Progesterone for the Treatment of COVID-19 in Hospitalized Men

Sara Ghandehari40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Sars-CoV2

Interventions

Progesterone 100 MGDRUG

Subcutaneous administration twice daily

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Time frame: 7 days

Secondary Outcomes

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 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

Time frame: 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.

Time frame: 15 days

Data from ClinicalTrials.gov

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