840. eCollection 2016 Sep.'}, {'pmid': '32292903', 'type': 'BACKGROUND', 'citation': "Breslin N, Baptiste C, Gyamfi-Bannerman C, Miller R, Martinez R, Bernstein K, Ring L, Landau R, Purisch S, Friedman AM, Fuchs K, Sutton D, Andrikopoulou M, Rupley D, Sheen JJ, Aubey J, Zork N, Moroz L, Mourad M, Wapner R, Simpson LL, D'Alton ME, Goffman D. Coronavirus disease 2019 infection among asymptomatic and symptomatic pregnant women: two weeks of confirmed presentations to an affiliated pair of New York City hospitals. Am J Obstet Gynecol MFM. 2020 May;2(2):100118. doi: 10.1016/j.ajogmf.2020.100118. Epub 2020 Apr 9."}, {'pmid': '26342177', 'type': 'BACKGROUND', 'citation': 'Cometti B. Pharmaceutical and clinical development of a novel progesterone formulation. Acta Obstet Gynecol Scand. 2015 Nov;94 Suppl 161:28-37. doi: 10.1111/aogs.12765.'}, {'pmid': '26991890', 'type': 'BACKGROUND', 'citation': 'Doblinger J, Cometti B, Trevisan S, Griesinger G. Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials. PLoS One. 2016 Mar 18;11(3):e0151388. doi: 10.1371/journal.pone.0151388. eCollection 2016.'}, {'pmid': '32217556', 'type': 'BACKGROUND', 'citation': 'Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091.'}, {'pmid': '33621601', 'type': 'DERIVED', 'citation': 'Ghandehari S, Matusov Y, Pepkowitz S, Stein D, Kaderi T, Narayanan D, Hwang J, Chang S, Goodman R, Ghandehari H, Mirocha J, Bresee C, Tapson V, Lewis M. Progesterone in Addition to Standard of Care vs Standard of Care Alone in the Treatment of Men Hospitalized With Moderate to Severe COVID-19: A Randomized, Controlled Pilot Trial. Chest. 2021 Jul;160(1):74-84. doi: 10.1016/j.chest.2021.02.024. Epub 2021 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.', 'detailedDescription': 'Hospitalized men with COVID-19 who meet the eligibility criteria will be informed about study and the potential risks. All the patients giving written informed consent will be randomized in 1:1 ratio to progesterone (100 mg SQ twice daily) plus standard of care or standard of care alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Laboratory-confirmed COVID-19 with in 72 hours prior to randomization\n2. Respiratory symptoms or abnormal lung exam or abnormal chest imaging AND oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow\n3. Understands and agrees to comply with planned study procedures\n4. Agrees to the collection of venous blood per protocol\n5. Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized\n\nExclusion Criteria:\n\n1. ALT or AST \\>5 times the upper limit of normal\n2. History of blood clots\n3. History of breast cancer\n4. Allergy to progesterone or betacyclodextrin\n5. Use of supplemental oxygen prior to hospital admission\n6. Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT04365127', 'briefTitle': 'Progesterone for the Treatment of COVID-19 in Hospitalized Men', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men', 'orgStudyIdInfo': {'id': 'STUDY00000611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progesterone plus SOC', 'description': 'Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care', 'interventionNames': ['Drug: Progesterone 100 MG']}, {'type': 'NO_INTERVENTION', 'label': 'SOC only', 'description': 'Subjects will receive institutional standard of care only'}], 'interventions': [{'name': 'Progesterone 100 MG', 'type': 'DRUG', 'description': 'Subcutaneous administration twice daily', 'armGroupLabels': ['Progesterone plus SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Sara Ghandehari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sara Ghandehari', 'class': 'OTHER'}, 'collaborators': [{'name': 'IBSA Institut Biochimique SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Internal Medicine/Pulmonary Medicine', 'investigatorFullName': 'Sara Ghandehari', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}