GLUCOCOVID: A controlled trial of methylprednisolone in adults hospitalized with COVID-19 pneumonia (preprint)

ABSTRACT

BackgroundWe aimed to determine whether a 6-day course of intravenous methylprednisolone (MP) improves outcome in patients with SARS CoV-2 infection at risk of developing Acute Respiratory Distress Syndrome (ARDS). MethodsMulticentric, partially randomized, preference, open-label trial, including adults with COVID-19 pneumonia, impaired gas exchange and biochemical evidence of hyper-inflammation. Patients were assigned to standard of care (SOC), or SOC plus intravenous MP [40mg/12h 3 days, then 20mg/12h 3 days]. The primary endpoint was a composite of death, admission to the intensive care unit (ICU) or requirement of non-invasive ventilation (NIV). ResultsWe analyzed 85 patients (34, randomized to MP; 22, assigned to MP by clinicians preference; 29, control group). Patients age (mean 68{+/-}12 yr) was related to outcome. The use of MP was associated with a reduced risk of the composite endpoint in the intention-to-treat, age-stratified analysis (combined risk ratio -RR-0.55 [95% CI 0.33-0.91]; p=0.024). In the per-protocol analysis, RR was 0.11 (0.01-0.83) in patients aged 72 yr or less, 0.61 (0.32-1.17) in those over 72 yr, and 0.37 (0.19-0.74, p=0.0037) in the whole group after age-adjustment by stratification. The decrease in C-reactive protein levels was more pronounced in the MP group (p=0.0003). Hyperglycemia was more frequent in the MP group. ConclusionsA short course of MP had a beneficial effect on the clinical outcome of severe COVID-19 pneumonia, decreasing the risk of the composite end point of admission to ICU, NIV or death. O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=142 SRC="FIGDIR/small/20133579v1_ufig1.gif" ALT="Figure 1"> View larger version (42K) org.highwire.dtl.DTLVardef@1adf5f9org.highwire.dtl.DTLVardef@1efecd8org.highwire.dtl.DTLVardef@a65f07org.highwire.dtl.DTLVardef@a8df92_HPS_FORMAT_FIGEXP M_FIG C_FIG