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Progesterone in Addition to Standard of Care vs Standard of Care Alone in the Treatment of Men Hospitalized With Moderate to Severe COVID-19: A Randomized, Controlled Pilot Trial.
Ghandehari, Sara; Matusov, Yuri; Pepkowitz, Samuel; Stein, Donald; Kaderi, Tamana; Narayanan, Divya; Hwang, Josephine; Chang, Stephanie; Goodman, Robert; Ghandehari, Heli; Mirocha, James; Bresee, Catherine; Tapson, Victor; Lewis, Michael.
  • Ghandehari S; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA. Electronic address: sara.ghandehari@cshs.org.
  • Matusov Y; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Pepkowitz S; Department of Pathology and Laboratory Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Stein D; Department of Emergency Medicine, Emory University, Atlanta, GA.
  • Kaderi T; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Narayanan D; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Hwang J; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Chang S; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Goodman R; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Ghandehari H; independent biostatistical consultant, San Diego, CA.
  • Mirocha J; Biostatistics Core, Cedars Sinai Medical Center, Los Angeles, CA.
  • Bresee C; Biostatistics Core, Cedars Sinai Medical Center, Los Angeles, CA.
  • Tapson V; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
  • Lewis M; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
Chest ; 160(1): 74-84, 2021 07.
Article in English | MEDLINE | ID: covidwho-1258346
Semantic information from SemMedBD (by NLM)
1. progesterone TREATS Male population group
Subject
progesterone
Predicate
TREATS
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Male population group
2. COVID-19 PROCESS_OF Woman
Subject
COVID-19
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Woman
3. Therapeutic procedure TREATS Disease
Subject
Therapeutic procedure
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TREATS
Object
Disease
4. Patient in hospital PROCESS_OF Male population group
Subject
Patient in hospital
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PROCESS_OF
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Male population group
5. progesterone ADMINISTERED_TO Patients
Subject
progesterone
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ADMINISTERED_TO
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Patients
6. Day 7 PROCESS_OF Patients
Subject
Day 7
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PROCESS_OF
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Patients
7. progesterone NEG_CAUSES Serious Adverse Event
Subject
progesterone
Predicate
NEG_CAUSES
Object
Serious Adverse Event
8. progesterone TREATS Patients
Subject
progesterone
Predicate
TREATS
Object
Patients
9. Standard of Care TREATS Male population group
Subject
Standard of Care
Predicate
TREATS
Object
Male population group
10. progesterone TREATS Male population group
Subject
progesterone
Predicate
TREATS
Object
Male population group
11. COVID-19 PROCESS_OF Woman
Subject
COVID-19
Predicate
PROCESS_OF
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Woman
12. Therapeutic procedure TREATS Disease
Subject
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Disease
13. Patient in hospital PROCESS_OF Male population group
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PROCESS_OF
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Male population group
14. progesterone ADMINISTERED_TO Patients
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Subject
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Patients
16. progesterone NEG_CAUSES Serious Adverse Event
Subject
progesterone
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NEG_CAUSES
Object
Serious Adverse Event
17. progesterone TREATS Patients
Subject
progesterone
Predicate
TREATS
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Patients
18. Standard of Care TREATS Male population group
Subject
Standard of Care
Predicate
TREATS
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Male population group
ABSTRACT

BACKGROUND:

Severity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19. RESEARCH QUESTION Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19? STUDY DESIGN AND

METHODS:

We conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes.

RESULTS:

Forty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects.

INTERPRETATION:

Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19. TRIAL REGISTRY ClinicalTrials.gov; No. NCT04365127; URL www.clinicaltrials.gov.
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Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Progesterone / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Etiology study / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Humans / Male / Middle aged Language: English Journal: Chest Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Progesterone / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Etiology study / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Humans / Male / Middle aged Language: English Journal: Chest Year: 2021 Document Type: Article