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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

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE April 27, 2020
Actual Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progesterone for the Treatment of COVID-19 in Hospitalized Men
Official Title  ICMJE A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men
Brief Summary The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Sars-CoV2
Intervention  ICMJE Drug: Progesterone 100 MG
Subcutaneous administration twice daily
Study Arms  ICMJE
  • Experimental: Progesterone plus SOC
    Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care
    Intervention: Drug: Progesterone 100 MG
  • No Intervention: SOC only
    Subjects will receive institutional standard of care only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 20, 2020
Actual Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365127
Other Study ID Numbers  ICMJE STUDY00000611
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sara Ghandehari, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Sara Ghandehari
Collaborators  ICMJE IBSA Institut Biochimique SA
Investigators  ICMJE
Principal Investigator: Sara Ghandehari, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP