Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.
Chest. 2021 Jul;160(1):74-84. doi: 10.1016/j.chest.2021.02.024. Epub 2021 Feb 20.
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.
Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19?
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.
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.
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.
ClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.
COVID-19 患者的病情严重程度在女性中普遍较低。关注性别这一生物学因素，可能为该疾病提供潜在的治疗干预手段。我们评估了在接受标准治疗（SOC）的基础上添加孕激素是否会改善中重度 COVID-19 住院男性的临床结局。
短期皮下给予孕激素是否能安全改善住院合并低氧血症的 COVID-19 男性患者的临床结局？
我们开展了一项针对住院合并确诊中重度 COVID-19 的男性患者的孕激素皮下给药的试点、随机、开放标签、对照试验。患者被随机分配接受 SOC 加孕激素（100mg 皮下每日 2 次，最多 5 天）或 SOC 单药治疗。除了评估安全性外，主要结局为第 7 天临床状态的变化。住院时间和补充氧气天数为关键次要结局。
2020 年 4 月至 8 月期间共纳入 42 例患者；其中 22 例被随机分配至对照组，20 例被分配至孕激素组。孕激素组有 2 例患者在接受孕激素前退出研究。与对照组相比，孕激素组患者的总体临床状态评分中位数在 7 分制量表上从基线到第 7 天改善了 1.5 分（95%CI，0.0-2.0；P=0.024）。没有与孕激素相关的严重不良事件。与对照组相比，接受孕激素治疗的患者需要补充氧气的天数减少 3 天（中位数，4.5 天 vs 7.5 天），住院时间减少 2.5 天（中位数，7.0 天 vs 9.5 天）。
在 SOC 的基础上，每日 2 次、皮下给予 100mg 孕激素可能是治疗中重度 COVID-19 合并低氧血症男性患者的一种安全有效的方法。
ClinicalTrials.gov；编号：NCT04365127；网址：www.clinicaltrials.gov。
