- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04365127
Progesterone for the Treatment of COVID-19 in Hospitalized Men
A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90035
- Cedars Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
- 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
- Understands and agrees to comply with planned study procedures
- Agrees to the collection of venous blood per protocol
- Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized
Exclusion Criteria:
- ALT or AST >5 times the upper limit of normal
- History of blood clots
- History of breast cancer
- Allergy to progesterone or betacyclodextrin
- Use of supplemental oxygen prior to hospital admission
- Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Progesterone plus SOC
Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care
|
Subcutaneous administration twice daily
|
No Intervention: SOC only
Subjects will receive institutional standard of care only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale
Time Frame: 7 days
|
Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinical status of subjects assessed daily while hospitalized and on Day 15
Time Frame: 29 days
|
Change in clinical status of subjects daily while hospitalized and at Day 15 based on the following 7-point ordinal scale
|
29 days
|
Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization
Time Frame: 15 days
|
The length of time that the subjects require supplemental oxygen. The length of time that the subjects require mechanical ventilation (if applicable). The length of time that the subjects remain in the hospital. |
15 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Ghandehari, MD, Cedars-Sinai Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: BMJ. 2020 Mar 31;368:m1295.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Progestins
- Progesterone
Other Study ID Numbers
- STUDY00000611
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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