Large Analysis Finds Steroids Increased Survival of Critical COVID-19 Patients

An analysis of seven international clinical trials published yesterday found that corticosteroids help reduce the risk of death in the most severe COVID-19 patients.

Led by researchers at the University of Bristol’s National Institute for Health Research (NIHR) and coordinated by the World Health Organization (WHO), the study analyzed seven randomized controlled trials that evaluated either dexamethasone, hydrocortisone or methylprednisolone in critical COVID-19 patients.

Results of the trials showed a 20 percent reduced risk of death when COVID-19 patients were given one of three corticosteroids, which equated to “around 68 percent of patients surviving after treatment with corticosteroids compared to around 60 percent surviving in the absence of corticosteroids,” the researchers concluded in an article in the Journal of the American Medical Association (JAMA).

Derek Angus, chief healthcare innovation officer at the University of Pittsburgh Medical Center, said the study shows that “people on ventilators or oxygen and under intensive care should definitely be given corticosteroids.”

The analyzed trials recruited 1,703 severely ill COVID-19 patients across five continents. Overall, the analysis determined that mortality results were consistent across the different studies for dexamethasone and hydrocortisone, but researchers noted there were not enough patients enrolled in trials of methylprednisolone to gauge its effect accurately.

Jonathan Sterne, deputy director of the NIHR Bristol Biomedical Research Centre, called the findings “good news” for ongoing efforts to find viable COVID-19 treatments.

“Steroids are a cheap and readily available medication, and our analysis has confirmed that they are effective in reducing deaths amongst the people most severely affected by COVID-19,” he said. “The results were consistent across the trials and show benefit regardless of age or sex.”

The analysis included critically ill patients from the University of Oxford’s RECOVERY trial. Promising results from the large trial, which were published back in June, found that dexamethasone reduced deaths by one-third in ventilated patients and by one-fifth in patients only receiving oxygen. The findings led to UK emergency authorization for the corticosteroid and a subsequent surge in demand  (DID, June 19).

Since the UK approval, the National Institutes of Health (NIH) has recommended dexamethasone and other corticosteroids for hospitalized COVID-19 patients who require supplemental oxygen or are mechanically ventilated.

And yesterday, following the JAMA study’s release, the WHO updated its treatment guidance to include a “strong recommendation” for using corticosteroids to treat severe and critical COVID-19 patients.

WHO said that corticosteroids are listed in the WHO Model List of Essential Medicines and are “readily available at a low cost.” However, both the WHO and NIH recommend against using corticosteroids for patients with mild COVID-19.

The new data are likely to lead to increased demand for corticosteroids. This was the case with dexamethasone, as the healthcare data company Vizient reported a 183 percent initial surge in demand right after the University of Oxford published the results from the RECOVERY trial.

After the initial surge, there was an additional 610 percent increase in demand for the coronavirus treatment, with fill rates dropping from 97 percent to 54 percent over a six-day period (DID, June 26).

Meanwhile, the European Medicines Agency announced that it is reviewing an application from Taw Pharma to authorize its dexamethasone for hospitalized adult patients with COVID-19. The agency is considering data from the RECOVERY trial, which its Committee for Medicinal Products for Human Use began reviewing in July (DID, July 27).

Access the JAMA article here: bit.ly/2Gl0oYJ. — James Miessler and Jordan Williams