The results of a major US pilot trial – conducted with the help of IBSA and recently published in the prestigious international journal Chest – are encouraging. The results confirm the protective role of a subcutaneous formulation of progesterone in male patients with COVID-19.
The trial was conducted by researchers at the Cedars-Sinai Medical Center in Los Angeles with the collaboration of IBSA, a leading manufacturer of subcutaneous progesterone for infertility treatment. IBSA teamed up with Californian university UCLA and the Cedars-Sinai team, providing the hormone required for the clinical trial, following authorisation from the U.S. Food and Drug Administration.
The Cedars-Sinai Medical Center team, led by Sarah Ghandehari, ascertained that progesterone plays a protective role in cases of COVID-19 infection. It is able to reduce the severity of illness, the need for hospital admission and the respiratory support required.
The trial enrolled 42 patients with an average age of 55 years admitted to hospital with SARS-CoV-2 with evident involvement of the lower respiratory tracts. They were randomly assigned to either a control group treated in the conventional way (22 patients) or to a treatment group, in which 100 mg of subcutaneous progesterone was administered twice a day for five days, in addition to conventional treatment (20 patients). According to the results, patients treated with progesterone were able to reduce respiratory support by three days and hospitalisation by a total of two and half days compared with those in the control group, without any adverse events attributable to progesterone.
The results are very promising and suggests that administration of progesterone in association with ‘standard therapy’ may offer a safe and effective COVID-19 treatment approach, improving the clinical condition of seriously ill patients. The trial, made possible thanks to the collaboration of IBSA’s R&D Scientific Affairs in Washington D.C., has paved the way for further research with larger sample sizes and people with different characteristics, such as post-menopausal women, to definitively establish the degree of clinical effectiveness and safety of this treatment protocol.
“The subcutaneous formulation of progesterone produced by IBSA has a high degree of local and systemic tolerability,” states Giuseppe Roberto Mautone, Head of IBSA Group R&D Scientific Affairs, “and as such can be used in this type of trial. We’re delighted to have helped Cedars-Sinai Medical Center in Los Angeles in this pilot trial and to have given Sarah Ghandehari and her team the opportunity to better understand some of the mechanisms underlying COVID-19 infection.”
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