Abstract
Corticosteroids use in coronavirus disease 2019 (COVID-19) is controversial, especially in mild to severe patients who do not require invasive/noninvasive ventilation. Moreover, many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19. In this context, this multicenter, retrospective, propensity score–matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease. This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January–April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores. The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15. Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group). The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group (OR, 0.611; 95% confidence interval [CI], 0.388–0.962; p = 0.034). The time to improvement in radiological findings was significantly shorter in the corticosteroid versus non-corticosteroid group (hazard ratio [HR], 1.758; 95% CI, 1.323–2.337; p < 0.001), regardless of baseline clinical status. The duration of invasive mechanical ventilation was shorter in corticosteroid versus non-corticosteroid group (HR, 1.466; 95% CI, 0.841–2.554; p = 0.177). Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse versus standard dose group (HR, 2.831; 95% CI, 1.347–5.950; p = 0.006). In conclusion, corticosteroids for hospitalized patients with COVID-19 did not improve clinical status on Day 15, but reduced the time to improvement in radiological findings for all patients regardless of disease severity and also reduced the duration of invasive mechanical ventilation in patients who required intubation.Trial registration: This study was registered in the University hospital Medical Information Network Clinical Trials Registry on April 21, 2020 (ID: UMIN000040211).
Highlights
Abbreviations acute respiratory distress syndrome (ARDS) Acute respiratory distress syndrome confidence interval (CI) Confidence interval COVID-19 Coronavirus disease 2019 CRP C-reactive protein computed tomography (CT) Computed tomography extracorporeal membrane oxygen therapy (ECMO) Extracorporeal membrane oxygen therapy WHO World Health Organization FiO2 Fraction of inspired oxygen high-flow nasal cannula (HFNC) High-flow nasal cannula hazard ratio (HR) Hazard ratio IL Interleukin MERS-CoV Middle East respiratory syndrome coronavirus noninvasive positive pressure ventilation (NIPPV) Noninvasive positive pressure ventilation odds ratio (OR) Odds ratio polymerase chain reaction (PCR) Polymerase chain reaction SARS-CoV Severe acute respiratory syndrome coronavirus standard deviation (SD) Standard deviation SpO2 Oxygen saturation
Of 1141 consecutive hospitalized patients with COVID-19 registered by June 30, 2020, 49 patients were excluded from this study based on these criteria: (1) diagnosis after May 2020 (25 patients); (2) duplicate registrations from 2 facilities (11 patients); (3) no clinical status information for Day 1 due to transfer from another hospital (9 patients); (4) no need to be hospitalized (2 patients), (5) PCR testing only performed on spinal fluid (1 patient), and (6) negative results on PCR, but clinical diagnosis (1 patient)
The remaining 72 patients (30.6%) who started corticosteroid > 4 days after admission had a greater decline in SpO2/FiO2 from admission to just before corticosteroid initiation and a significantly worse score on the 7-point ordinal scale on Day 15 compared with the 163 early-treatment patients (Supplemental Table 3 and 4)
Summary
Abbreviations ARDS Acute respiratory distress syndrome CI Confidence interval COVID-19 Coronavirus disease 2019 CRP C-reactive protein CT Computed tomography ECMO Extracorporeal membrane oxygen therapy WHO World Health Organization FiO2 Fraction of inspired oxygen HFNC High-flow nasal cannula HR Hazard ratio IL Interleukin MERS-CoV Middle East respiratory syndrome coronavirus NIPPV Noninvasive positive pressure ventilation OR Odds ratio PCR Polymerase chain reaction SARS-CoV Severe acute respiratory syndrome coronavirus SD Standard deviation SpO2 Oxygen saturation. Recent results of several randomized trials of corticosteroids against COVID-19 have been r eported[15,16,17,18], in which the therapy reduced the 28-day mortality and increased the number of ventilator-free days in critically ill patients with COVID-1915,16 In light of these results, the latest World Health Organization (WHO) guidance recommends corticosteroids for severe and critical patients[19]. Many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19, such as initial dose, administration period, and timing of initiation In this context, this multicenter, retrospective, propensity score–matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease. Various subgroup analyses were performed to examine in detail the appropriate use of corticosteroids for COVID-19
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