Dexamethasone Reduces Death in Severe COVID-19 Disease
Finally, a major breakthrough in the treatment of severe COVID disease!
Researchers announced preliminary findings from one arm of the RECOVERY Trial.
RECOVERY is a multicenter study being performed in the United Kingdom where patients hospitalized with COVID-19 disease are being randomized to one of several treatment arms.
On 06/05/20, the investigators terminated the hydroxychloroquine (HCQ) arm of the study and concluded that inpatients did not benefit from treatment with HCQ.
On 06/08/20, the investigators terminated another arm of the study in which subjects had been given dexamethasone (a steroid).
Preliminary findings from this group were published on 06/16/20. For patients who required mechanical ventilation, dexamethasone reduced mortality by 35%. For those who required oxygen, the mortality reduction was 20%. Both of these effects were statistically significant (they were not the result of chance).
Dexamethasone is a very inexpensive drug and has been used in the United States for decades. Assuming these findings are correct, this is a major development.
It is important to note that patients who did not require oxygen or mechanical ventilation did not benefit from treatment, so this study would lead us to conclude that dexamethasone is likely not helpful in outpatients.
These findings are preliminary and may be revised as additional data is analyzed. And, while encouraging, we have only seen a press release at this point. A full peer-reviewed publication will hopefully follow soon.
Additional RECOVERY study arms will examine the use of azithromycin (a commonly-used antibiotic), lopinavir/ritonavir (used to treat HIV disease) convalescent plasma (collected from donors who have recovered from COVID-19) and tocilizumab (an injected anti-inflammatory medication used in the treatment of rheumatoid arthritis). These arms of the study are ongoing.
For those interested in details and statistics:
A total of 2104 patients were randomised to receive dexamethasone 6 mg once per day (either by mouth or by intravenous injection) for 10 days and were compared with 4321 patients randomised to usual care alone.
Among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%).
Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021). There was no benefit among those patients who did not require respiratory support (1.22 [0.86 to 1.75]; p=0.14). Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.