1,721,043 research outputs found
Poor survival with extracorporeal membrane oxygenation in acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19): Pooled analysis of early reports
No full textThe results of this analysis using currently available literature would suggest that ECMO does not seemingly produce neither harm or benefit in COVID-19 patients progressing to ARDS
Active smoking is not associated with severity of coronavirus disease 2019 (COVID-19)
No full textActive smoking is not associated with severity of coronavirus disease 2019 (COVID-19
COVID-19 diagnostics and early phase clinical trials: challenges and risk mitigation in the Omicron variants era
No full textThe evolution of the coronavirus disease 2019 (COVID-19) pandemic and widespread community of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants continues to present new challenges for early phase clinical trials and COVID-19 diagnostic strategies. Many regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to provide updated guidance on the operations of clinical trials during the pandemic. However, guidance is limited with respect to medical and scientific specific issues, such as COVID-19 diagnostics. Here we discuss, the challenges for early phase studies associated with COVID-19 diagnostics in the Omicron era and potential risk mitigation strategies in the face of continued widespread community transmission. We note how careful consideration and planning can help mitigating the risk of COVID-19 impacting the medical and scientific validity and patient safety in clinical trials. Clinical study design should consider mitigation strategies at the patient, investigator, and clinical research organization (CRO)/Sponsor level following evaluation of the overall for their specific study/investigational product and patient overall wellbeing. Specific language regarding COVID-19-related policies and procedures should be included in the study protocol. Special considerations should be taken for novel immunotherapeutics which may require interruption in the event of a subject developing COVID-19 or for investigative products that may have hazardous interactions with commonly prescribed anti-COVID-19 therapies. Moving forward, its essential for trials to remain adaptable to evolving nature of the pandemic
Pooled analysis of mid-regional pro-adrenomedullin values in COVID-19 patients with critical illness
No full textWe performed a critical literature review and meta-analysis to explore as to whether MR-proADM assessment may help predicting unfavorable disease progression in COVID-9 patients. The electronic search carried out in accordance the above-mentioned criteria identified 34 documents after elimination of duplicates. Among these, 28 were excluded as they were review articles (n = 13), editorial material (n = 1) or correspondence without original data (n = 2), did not specifically deal with COVID-19 (n = 6), did not provide MR-proADM values (n = 2), lack of complete information on MR-proADM values (n = 1), or MR-proADM values were not stratified according to COVID-19 severity (n = 3). No significant disagreement emerged between the two reviewers. Six studies were thus finally included in pooled analysis, totaling 487 COVID-19 patients, 159 (32.6%) with critical illness. All included studies were cross sectional investigations, three conducted in Italy, while the others were located in Germany, Russia and Switzerland. The clinical endpoints used for characterizing critical illness of COVID-19 were cumulative mortality in two studies, as opposed to intensive care unit (ICU) admission or death, need for renal replacement therapy (RRT), death or intubation, and acute respiratory distress syndrome (ARDS) in the remaining investigations. A positive difference of MR-proADM values was found between patients with or without critical COVID-19 in each individual study. The WMD of MR-proADM values in COVID-19 patients with critical illness versus those without was 0.67 (95% CI 0.42–0.93) nmol/L in the quality effects model (with high heterogeneity, I2 = 81%), further increasing to 0.80 (95% CI 0.58–1.02) nmol/L in the random effects model. Overall, MR-proADM values were found to be increased by 74% (95% CI 46–103%) in COVID-19 patients with critical illness compared to those without
Chronic obstructive pulmonary disease is associated with severe coronavirus disease 2019 (COVID-19)
No full textChronic Obstructive Pulmonary Disease Is Associated With Severe Coronavirus Disease 2019 (COVID-19
Chronic kidney disease is associated with severe coronavirus disease 2019 (COVID-19) infection
No full textChronic kidney disease is associated with severe coronavirus disease 2019 (COVID-19) infection
Do sex-specific immunobiological factors and differences in angiotensin converting enzyme 2 (ACE2) expression explain increased severity and mortality of COVID-19 in males?
No full textCoronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2), shares similarities with the former SARS outbreak, which was caused by SARS-CoV-1. SARS was characterized by severe lung injury due to virus-induced cytopathic effects and dysregulated hyperinflammatory state. COVID-19 has a higher mortality rate in men both inside and outside China. In this opinion paper, we describe how sex-specific immunobiological factors and differences in angiotensin converting enzyme 2 (ACE2) expression may explain the increased severity and mortality of COVID-19 in males. We highlight that immunomodulatory treatment must be tailored to the underlying immunobiology at different stages of disease. Moreover, by investigating sex-based immunobiological differences, we may enhance our understanding of COVID-19 pathophysiology and facilitate improved immunomodulatory strategies
Myalgia may not be associated with severity of coronavirus disease 2019 (COVID-19)
No full textMyalgia may not be associated with severity of coronavirus disease 2019 (COVID-19)
Is there evidence of intra-uterine vertical transmission potential of COVID-19 infection in samples tested by quantitative RT-PCR?
No full textIs there evidence of intra-uterine vertical transmission potential of COVID-19 infection in samples tested by quantitative RT-PCR
Pooled analysis of efficacy of the fourth mRNA-based COVID-19 vaccine dose in eliciting anti-SARS-CoV-2 serum antibody response in the general immunocompetent population
No full textSince the opportunity of widespread administration of the fourth mRNA-based coronavirus disease 2019 (COVID-19) vaccine dose remains controversial, this article provides a pooled analysis of the efficacy of the second COVID-19 mRNA-based homologous vaccine booster in eliciting anti-SARS-CoV-2 serum antibody response in general immunocompetent populations. Methods: We conducted a digital search in Medline using the keywords "fourth dose" or "second booster" and "antibodies" and "COVID-19" or "SARS-CoV-2" and "BNT162b2" or "mRNA-1273", to identify all clinical studies which evaluated the anti-SARS-CoV-2 serum antibody response after the fourth mRNA-based COVID-19 homologous vaccine dose administration in general immunocompetent populations compared to the response seen before its administration and after the first booster. Results: Four studies totaling 571 recipients of the second mRNA-based COVID-19 vaccine booster were finally included in our analysis. The weighted mean difference (WMD) ratio of anti-SARS-CoV-2 serum antibodies levels measured after and before administration of the fourth vaccine dose was 9.7 (95% CI, 6.5-12.9) in those receiving BNT162b2 and 12.0 (95% CI, 5.8-18.2) in those receiving mRNA-1273, respectively. The WMD ratio of anti-SARS-CoV-2 serum antibodies levels measured at the peak of the fourth and third vaccine doses was 1.4 (95% CI, 1.2-1.7) in those receiving BNT162b2 and 1.9 (95% CI, 1.5-2.4) in those receiving mRNA-1273, respectively. Conclusion: Our data confirm the efficacy of the fourth mRNA-based COVID-19 vaccine dose in restoring a satisfactory level of anti-SARS-CoV-2 serum antibodies, though such effectiveness seems only marginally superior to that of the first booster
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