Progesterone for the Treatment of COVID-19 in Hospitalized Men

COVID-19 Clinical Trial

Official title:

A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365127
• Other study ID #: STUDY00000611
• Status: Completed
• Phase: Phase 1
• Start date: April 27, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: January 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Laboratory-confirmed COVID-19 with in 72 hours prior to randomization

2. 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

3. Understands and agrees to comply with planned study procedures

4. Agrees to the collection of venous blood per protocol

5. Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized

Exclusion Criteria:

1. ALT or AST >5 times the upper limit of normal

2. History of blood clots

3. History of breast cancer

4. Allergy to progesterone or betacyclodextrin

5. Use of supplemental oxygen prior to hospital admission

6. Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2

Intervention

Drug:
• Progesterone 100 MG
Subcutaneous administration twice daily

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Sara Ghandehari	IBSA Institut Biochimique SA

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. Erratum in: BMJ. 2020 Mar 31;368:m1295. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale	Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale; Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities; Not hospitalized, no limitations on activities	7 days
Secondary	Change in clinical status of subjects assessed daily while hospitalized and on Day 15	Change in clinical status of subjects daily while hospitalized and at Day 15 based on the following 7-point ordinal scale; Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities; Not hospitalized, no limitations on activities	29 days
Secondary	Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization	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