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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365127
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
IBSA Institut Biochimique SA
Information provided by (Responsible Party):
Sara Ghandehari, Cedars-Sinai Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 27, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : April 17, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in clinical status of subjects at Day 15 based on the following 7-point ordinal scale [ Time Frame: 15 days ]

    Change in clinical status of subjects 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


Secondary Outcome Measures :
  1. Change in clinical status of subjects assessed daily while hospitalized and on Day 29 [ Time Frame: 29 days ]

    Change in clinical status of subjects daily while hospitalized and at Day 29 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: 29 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. ≥ Stage 4 severe chronic kidney disease or requiring dialysis
  3. History of blood clots
  4. History of breast cancer
  5. Allergy to progesterone or betacyclodextrin
  6. Use of supplemental oxygen prior to hospital admission
  7. Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation

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


Contacts
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Contact: Vanessa Vasco 3109677451 Vanessa.Vasco@csmns.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90035
Contact    310-423-5000      
Principal Investigator: Sara Ghandehari, MD         
Sponsors and Collaborators
Sara Ghandehari
IBSA Institut Biochimique SA
Investigators
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Principal Investigator: Sara Ghandehari, MD Cedars-Sinai Medical Center
Publications:

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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: April 28, 2020
Last Verified: April 2020

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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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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs