Multiple Studies Find Steroids Fight Severe COVID
By EJ Mundell
WEDNESDAY, September 2, 2020 (HealthDay News) – Series of ‘landmark’ clinical trials offer new hope for patients with severe COVID-19: Common, cheap drugs known as corticosteroids appear to reduce rate one-third mortality.
The release of new data on treatment with corticosteroids such as hydrocortisone or dexamethasone “represents an important milestone in the treatment of patients with COVID-19,” Dr. Hallie Prescott of the University of Michigan told Ann Arbor and Dr. Todd Rice, of Vanderbilt University in Nashville, Tenn.
They wrote an editorial accompanying four studies on corticosteroids and COVID-19, all published online September 2 in the Journal of the American Medical Association (JAMA).
One of the studies was a “meta-analysis” – a review of data looking at the combined results of seven different clinical trials. These trials have involved more than 1,700 critically ill patients with COVID-19 treated at medical centers in 12 countries.
Data showed that the use of corticosteroids in the management of these patients reduced the death rate (after one month of treatment) by about a third, according to researchers led by Jonathan Sterne of the University of Bristol UK. This finding was true for patients requiring mechanical ventilation as well as those who required supplemental oxygen but not a ventilator, the research team added.
Overall, “these trial results from various clinical and geographic settings suggest that in the absence of convincing contraindications, a corticosteroid regimen should be part of standard care for critically ill patients with COVID- 19 ”, concluded the Sterne group.
Calm the storm
How could corticosteroids – which have been around for decades – help save lives threatened by COVID-19? As Prescott and Rice explained, these drugs work to counter the out-of-control inflammatory response – the so-called “cytokine storm” – that can drive COVID-19 to advanced stages and overwhelm patients’ defenses.
In addition, many patients treated for COVID-19 in the intensive care unit (ICU) need ventilators to breathe as they develop a condition known as acute respiratory distress syndrome (ARDS). ARDS is often seen in advanced cases of pneumonia and other illnesses, and can easily prove fatal.
But Prescott and Rice noted that as early as 1967, experts noted that “corticosteroids appeared to have value in treating patients” with severe pneumonia and ARDS.
In June, the first strong evidence that the drugs could fight COVID-19 also emerged, with the publication of the results of a UK trial involving more than 6,400 patients. This trial found that the use of dexamethasone reduced the death rate by about a third for patients on ventilators and by about a fifth for those requiring supplemental oxygen.
In the latest issue of JAMA, researchers working on three new clinical trials have found preliminary results indicating that corticosteroids help against COVID-19.
A trial in Brazil, involving 299 patients treated in intensive care units, found that adding dexamethasone to treatment “resulted in a statistically significant increase in the number of days without a ventilator” over 28 days of treatment. Two other trials – one in France and the other including American patients – also suggested a real improvement in the use of corticosteroids.
The “ clearest answer ”
The US trial involved 403 COVID-19 patients treated in an intensive care unit between March and June. It found a 93% chance that adding intravenous hydrocortisone to the treatment of patients would lead to better results.
“It gives doctors like me, who treat the sickest of the sick, hope. We are starting to understand the deadly side of this disease,” study co-author Dr Bryan McVerry said in a press release from the University of Pittsburgh. He is associate professor of pulmonology, allergy and critical care medicine at Pitt.
Lead author of the study, Dr Derek Angus, who heads Pitt’s critical care medicine department, added that “it is relatively rare in medicine to find drugs with evidence of their efficacy to save lives are so consistent. Respects, the one clearest answer we have had so far on how to deal with terribly ill COVID-19 patients. People on ventilators or oxygen and in intensive care should definitely receive corticosteroids. “
However, the publication of clear evidence of benefit from the UK trial in June meant that discontinuing corticosteroid therapy in patients in the “control” arms of the Brazilian, French and US trials was no longer ethical, so that each of these trials was terminated prematurely.
Meta-analysis of data from seven different studies was completed, however, and shows clear benefit from corticosteroid therapy.
According to the meta-analysis, the steroid dexamethasone has been used in three trials involving a total of nearly 1,300 patients, and appears to reduce the risk of death by 36% compared to standard care.
Hydrocortisone was used in three trials involving a smaller number of patients (374) and reduced the risk of death by 31%, the Sterne group reported.
Corticosteroids can have serious side effects, but the meta-analysis found little difference in “serious adverse events” between patients who received the drugs and those who did not.
Yet some questions remain. According to editorialists Prescott and Rice, these questions include: “Does inflammation rebound after stopping corticosteroids? … Should less seriously ill or out-of-hospital patients be treated with corticosteroids? … Remdesivir or should other potentially active therapies be given with corticosteroids? “
Overall, however, the results of the new trials published online September 2 at JAMA are encouraging, said Prescott and Rice.
“The COVID-19 pandemic has brought fear and a sea of change to the world,” they said. “These studies provide evidence and some hope that an effective, inexpensive and safe treatment has been identified.”
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