Progesterone for the Treatment of COVID-19 in Hospitalized Men

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

Detailed Description
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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.

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

Conditions
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COVID-19, Sars-CoV2

Intervention / Treatment
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* Drug: Progesterone 100 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone plus SOC<br>Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care | Drug: Progesterone 100 MG<br>* Subcutaneous administration twice daily<br>|
| No Intervention: SOC only<br>Subjects will receive institutional standard of care only | |

What is the study measuring?
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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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |