• Sara Ghandehari, Yuri Matusov, Samuel Pepkowitz, Donald Stein, Tamana Kaderi, Divya Narayanan, Josephine Hwang, Stephanie Chang, Robert Goodman, Heli Ghandehari, James Mirocha, Catherine Bresee, Victor Tapson, and Michael Lewis.
• Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA. Electronic address: sara.ghandehari@cshs.org.
• Chest. 2021 Jul 1; 160 (1): 748474-84.

BackgroundSeverity 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 QuestionDoes short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19?Study Design And MethodsWe 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.ResultsForty-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.InterpretationProgesterone 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 RegistryClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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