Background: Low-dose corticosteroids have been shown to reduce mortality for hypoxic COVID-19 patients requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation or extra-corporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group. Methods: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (i.e. receiving oxygen or with oxygen saturation <92% on room air) were randomly allocated (1:1) to either usual care with higher dose corticosteroids (dexamethasone 20 mg once daily for 5 days followed by 10 mg once daily for 5 days or until discharge if sooner) or usual standard of care alone (which includes dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality. On 11 May 2022, the independent Data Monitoring Committee recommended stopping recruitment of patients receiving no oxygen or simple oxygen only to this comparison due to safety concerns. We report the results for these participants only. Recruitment of patients receiving ventilatory support continues. The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 25 May 2021 and 12 May 2022, 1272 COVID-19 patients with hypoxia and receiving no oxygen (1%) or simple oxygen only (99%) were randomly allocated to receive usual care plus higher dose corticosteroids versus usual care alone (of whom 87% received low dose corticosteroids during the follow-up period). Of those randomised, 745 (59%) were in Asia, 512 (40%) in the UK and 15 (1%) in Africa. 248 (19%) had diabetes mellitus. Overall, 121 (18%) of 659 patients allocated to higher dose corticosteroids versus 75 (12%) of 613 patients allocated to usual care died within 28 days (rate ratio [RR] 1.56; 95% CI 1.18-2.06; p=0.0020). There was also an excess of pneumonia reported to be due to non-COVID infection (10% vs. 6%; absolute difference 3.7%; 95% CI 0.7-6.6) and an increase in hyperglycaemia requiring increased insulin dose (22% vs. 14%; absolute difference 7.4%; 95% CI 3.2-11.5). Interpretation: In patients hospitalised for COVID-19 with clinical hypoxia but requiring either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared to usual care, which included low dose corticosteroids. The RECOVERY trial continues to assess the effects of higher dose corticosteroids in patients hospitalised with COVID-19 who require non-invasive ventilation, invasive mechanical ventilation or extra-corporeal membrane oxygenation.
Coronavirus disease 2019 (COVID-19) is a new respiratory tract infection caused by severe acute respiratory syndrome coronavirus-2. The presence of secondary pulmonary bacterial infection (SPBI) made COVID-19 difficult to treat. Neutrophillymphocyte count ratio (NLR) is a systemic inflammatory marker used in the diagnosis and prognosis of viral or bacterial infection. At the first 3-5 days after hyperinflammation, it occurs in relation to clinical outcome. Therefore, this study aimed to evaluate the diagnostic value of NLR based on leukocyte kinetics upon admission and after 72 hours among COVID-19 patients with or without SPBI. Patients and Methods: This retrospective cross-sectional study analyzed medical records data of admitted patients with COVID-19 according to the International Classification of Disease 10th Revision (ICD-10) between January and December 2021. The list of patients was extracted and followed by a hand search to identify the inclusion or exclusion criteria and stratified into proven and nonproven SPBI based on clinical data. The study distinguished between SPBI by means of a cut-off value (COV) on the first (D1) and third day (D3), assessed using receiver operating characteristics (ROC), as well as determined the magnitude of sensitivity, specificity, and prevalence ratio. Results: A screening process was conducted on 2902 COVID-19 patients, of which 236 were included, accounting for 8.1%. Among these patients, 87 (36.9%) were found to have proven SPBI. A considerable difference in NLR value between proven and non-proven SPBI was observed on both D1 (11.1 vs 4.2) and D3 (15.3 vs 5.2), with optimal COV of NLR on D1, D3 was found to be 5.29, 9.47, respectively (p < 0.001). Conclusion: NLR on the D1 and D3 distinguished the occurrence of SPBI among COVID-19 patients. The application of NLR assisted in the early determination of bacterial infection and helped in controlling the empirical use of antibiotics.
Highlights: The combination of NLCR and PLR will improve the ability to distinguish infection rather than noninfection in the emergency setting for early antibiotic prescribing as well as the sepsis-3 strategy. The diagnostic value of PLR in adult bacterial sepsis patients has never been studied. Abstract: According to Sepsis-3, antibiotics should be administered in the first hour of diagnosis of sepsis. Still, there is difficulty in differentiating between bacterial and nonbacterial infections and a lack of a rapid diagnostic tool to distinguish them. This study evaluated the diagnostic value of NLCR and PLR in suspected bacterial sepsis. The diagnostic value of PLR in adult bacterial sepsis patients has never been studied. This study was a retrospective study from the medical record of Dr. Hasan Sadikin Hospital Bandung. All patients at age ≥ 18 years diagnosed with sepsis based on ICD-10 code and qSOFA ≥ 2 were included. We calculated sensitivity, specificity, NPV, PPV, positive LR, and AUC of NLCR and PLR. There were 177 patients included in this study. The sensitivity of NLCR was 69.5%, specificity was 34.7%, NPV was 56.9%, PPV was 47.9%, and LR+ was 1.06, while the sensitivity of PLR was 62.2%, specificity was 38.9%, NPV was 54.4%, PPV was 46.8%, and LR+ was 1.02. We obtained cut-off values for NLCR 11.06, AUC 0.500, PLR 222.41, and AUC 0.497. The low value of AUC NLCR and PLR was due to prior antibiotic use. The combination of NLCR and PLR had higher positive LR (1.16) and specificity (54.7%), and also, according to NLCR, we had the highest sensitivity (69.5%). The combination of NLCR and PLR enhances the sepsis-3 strategy because it can be used as screening tools for bacterial sepsis, and antibiotics can also be administered in the first hour of managing sepsis, particularly in the emergency ward.
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