scholarly journals Use of convalescent plasma in hospitalized patients with COVID-19: case series

Blood ◽  
2020 ◽  
Vol 136 (6) ◽  
pp. 759-762 ◽  
Author(s):  
Livia Hegerova ◽  
Ted A. Gooley ◽  
Kelly A. Sweerus ◽  
Cynthia Maree ◽  
Neil Bailey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Benefit ◽  
Case Series ◽  
Hospitalized Patients ◽  
Controlled Clinical Trials ◽  
Early Administration ◽  
The Impact

Two case series examining the impact of convalescent plasma on patients with COVID-19 suggest some clinical benefit from early administration and modest impact on parameters of inflammation. Further assessment of the impact of this intervention awaits controlled clinical trials.

scholarly journals Improved clinical symptoms and mortality among patients with severe or critical COVID-19 after convalescent plasma transfusion

Blood ◽  
2020 ◽  
Vol 136 (6) ◽  
pp. 755-759 ◽  
Author(s):  
Xinyi Xia ◽  
Kening Li ◽  
Lingxiang Wu ◽  
Zhihua Wang ◽  
Mengyan Zhu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Benefit ◽  
Clinical Symptoms ◽  
Case Series ◽  
Plasma Transfusion ◽  
Controlled Clinical Trials ◽  
Early Administration ◽  
The Impact

Two case series examining the impact of convalescent plasma on patients with COVID-19 suggest some clinical benefit from early administration and modest impact on parameters of inflammation. Further assessment of the impact of this intervention awaits controlled clinical trials.

scholarly journals Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis

2021 ◽  
Vol 15 ◽  
pp. 175346662110280
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González-Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
David Gómez Martínez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Risk Of Bias ◽  
Hospitalized Patients ◽  
Low Risk ◽  
Controlled Clinical Trials

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.

scholarly journals A pilot trial of human amniotic fluid for the treatment of COVID-19

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Craig H. Selzman ◽  
Joseph E. Tonna ◽  
Jan Pierce ◽  
Camila Vargas ◽  
Chloe Skidmore ◽  
...  
Keyword(s):  
Amniotic Fluid ◽  
Pilot Trial ◽  
Prospective Trial ◽  
Ventilatory Support ◽  
Case Series ◽  
Hospitalized Patients ◽  
Human Amniotic Fluid ◽  
Reactive Protein ◽  
Randomized Prospective Trial ◽  
The Impact

Abstract Objective Vertical transmission from SARS CoV-2-infected women is uncommon and coronavirus has not been detected in amniotic fluid. Human amniotic products have a broad immune-mediating profile. Observing that many COVID-19 patients have a profound inflammatory response to the virus, we sought to determine the influence of human amniotic fluid (hAF) on hospitalized patients with COVID-19. Results A 10-patient case series was IRB-approved to study the impact of hAF on hospitalized patients with documented COVID-19. Nine of the 10 patients survived to discharge, with one patient succumbing to the disease when enrolled on maximal ventilatory support and severe hypoxia. The study design was altered by the IRB such that the last 6 patients received higher dose of intravenous hAF. In this latter group, patients that had observed reductions in C-reactive protein were associated with improved clinical outcomes. No hAF-related adverse events were noted. Acknowledging some of the inherent limitations of this case series, these results inform and catalyze a larger scaled randomized prospective trial to further investigate hAF as a therapy for COVID-19. Trial Registration ClinicalTrials.gov: NCT04319731; March 23, 2020

scholarly journals Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
Silvia Mercedes Coca
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Hospitalized Patients ◽  
Controlled Clinical Trials ◽  
Quantitative Synthesis ◽  
Overall Mortality

AbstractGiven the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients with diagnosis of COVID-19.We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients with a diagnosis of SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement.A total of 50 studies were retrieved from the databases. Four articles were finally included in the data extraction, qualitative and quantitative synthesis of results. The meta-analysis suggests that there is no benefit of convalescent plasma compared to standard care or placebo in the reduction of the overall mortality and in the ventilation requirement; but there could be a benefit for the clinical improvement in patients treated with plasma.We can conclude that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed.

