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Progesterone for the Treatment of COVID-19 in Hospitalized Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365127
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
IBSA Institut Biochimique SA
Information provided by (Responsible Party):
Sara Ghandehari, Cedars-Sinai Medical Center

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

Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV2 Drug: Progesterone 100 MG Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men
Actual Study Start Date : April 27, 2020
Actual Primary Completion Date : August 20, 2020
Actual Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Drug: Progesterone 100 MG
Subcutaneous administration twice daily
No Intervention: SOC only
Subjects will receive institutional standard of care only


Outcome Measures
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Primary Outcome Measures :
  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

    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


Secondary Outcome Measures :
  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

    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

  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365127


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90035
Sponsors and Collaborators
Sara Ghandehari
IBSA Institut Biochimique SA
Investigators
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Principal Investigator: Sara Ghandehari, MD Cedars-Sinai Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sara Ghandehari, Attending Physician, Internal Medicine/Pulmonary Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04365127    
Other Study ID Numbers: STUDY00000611
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs