Abstract
The optimal treatment for patients with severe coronavirus-19 disease (COVID-19) and hyper-inflammation remains debated. A cohort study was designed to evaluate whether a therapeutic algorithm using steroids with or without interleukin-1 antagonist (anakinra) could prevent death/invasive ventilation. Patients with a ≥5-day evolution since symptoms onset, with hyper-inflammation (CRP≥50mg/L), requiring 3-5 L/min oxygen, received methylprednisolone alone. Patients needing ≥6 L/min received methylprednisolone + subcutaneous anakinra daily either frontline or in case clinical deterioration upon corticosteroids alone. Death rate and death or intensive care unit (ICU) invasive ventilation rate at Day 15, with Odds Ratio (OR) and 95% CIs, were determined according to logistic regression and propensity scores. A Bayesian analysis estimated the treatment effects. Of 108 consecutive patients, 70 patients received glucocorticoids alone. The control group comprised 63 patients receiving standard of care. In the corticosteroid±stanakinra group (n = 108), death rate was 20.4%, versus 30.2% in the controls, indicating a 30% relative decrease in death risk and a number of 10 patients to treat to avoid a death (p = 0.15). Using propensity scores a per-protocol analysis showed an OR for COVID-19-related death of 0.9 (95%CI [0.80-1.01], p = 0.067). On Bayesian analysis, the posterior probability of any mortality benefit with corticosteroids+/-anakinra was 87.5%, with a 7.8% probability of treatment-related harm. Pre-existing diabetes exacerbation occurred in 29 of 108 patients (26.9%). In COVID-19 non-ICU inpatients at the cytokine release phase, corticosteroids with or without anakinra were associated with a 30% decrease of death risk on Day 15.
Highlights
In COVID-19 non-intensive care unit (ICU) inpatients at the cytokine release phase, corticosteroids with or without anakinra were associated with a 30% decrease of death risk on Day 15
The coronavirus disease (COVID-19) pandemic caused by the SARS-CoV-2 virus spread worldwide within 2 months [1,2]
Corticosteroids interfere with a wide array of inflammatory pathways, they were initially actively discouraged by WHO for COVID19, based on small-sized studies on SARS-CoV-1 and MERS coronavirus infections [13]
Summary
The coronavirus disease (COVID-19) pandemic caused by the SARS-CoV-2 virus spread worldwide within 2 months [1,2]. Severe COVID-19 patients exhibited a so called “cytokine storm”, typically 5–10 days after symptom onset [6], with fever, increased oxygen requirement, and elevated inflammatory markers [7]. Corticosteroids interfere with a wide array of inflammatory pathways, they were initially actively discouraged by WHO for COVID19, based on small-sized studies on SARS-CoV-1 and MERS coronavirus infections [13]. In such diseases, either safety concerns or no clinical efficacy were reported [14,15], with possibly increase in viral load and prolonged viral shedding [16]. The optimal treatment for patients with severe coronavirus-19 disease (COVID-19) and hyper-inflammation remains debated
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