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Progesterone for the Treatment of COVID-19 in Hospitalized Men

Primary Purpose

COVID-19, Sars-CoV2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Progesterone 100 MG

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Progesterone plus SOC

SOC only

Arm Description

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

Subjects will receive institutional standard of care only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT04365127

First Posted

April 24, 2020

Last Updated

January 25, 2021

Sponsor

Sara Ghandehari

Collaborators

IBSA Institut Biochimique SA

1. Study Identification

Unique Protocol Identification Number

NCT04365127

Brief Title

Progesterone for the Treatment of COVID-19 in Hospitalized Men

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 27, 2020 (Actual)

Primary Completion Date

August 20, 2020 (Actual)

Study Completion Date

August 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sara Ghandehari

Collaborators

IBSA Institut Biochimique SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Sars-CoV2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Progesterone plus SOC

Arm Type

Experimental

Arm Description

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

Arm Title

SOC only

Arm Type

No Intervention

Arm Description

Subjects will receive institutional standard of care only

Intervention Type

Drug

Intervention Name(s)

Progesterone 100 MG

Intervention Description

Subcutaneous administration twice daily

Primary Outcome Measure Information:

Title

Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale

Description

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

29 days

Title

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

Description

Time Frame

15 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Ghandehari, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90035

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28401937

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.

Results Reference

background

PubMed Identifier

21977998

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.

Results Reference

background

PubMed Identifier

18373668

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.

Results Reference

background

PubMed Identifier

27631986

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.

Results Reference

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PubMed Identifier

32292903

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.

Results Reference

background

PubMed Identifier

26342177

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.

Results Reference

background

PubMed Identifier

26991890

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.

Results Reference

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PubMed Identifier

32217556

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.

Results Reference

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PubMed Identifier

33621601

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.

Results Reference

derived

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Progesterone for the Treatment of COVID-19 in Hospitalized Men

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