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Development and validation of SCOPE score: A clinical score to predict COVID-19 pneumonia progression to severe respiratory failure.

ABSTRACT: Most patients infected with SARS-CoV-2 (COVID-19) experience mild, non-specific symptoms, but many develop severe symptoms associated with an excessive inflammatory response. Elevated plasma concentrations of soluble urokinase plasminogen activator receptor (suPAR) provide early warning of progression to severe respiratory failure (SRF) or death, but access to suPAR testing may be limited. The Severe COvid Prediction Estimate (SCOPE) score, derived from circulating concentrations of C-reactive protein, D- dimers, interleukin-6, and ferritin among patients not receiving non-invasive or invasive mechanical ventilation during the SAVE-MORE study, offers predictive accuracy for progression to SRF or death within 14 days comparable to that of a suPAR concentration of ≥6 ng/mL (area under receiver operator characteristic curve 0.81 for both). The SCOPE score is validated in two similar independent cohorts. A SCOPE score of 6 or more is an alternative to suPAR for predicting progression to SRF or death within 14 days of hospital admission for pneumonia, and it can be used to guide treatment decisions.

SUBMITTER: Giamarellos-Bourboulis EJ

PROVIDER: S-EPMC8872836 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceConvalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia.ObjectiveTo evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia.Design, setting, and participantsThis prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible.InterventionsPatients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations.Main outcomes and measuresThe primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization.ResultsOf the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04).Conclusions and relevanceIn patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days.Trial registrationClinicalTrials.gov Identifier: NCT04716556.

Project description:BackgroundHigh levels of serum interleukin-6 (IL-6) correlate with disease severity in COVID-19. We hypothesized that tocilizumab (a recombinant humanized anti-IL-6 receptor) could improve outcomes in selected patients with severe worsening COVID-19 pneumonia and high inflammatory parameters.MethodsThe TOCICOVID study included a prospective cohort of patients aged 16-80 years with severe (requiring > 6 L/min of oxygen therapy to obtain Sp02 > 94%) rapidly deteriorating (increase by ≥ 3 L/min of oxygen flow within the previous 12 h) COVID-19 pneumonia with ≥ 5 days of symptoms and C-reactive protein levels > 40 mg/L. They entered a compassionate use program of treatment with intravenous tocilizumab (8 mg/kg with a maximum of 800 mg per infusion; and if needed a second infusion 24 to 72 h later). A control group was retrospectively selected with the same inclusion criteria. Outcomes were assessed at D28 using inverse probability of treatment weighted (IPTW) methodology.ResultsAmong the 96 patients included (81% male, mean (SD) age: 60 (12.5) years), underlying conditions, baseline disease severity, and concomitant medications were broadly similar between the tocilizumab (n = 49) and the control (n = 47) groups. In the IPTW analysis, treatment with tocilizumab was associated with a reduced need for overall ventilatory support (49 vs. 89%, wHR: 0.39 [0.25-0.56]; p < 0.001). Albeit lacking statistical significance, there was a substantial trend towards a reduction of mechanical ventilation (31% vs. 45%; wHR: 0.58 [0.36-0.94]; p = 0.026). However, tocilizumab did not improve overall survival (wHR = 0.68 [0.31-1.748], p = 0.338). Among the 85 (89%) patients still alive at D28, patients treated with tocilizumab had a higher rate of oxygen withdrawal (82% vs. 73.5%, wHR = 1.66 [1.17-2.37], p = 0.005), with a shorter delay before being weaned of oxygen therapy (mean 11 vs. 16 days; p < 0.001). At D28, the rate of patients discharged from hospital was higher in the tocilizumab group (70% vs. 40%, wHR = 1.82 [1.22-2.75]; p = 0.003). The levels of CRP and fibrinogen post therapy (p < 0.001 for both variables) were significantly lower in the tocilizumab group (interaction test, mixed model). Rates of neutropenia (35% vs. 0%; p < 0.001) were higher in the tocilizumab group, yet rates of infections (22% vs. 38%, p = 0.089) including ventilator-acquired pneumonia (8% vs. 26%, p = 0.022) were higher in the control group.ConclusionThese data could be helpful for the design of future trials aiming to counter COVID-19-induced inflammation, especially before patients require admission to the intensive care unit.

Project description:Background and objectivesOsmotic demyelination syndrome is the most concerning complication of severe hyponatremia, occurring with an overly rapid rate of serum sodium correction. There are limited clinical tools to aid in identifying individuals at high risk of overcorrection with severe hyponatremia.Design, setting, participants, & measurementsWe identified all patients who presented to a tertiary-care hospital emergency department in Ottawa, Canada (catchment area 1.2 million) between January 1, 2003 and December 31, 2015, with serum sodium (corrected for glucose levels) <116 mmol/L. Overcorrection was determined using 14 published criteria. Latent class analysis measured the independent association of baseline factors with a consensus overcorrection status on the basis of the 14 criteria, and was summarized as a risk score, which was validated in two cohorts.ResultsA total of 623 patients presented with severe hyponatremia (mean initial value 112 mmol/L; SD 3.2). The prevalence of no, unlikely, possible, and definite overcorrection was 72%, 4%, 10%, and 14%, respectively. Overcorrection was independently associated with decreased level of consciousness (2 points), vomiting (2 points), severe hypokalemia (1 point), hypotonic urine (4 points), volume overload (-5 points), chest tumor (-5 points), patient age (-1 point per decade, over 50 years), and initial sodium level (<110 mmol/L: 4 points; 110-111 mmol/L: 2 points; 112-113 mmol/L: 1 point). These points were summed to create the Severe Hyponatremic Overcorrection Risk (SHOR) score, which was significantly associated with overcorrection status (Spearman correlation 0.45; 95% confidence interval, 0.36 to 0.49) and was discriminating (average dichotomized c-statistic 0.77; 95% confidence interval, 0.73 to 0.81). The internal (n=119) and external (n=95) validation cohorts had significantly greater use of desmopressin, which was significantly associated with the SHOR score. The SHOR score was significantly associated with overcorrection status in the internal (P<0.001) but not external (P=0.39) validation cohort.ConclusionsIn patients presenting with severe hyponatremia, overcorrection was common and predictable using baseline information. Further external validation of the SHOR is required before generalized use.

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Development and validation of SCOPE score: A clinical score to predict COVID-19 pneumonia progression to severe respiratory failure.

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