Progesterone for the Treatment of COVID-19 in Hospitalized Men

NCT04365127 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00000611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• 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 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Not hospitalized, limitation on activities 7. Not hospitalized, no limitations on activities

  7 days

Secondary Outcomes (2)

• Change in clinical status of subjects assessed daily while hospitalized and on Day 15

  29 days

• Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization

  15 days

Study Arms (2)

Progesterone plus SOC

EXPERIMENTAL

Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care

Drug: Progesterone 100 MG

SOC only

NO INTERVENTION

Subjects will receive institutional standard of care only

Interventions

Progesterone 100 MG DRUG

Subcutaneous administration twice daily

Progesterone plus SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Ghandehari: lead
• IBSA Institut Biochimique SA: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90035, United States

Location

Related Publications (9)

• 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: 28401937 BACKGROUND

• 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: 21977998 BACKGROUND

• 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: 18373668 BACKGROUND

• 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: 27631986 BACKGROUND

• 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: 32292903 BACKGROUND

• 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: 26342177 BACKGROUND

• 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: 26991890 BACKGROUND

• 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: 32217556 BACKGROUND

• 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.

  PMID: 33621601 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Sara Ghandehari, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Internal Medicine/Pulmonary Medicine

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: April 27, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)