Progesterone for the Treatment of COVID-19 in Hospitalized Men

January 25, 2021 updated by: Sara Ghandehari

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90035
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 7 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical status of subjects assessed daily while hospitalized and on Day 15
Time Frame: 29 days

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
29 days
Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization
Time Frame: 15 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sara Ghandehari, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

August 20, 2020

Study Completion (Actual)

August 20, 2020

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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