Clinical trial suggests injections of female hormone may reduce disease severity in certain male patients — ScienceDaily

The pilot scientific trial, involving 40 males, is believed to be the primary printed examine to make use of progesterone to deal with male COVID-19 sufferers whose lung capabilities have been compromised by the coronavirus. Whereas the findings are promising, bigger scientific trials are wanted to ascertain the potential of this experimental remedy, the investigators mentioned.

The examine was prompted by a number of experiences that males are at greater threat of mortality and extreme sickness from COVID-19 than are ladies, in keeping with Sara Ghandehari, MD, director of Pulmonary Rehabilitation within the Ladies’s Guild Lung Institute at Cedars-Sinai and principal investigator for the trial.

“As an ICU physician, I used to be struck by the gender disparity amongst COVID-19 sufferers who have been very sick, remained within the hospital and wanted ventilators,” she mentioned. As well as, some printed analysis had indicated that premenopausal ladies, who usually have greater progesterone ranges, had much less extreme COVID-19 illness than did postmenopausal ladies, who’ve decrease progesterone ranges. Whereas the our bodies of each women and men naturally produce progesterone, ladies produce rather more of the hormone throughout their reproductive years.

Protecting Impact from Feminine Hormones

Ghandehari hypothesized that the gender variations in illness outcomes is perhaps due, partly, to a protecting impact from feminine hormones. Specifically, preclinical research elsewhere had pointed to progesterone as having sure anti-inflammatory properties. This discovering recommended progesterone is perhaps helpful in dampening a sometimes-fatal immune response, often known as a “cytokine storm,” that may worsen lung injury and assault different organs in COVID-19 sufferers.

For the Cedars-Sinai scientific trial, performed from April via August 2020, 40 male sufferers who have been hospitalized with reasonable to extreme COVID-19 have been randomly assigned to one in all two teams. Sufferers within the management group acquired the usual medical care on the time for the illness. Sufferers within the experimental group acquired customary care plus twice-daily injections of 100 milligrams of progesterone for 5 days whereas they have been hospitalized. Each teams have been assessed day by day for 15 days or till they have been discharged from the hospital.

Research Outcomes

The examine confirmed that, in contrast with the management group, sufferers within the group handled with progesterone scored a median 1.5 factors greater on a normal seven-point scale of scientific standing after seven days. The dimensions ranged from a excessive of seven (“not hospitalized, no limitations on actions”) to 1 (“dying”). Though the progesterone group total additionally had fewer days of hospitalization and a decrease want for supplemental oxygen and mechanical air flow, the variations between the 2 teams in these particular classes weren’t statistically important.

There have been no critical opposed occasions, together with life-threatening occasions, attributable to progesterone administration. There have been two deaths, one in every group, in the course of the15-day examine interval, neither of which was attributable to progesterone.

“Whereas our findings are encouraging for the potential of utilizing progesterone to deal with males with COVID-19, our examine had important limitations,” Ghandehari mentioned.

She famous the pattern measurement was comparatively small and concerned primarily white, Hispanic and overweight sufferers with a reasonable burden of comorbidities, which enhance the chance for worse outcomes. Additional, though the scientific trial was randomized and managed, it was unblinded — which means that the investigators, the sufferers and the treating physicians knew who acquired the experimental therapy.

“Additional analysis is important in bigger, extra heterogeneous populations, together with postmenopausal ladies and at different therapy facilities, to ascertain the diploma of scientific efficacy and to evaluate another potential security considerations of this therapy method,” mentioned Ghandehari, who is also assistant director of the Lung Transplant Program at Cedars-Sinai.

Progesterone is authorized by the U.S. Meals and Drug Administration (FDA) to be used in fertility-related situations in ladies however not for the modulation of immunologic-based, inflammatory responses. The FDA allowed this particular use for the aim of the Cedars-Sinai scientific trial underneath an investigational new drug utility.

Along with a number of Cedars-Sinai investigators, this examine concerned Donald Stein, PhD, from Emory College in Atlanta, and Heli Ghandehari, an unbiased biostatistical guide from San Diego.