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NCT04365127

Progesterone for the Treatment of COVID-19 in Hospitalized Men

Completed Phase 1 Last updated 27 January 2021
What this trial tests

Phase 1 trial testing Progesterone 100 MG in COVID-19 in 40 participants. Completed in 20 August 2020.

Timeline
27 April 2020
Primary endpoint
20 August 2020
20 August 2020

Quick facts

Lead sponsorSara Ghandehari
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date27 April 2020
Primary completion20 August 2020
Estimated completion20 August 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sara Ghandehari — full company profile →

Who can join

18 and older, male only, with COVID-19 or Sars-CoV2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
    Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
  2. Estradiol, Progesterone, Immunomodulation, and COVID-19 Outcomes.
    Mauvais-Jarvis F, Klein SL, Levin ER. · · 2020 · cited 177× · PMID 32730568 · DOI 10.1210/endocr/bqaa127
  3. Androgen sensitivity gateway to COVID-19 disease severity.
    Wambier CG, Goren A, Vaño-Galván S, Ramos PM, et al · · 2020 · cited 107× · PMID 32412125 · DOI 10.1002/ddr.21688
  4. ACE2: the molecular doorway to SARS-CoV-2.
    Medina-Enríquez MM, Lopez-León S, Carlos-Escalante JA, Aponte-Torres Z, et al · · 2020 · cited 81× · PMID 33380340 · DOI 10.1186/s13578-020-00519-8
  5. A multi-pronged approach targeting SARS-CoV-2 proteins using ultra-large virtual screening.
    Gorgulla C, Padmanabha Das KM, Leigh KE, Cespugli M, et al · · 2021 · cited 72× · PMID 33426509 · DOI 10.1016/j.isci.2020.102021
  6. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  7. Sex-related differences in COVID-19 lethality.
    Penna C, Mercurio V, Tocchetti CG, Pagliaro P. · · 2020 · cited 66× · PMID 32698249 · DOI 10.1111/bph.15207
  8. Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives.
    Sarkar C, Mondal M, Torequl Islam M, Martorell M, et al · · 2020 · cited 64× · PMID 33041814 · DOI 10.3389/fphar.2020.572870

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