Monday, June 22, 2020

Saving the Sickest - A Treatment Option for Severe COVID-19 Infections

A major study in the United Kingdom has found surprising results from the use of a readily available and inexpensive drug which was used to improve the survival odds of critically ill COVID-19 patients.  While the data from the study has not been published or peer reviewed, experts including Patrick Vallance, the United Kingdom government's chief scientific advisor called the result "ground-breaking" and former commissioner of the United States Food and Drug Administration, Scott Gottlieb, called the result a "very positive finding".


The Randomized Evaluation of COVid-19 thERapY or RECOVERY trial took place at Oxford University during March 2020 with over 11,500 patients, using a range of potential treatments for COVID-19 as follows:


1.) Lopinavir - Ritonavir commonly used to treat HIV


2.) Low-dose Dexamethasone - a corticosteroid hormone which decreases the body's defense response


3.) Hydroxchloroquine


4.) Azithromycin - a common antibiotic


5.) Tocilizumab - an injectable anti-inflammatory


6.) Convalescent plasma - collected from donors who have recovered from the SARS-CoV-2 virus


Among these treatments, physicians used low-dose dexamethasone, a steroid that is commonly available.  A total of 2,104 patients were randomly selected to receive 6 mg of dexamethasone by mouth or by injections once daily for ten days.  The results of the treatment with dexamethasone was compared to a cohort of 4,321 patients who received usual levels of care only.  


Here are the results:


1.) Usual Care Only - Among those who received usual care only, 28-day mortality was highest among those who required ventilation (41 percent), intermediate among those who required oxygen only (25 percent) and lowest among those who did not require any respiratory assistance (13 percent).


2.) Dexamethasone Treatment - treatment reduced deaths by 35 percent in ventilated patients, by 20 percent in patients receiving oxygen only and no benefit was noted in patients who did not require any respiratory assistance.  


Based on these results, the study concludes that one death would be prevented by the treatment of 8 ventilated patients or 25 patients who required oxygen only.  Overall, the treatment with dexamethasone reduced the 28-day mortality rate by 17 percent and showed the most significant results among patients who required ventilation.


The researchers who were conducting the study made the decision to end enrolling patients on dexamethasone on June 8, 2020 because they believed that they had sufficient data to get a clear and scientifically sound conclusion.


Here is a link to the Oxford news release should you be interested in reading the entire document.


This study is particularly interesting because it offers hope to COVID-19 patients who are severely ill with Acute Respiratory Distress Syndrome or ARDS, a condition that occurs in profoundly ill patients whose immune system is attacking their lungs.  While the study is not yet complete, we do know one thing; the potential use of a readily available and inexpensive on-the-shelf drug, dexamethasone, to save the lives of some of the most critically ill COVID-19 patients certainly will not make Big Pharma happy since the profit margins from a generic drug are far lower than it will be for one of their incompletely tested coronavirus vaccines.


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