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Completed

NCT Number: NCT04365127

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90035, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone 100 MG

Drug

Subcutaneous administration twice daily

Primary outcomes

  1. 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

    • 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 outcomes

  1. 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

    • 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Sara Ghandehari

Other

Collaborators

  • IBSA Institut Biochimique SA

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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