COVID-19: Dexamethasone is effective in treating severe cases
Dexamethasone could reduce mortality from COVID-19
Accurate as a whole (with reservations)
On June 16, 2020, an article in the newspaper La Presse stated that "a new drug would reduce mortality related to COVID-19". This statement is accurate on the whole, but with reservations.
The article explained that the drug in question is dexamethasone, a low-cost corticosteroid used to treat several conditions because of its anti-inflammatory and immunosuppressive effects. It is primarily the latter property that plays a role in reducing mortality in people with COVID-19.
As explained in another COVID-19 Facts fact check, COVID-19 causes respiratory complications in some patients, due to an overreaction of the immune system. The immune system, instead of protecting the body by attacking only foreign bodies, also attacks organs, causing blood clots, multi-system organ failure, swelling of the toes, etc... It is this overreaction of the immune system, called "cytokine storm", that leads some COVID-19 patients to need respiratory assistance. Because of its immune system-reducing (immunosuppressive) property, dexamethasone helps save patients from COVID-19. It only does so in patients suffering from a severe form of COVID-19, which is the reason for our reservation.
Encouraging preliminary results
The article in La Presse was based on a press release giving the preliminary conclusions of a study by the University of Oxford, via a large clinical trial called RECOVERY, an initiative of the British government in the fight against COVID-19. The arm of the trial testing dexamethasone treated approximately 2,100 patients with a daily dose of 6mg of dexamethasone for 10 days. Patient progress was compared to a randomized sample of just over 4,321 patients who received the usual treatments. Preliminary findings indicate that dexamethasone could reduce deaths by one-third in ventilator patients and by one-fifth in patients receiving oxygen alone. However, mortality was not reduced for patients who did not require respiratory assistance.
These results made dexamethasone the first drug shown to reduce the mortality rate in patients with severe COVID-19. In a statement, the World Health Organization (WHO) hailed the discovery as a "scientific breakthrough". However, WHO said it will coordinate a meta-analysis with other studies to improve its understanding of the efficacy and safety of the treatment. It also added that its recommendations will be updated to reflect when and how dexamethasone should be used in patients with COVID-19. Preliminary results from RECOVERY were finally reviewed by a committee and published in the New England Journal of Medicine later in July.
WHO, EU and US approvals and recommendations
A meta-analysis coordinated by WHO and the University of Bristol, published on September 2 in the Journal of the American Medical Association (JAMA), explains that 7 international studies (including that of RECOVERY), show that corticosteroids reduce the risk of mortality by 21% when used in patients suffering from a severe form of COVID-19.
The meta-analysis pooled data from 1703 patients from 12 countries who randomly received either a corticosteroid such as dexamethasone, hydrocortisone or methylprednisolone (678 patients) or usual care or placebo (1025 patients). After a period of 3 to 4 weeks, it was found that the mortality rate in patients treated with corticosteroids was 21% lower than in patients receiving standard care with or without placebo. In addition, the treatment reduced the length of hospitalization for patients.
The compilation of these data led WHO to update (again on September 2) its recommendations to include "the routine use of corticosteroids in patients with severe or critical forms" of COVID-19.
As for dexamethasone, its low price and wide availability make it easily accessible, even in low-income countries. Without waiting for the publication of WHO’s recommendations, several countries such as the United Kingdom, South Africa and Japan, started to use corticosteroids such as dexamethasone in the treatment of COVID-19 in patients requiring oxygen or being ventilated.
After WHO, the European Medicines Agency (EMA) also recommended dexamethasone based on an analysis of data from the RECOVERY trial and the WHO meta-analysis. The Agency stated in a statement that it "approves the use of dexamethasone in adults and adolescents (12 years of age and older, weighing at least 40 kg) whose condition requires the administration of oxygen".
Are there any risks?
Dexamethasone generally has no side effects. WHO emphasizes that its benefit-risk ratio is favorable. However, taking the drug (corticosteroids in general) over a period of 2 weeks or more can lead to undesirable effects such as water retention, mood swings, weight gain and vision problems. Patients with COVID-19 only require a low dose, which should limit side effects.
Other treatments available (as of 25 September 2020)
At present, there are no globally authorized treatments or vaccines specifically against COVID-19. However, patients can be treated depending on their clinical condition, as recommended by national authorities and clinical judgment. This is the case with dexamethasone (for severe cases) in Canada. Other treatments such as Remdisivir (preferably in controlled clinical trials) are also allowed. In the United States, the Food and Drug Administration (FDA) also permits, for emergency use in hospitalized patients, treatment with plasma from patients who have recovered from COVID-19. Chloroquine or hydroxychloroquine have been shown to be ineffective and are not recommended.
New England Journal of Medicine
Journal of the American Medical Association (JAMA)
European Medicines Agency
Food and Drug Administration (USA)
Dexamethasone could reduce mortality from COVID-19
September 25, 2020
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