Clinical trials suggest that injections of female sex hormones may reduce the severity of the disease in certain male patients-ScienceDaily

A pilot clinical trial of 40 men is believed to be the first published study to use progesterone to treat male COVID-19 patients with coronavirus-induced pulmonary dysfunction. While the findings are promising, researchers say larger clinical trials are needed to establish the potential for this treatment.

According to Sarah Gandehari, MD, director and principal investigator of the Women’s Guild Lung Institute in Cedars Sinai, the study found that men were at greater risk of COVID-19 death and serious illness than women. Prompted by multiple reports of high. For the trial.

“As an ICU doctor, I was very ill and was impressed by the gender differences in COVID-19 patients who remained in the hospital and needed mechanical ventilation,” she said. In addition, several published studies have shown that premenopausal women with high progesterone levels generally have less severe COVID-19 disease than postmenopausal women with low progesterone levels. While both male and female bodies naturally produce progesterone, females produce far more hormones during the reproductive year.

Protective effect from female hormones

Gandehari hypothesized that gender differences in the consequences of the disease may be due in part to the protective effects of female hormones. In particular, preclinical studies elsewhere have pointed out that progesterone has certain anti-inflammatory properties. This finding may help progesterone weaken the sometimes deadly immune response known as a “cytokine storm” that can exacerbate lung damage in COVID-19 patients and attack other organs. Suggested that there is.

In the Cedars-Sinai clinical trial, conducted April-August 2020, 40 male patients admitted with moderate to severe COVID-19 were randomly assigned to one of two groups. Patients in the control group received standard medical care at the time of illness. Patients in the group received 100 milligrams of progesterone twice daily for 5 days in addition to standard treatment during hospitalization. Both groups were evaluated daily for 15 days or until discharge.

research result

The study showed that patients in the progesterone-treated group scored a median 1.5 points higher on a standard 7-point scale of clinical status after 7 days compared to the control group. Scales ranged from a maximum of 7 (“not hospitalized, unlimited activity”) to 1 (“death”). The progesterone group had lower hospital stays overall and less need for oxygen supplementation and mechanical ventilation, but the differences between the two groups in these particular categories were not statistically significant.

There were no serious adverse events, including life-threatening events, resulting from progesterone administration. During the 15-day study period, there were a total of two deaths, one in each group, neither of which was due to progesterone.

“Our findings encourage the possibility of using progesterone to treat men with COVID-19, but our study had significant limitations,” Ghandehari said. I will.

She said the sample size was relatively small, involving primarily Caucasian, Hispanic, and obese patients, with a moderate burden of comorbidities and a high risk of worsening results. In addition, clinical trials were randomized and controlled, but not blinded. That is, researchers, patients, and treating physicians knew who received the treatment.

“To establish the degree of clinical efficacy and assess other potential safety concerns of this treatment approach in a larger, more heterogeneous population, including postmenopausal women and other treatment centers. Further research is needed, “said Gandehari, assistant director, of the lung transplant program at Cedars-Sinai.

Progesterone has been approved by the US Food and Drug Administration (FDA) for use in conditions related to female fertility, but not for immunologically regulated inflammatory responses. The FDA has approved this special use for the purposes of Cedars-Sinai clinical trials under the application of new drugs in clinical trials.

In addition to several Cedars-Sinai researchers, the study was attended by Donald Stein, PhD of Emory University in Atlanta, and Heli Ghandehari, an independent biostatistics consultant in San Diego.