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1.
Critical Care Conference: 42nd International Symposium on Intensive Care and Emergency Medicine Brussels Belgium ; 27(Supplement 1), 2023.
Article in English | EMBASE | ID: covidwho-2316327

ABSTRACT

Introduction: Anakinra treatment is approved for the treatment of COVID-19 pneumonia in hospitalized adults in need of oxygen and at risk for progression into severe respiratory failure (SRF) defined as circulating concentrations of the biomarker suPAR (soluble urokinase plasminogen activator receptor) >= 6 ng/mL by the EMA and has been authorized for emergency use by FDA under an EUA [1]. This is based on the results of the randomized SAVE-MORE trial where suPAR >= 6 ng/ mL was used to select patients at risk for SRF [2]. The suPAR test is not commercially available in the USA and an alternative method of patient selection was needed. Method(s): In collaboration with the US FDA, an alternative method to select patients most likely to have suPAR >= 6 ng/mL based on commonly measured patient characteristics was developed. Patients with at least 3 of the following criteria are considered likely to have suPAR >= 6 ng/ ml: age >= 75 years, severe pneumonia by WHO criteria, current/previous smoking status, Sequential Organ Failure Assessment score >= 3, neutrophil-to-lymphocyte ratio >= 7, hemoglobin <= 10.5 g/dl, history of ischemic stroke, blood urea >= 50 mg/dl and/or history of renal disease. Result(s): The positive predictive value of this new score was 95.4% in SAVE-MORE population. However, a lower sensitivity meant a small proportion of patients with suPAR >= 6 ng/ml will not be identified by the new score. The adjusted hazard ratio for survival at 60 days for patients meeting this score and who receive anakinra is 0.45 (Fig. 1). Conclusion(s): The developed score predicts accurately patients with suPAR levels >= 6 ng/mL and may be used as an alternative to guide anakinra treatment in patients with COVID-19 pneumonia. Based on these subgroup results, patients in SAVE-MORE who met the new score appeared to show beneficial efficacy results with treatment of anakinra consistent with the overall studied population.

3.
European Respiratory Journal ; 60(Supplement 66):1955, 2022.
Article in English | EMBASE | ID: covidwho-2301162

ABSTRACT

Background: Growing evidence focuses on the role of hypoalbuminemia in the COVID-19 course and the role of vascular inflammation in the progression to Capillary Leak Syndrome (CLS). CLS may be mediated by a derangement of endothelial barrier following vascular endothelial dysfunction. We investigated the role of cardiometabolic risk factors in the association of hypoalbuminemia with endothelial dysfunction of hospitalized COVID-19 patients. Method(s): In this cross-sectional study, patients hospitalized for COVID- 19 at the medical ward or Intensive Care Unit (ICU) were enrolled. Medical history and laboratory examinations were collected while the endothelial function was assessed by brachial artery flow-mediated dilation (FMD) between the first 24-72 hours of their admission to the hospital. According to the body mass index, history of hypertension, dyslipidemia, and diabetes mellitus, COVID-19 patients were categorized in those with Cardiometabolic Risk Factors (CRFact) or without CRFact (no-CRFact). From the study population, we excluded subjects with established cardiovascular disease. Result(s): Sixty-six patients with COVID-19 (37% admitted in ICU) were recruited. From the study population, 41 were in the group of CRFact and 25 in the no-CRFact. Patients with CFRact were older (65+/-9 years vs. 53+/-14 years, p<0.001), had more impaired FMD (1.16+/-2.13% vs. 2.60+/-2.44%, p=0.01), and lower serum albumin levels (3.10+/-0.68 g/dL vs. 3.52+/-0.26 g/dL, p=0.006) compared to the no-CRFact group. Between CRFact and no-CRFact, there was no difference in CRP and IL-6 levels. Interestingly, serum albumin in patients with CRFact was significantly lower than the lower reference limit (LRL) (=3.5 g/dl) of albumin (p=0.001), while no such finding was noted in subjects with no CRFact (p=0.64). Furthermore, regression analysis revealed that, even after adjustment for age, the presence of CRFact was associated with decreased serum albumin levels by 0.31mg/dl (95% CI 0.08 to 0.63, p=0.04). In the CRFact population, there was a correlation of albumin with FMD (R=0.29, p=0.05) and an inverse correlation with CRP (rho=-0.48, p=0.02) and IL-6 (rho=-0.66, p<0.001), while in the no-CRFact group no such correlation were observed (p=NS for all). Conclusion(s): COVID-19 patients with cardiometabolic risk factors present with low serum albumin levels early at the course of the disease, which may be driven by endothelial dysfunction and vascular inflammation. This data gives insights into the potential association of a dysfunctional endothelial layer and the progression to capillary leak syndrome. (Figure Presented).

