In severe hypoxemic COVID 19 patients, 6mg/ day and 12mg/day Dexamethasone equally effective: JAMA

Dexamethasone is a corticosteroid used popularly for its anti-inflammatory and immunosuppressant effects. WHO in 2020 issued an interim guideline on the use of dexamethasone and other corticosteroids for the treatment of COVID-19.

A randomized clinical trial by The Covid Steroid 2 Trial Group revealed that in COVID-19 infection compared with 6 mg of dexamethasone, 12 mg of dexamethasone did not statistically significantly reduce the number of days alive without life support at 28 days.

The findings are published in JAMA Network.

The objective of the study was to assess the effects of 12 mg/day vs 6 mg/day of dexamethasone in patients with COVID-19 and severe hypoxemia.

The study was multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India. 90-day follow-up was in August 2021, patients who needed 10L/min oxygen were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. The primary outcome was the number of days alive without life support at 28 days. Secondary outcomes, included the number the number of days alive out of the hospital at 90 days or without life supportat 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days.

The results of the study were

• A total of 1000 randomized patients, 982 were included. 971 showed primary outcome (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group).

• The median number of days alive without life support was 22.0 days in 12 mg of dexamethasone group and 20.5 days in the 6 mg of dexamethasone group.

• Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group.

• Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group.

• Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group.

The Covid Steroid 2 Trial Group concluded that "Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference."

Reference : 

The COVID STEROID 2 Trial Group. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial. JAMA. Published online October 21, 2021.

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