4.
Open Forum Infectious Diseases ; 9(Supplement 2):S494, 2022.
Article in English | EMBASE | ID: covidwho-2189805

ABSTRACT

Background. EXO-CD24 is a novel inhaled drug of exosomes displaying CD24, a protein with anti-inflammatory properties. We evaluated the safety and potential efficacy of EXO-CD24, in a phase II, randomized, single-blinded clinical trial of EXO-CD24 in hospitalized patients with moderate or severe COVID-19, following the preliminary safety and efficacy results of a phase 1 study (ClinicalTrials.gov: NCT04747574). Methods. Two tertiary care hospitals in Athens, Greece participated. Patients received either 109 or 1010 exosome particles per dose, once per day for 5 days and were followed for 28 days. Safety and efficacy measures (including respiratory rate < 23 b/ min and pulse oximetry SpO2>= 94% on room air, oxygen need and levels of inflammatory biomarkers i.e. CRP, LDH, ferritin, fibrinogen and d-dimers) were compared between groups at days 3, 5 and 7. A separate analysis was conducted comparing the clinical course of treated patients with that of a control cohort (n=70 patients) matched by propensity scoring out of a similar period hospitalized cohort (n=202) that did not participate in the study. Results. Between June 9th and August 3rd 2021, 91 patients underwent randomization: 45 in group A and 46 in group B (109 vs. 1010 exosome particles per dose). Mean age was 49.4 (+/- 13.2) years and 74.4% were male. Mean time from symptom onset to randomization was 8 days. Improvement in respiratory rate and pulse oximetry was noted in 72 out of 86 (83.7%) and 55 out of 86 (64%) analyzed patients. Day 7 inflammatory indices levels dropped at least 50% from baseline admission values in 72 out of 86 (82.8%) analyzed patients (p< 0.001). No treatment-related adverse events were reported. Comparison with the propensity score matched group showed statistically significant differences in the same parameters (p<= 0.01 for all comparisons). Conclusion. Our results suggest safety and potential efficacy of EXO-CD24 on clinical and laboratory parameters of moderate or severe COVID-19, that deserve further investigation in a phase 3 study. (Funded by Athens Medical Society. ClinicalTrials.gov: NCT04902183, EU Clinical Trials Register EudraCT Number 2021-002184-22).

7.
Journal of Crohn's and Colitis ; 16:i437, 2022.
Article in English | EMBASE | ID: covidwho-1722337

ABSTRACT

Background: Accumulating evidence suggests a beneficial effect of tumor necrosis factor-alpha (TNF-α) inhibitors on the outcomes of COVID-19 disease, which, however, is not validated by all studies. We aimed to perform a systematic review and meta-analysis of existing reports to investigate the impact of anti-TNF treatments on the clinical outcomes of COVID-19 patients. Methods: A systematic search at PubMed and SCOPUS databases using specific keywords was performed. All reports of COVID-19 outcomes for patients receiving anti-TNF therapy by September-2021 were included. Pooled effect measures were calculated using a randomeffects model. The Newcastle Ottawa Scale for observational studies was used to assess bias. Studies that were not eligible for meta-analysis were described qualitatively. Results: In total, 84 studies were included in the systematic review, and 31 were included in the meta-analysis. Patients receiving anti-TNF treatment, compared to non-anti-TNF, among confirmed COVID-19 cases had a lower probability of hospitalisation (25 studies, pooled OR=0.34, 95%CI:0.30-0.38, I2=0) and severe disease defined as intensive care unit admission or death (eight studies, pooled OR=0.38, 95%CI: 0.27-0.55, I2=0). After adjustment for validated predictors of adverse disease outcomes, patients receiving anti-TNF treatment, compared to non-anti-TNF, among confirmed COVID-19 cases preserved a lower probability of hospitalisation (eight studies, pooled OR=0.53, 95%CI:0.42-0.67, I2=0) and severe disease (two studies, pooled OR=0.63, 95%CI: 0.41-0.96, I2=0). No difference was found for the risk for hospitalisation due to COVID-19 in populations without COVID-19 for patients receiving anti-TNF treatment compared to non-anti-TNF (three studies, 5,994,958 participants, pooled Risk Ratio=0.97, 95%CI: 0.68-1.39, I2=20) adjusted for age, sex and comorbidities. Conclusion: TNF-α inhibitors are associated lower probability of hospitalisation and severe COVID-19 when compared to any other treatment for an underlying inflammatory disease.

8.
Microorganisms ; 9(4):11, 2021.
Article in English | MEDLINE | ID: covidwho-1209741

ABSTRACT

COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention (n = 59) to a control group (n = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004-0.36), p: 0.005], significantly better overall survival by Kaplan-Meir analysis (p < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64-348.9), p: 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209).

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