Impact of immune-related adverse events (irAE) on overall survival (OS) in patients treated with immunotherapy for non-small cell lung cancer (NSCLC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9080-9080 ◽  
Author(s):  
Dwight Hall Owen ◽  
Lai Wei ◽  
Miguel Angel Villalona-Calero ◽  
Erin Marie Bertino ◽  
Kai He ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Benefit ◽  
Single Agent ◽  
Standard Of Care ◽  
State University ◽  
Flu Vaccination ◽  
Thoracic Radiation ◽  
The Ohio State University ◽  
The Impact

9080 Background: Immunotherapy (IO) has brought dramatic clinical benefit to patients with NSCLC. Most patients tolerate IO, but serious irAE have been reported. In melanoma, a correlation between development of irAE and clinical benefit has been suggested. For NSCLC, the risk of irAE including pneumonitis has been described in clinical trials but not for the wider population. Risk factors for irAE and the impact of irAE on OS are unknown. Methods: A retrospective review of patients with NSCLC treated with single-agent IO between September 2014 and June 2016 was carried out at The Ohio State University. Patients had confirmed pathologic disease and received IO either on clinical trial or as standard of care. IrAE were assessed based on the treating physician diagnosis. OS was calculated from the date of initiation of IO to death from any cause or date or last follow-up. Results: A total of 90 patients met criteria. Median age was 67. Histology was nonsquamous in 58 (64%) and squamous in 32 (35%). Most patients received nivolumab (n = 87). Median months of IO was 2.6 (95% CI 1.9 – 4.2). IrAE occurred in 24 patients (26.67%). The most common irAE were pneumonitis (n = 8), thyroid dysfunction (n = 6), and rash/pruritus (n = 5). Other irAE included colitis in 2 patients and new onset diabetes and autoimmune hepatitis in 1 patient each. Development of pneumonitis did not have a statistically significant impact on overall survival (median OS 5.8 vs 8.1 months, p = 0.11). Prior thoracic radiation (TR) was not associated with pneumonitis (11.54% vs 8.33%, p = 0.69), but was associated with shorter survival (median OS 3.9 vs 8.7 months, p = 0.018). Development of irAE was not associated with histology (p = 1.00), KRAS mutation (p = 0.10), TP53 mutation (p = 0.09), or recent flu vaccination (p = 1.00). Patients with irAE had longer median OS (13.2 vs 5.8 months, p = 0.018). Conclusions: The incidence of irAE and pneumonitis match that seen in published clinical trials. The development of irAE was associated with better prognosis, whereas patients with prior TR had worse outcomes. Further prospective research is warranted to investigate the correlation of irAE with clinical benefit from IO in patients with NSCLC.

Impact of value frameworks on the magnitude of clinical benefit: Evaluating a decade of randomized trials for systemic therapy in solid malignancies.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19410-e19410
Author(s):  
Ellen Cusano ◽  
Chelsea Wong ◽  
Marcus Vaska ◽  
Nancy Alice Nixon ◽  
Safiya Karim ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Primary Endpoint ◽  
Clinical Benefit ◽  
Rapid Development ◽  
Palliative Therapy ◽  
Drug Mechanism ◽  
Solid Malignancies ◽  
Significant Difference ◽  
Multivariable Analyses ◽  
The Impact

e19410 Background: In the era of rapid development of new, expensive cancer therapies, value frameworks were developed to quantify clinical benefit. We assessed the evolution of the magnitude of clinical benefit since the 2015 introduction of the ASCO and ESMO value frameworks. Methods: Randomized phase II and III clinical trials assessing systemic therapies for solid malignancies from January 2010 to July 2019 were evaluated. Study characteristics were recorded, and magnitude of clinical benefit (Δ) was calculated for the endpoints overall survival (OS), progression-free survival (PFS), response rate (RR), and quality of life (QoL). Multivariable analyses compared ΔOS, ΔPFS, and ΔRR in 2010-2014 [pre-value frameworks (PRE)] to 2015-2019 [post-value frameworks (POST)]. Results: In the 290 studies analyzed [60 (21%) PRE and 230 (79%) POST], the most common primary endpoint was PFS (46%), followed by OS (20%), RR (16%), and QoL (8%), with a non-significant increase in OS and decrease in RR as a primary endpoint in the POST era (Table). Studies evaluating immunotherapy and palliative therapy significantly increased POST [0 (0%) v 39 (17%), Fisher’s exact p<0.01 and 25 (42%) v 142 (62%), Chi squared p=0.01, respectively]. Studies reporting improvement in QoL doubled POST [3 (5%) v 22 (10%) Fisher’s exact p=0.56], however not statistically significant. Median ΔOS was significantly greater POST (N= 140 evaluable studies, 1.3 v -0.2 months, Wilcoxon p=0.005) but there was no significant difference in median ΔPFS or ΔRR. Multivariable analyses revealed significant improvement in ΔOS POST (OR 3.08, 95% CI 0.54-5.62, p=0.02) while adjusting for drug mechanism of action, line of therapy, disease setting, and primary endpoint. Conclusions: After the development of value frameworks, median OS improved minimally. The impact of value frameworks has yet to be fully realized in randomized clinical trials. Efforts to include endpoints shown to impact value, such as QoL, into clinical trials are warranted. [Table: see text]

scholarly journals The Skin in Celiac Disease Patients: The Other Side of the Coin

Medicina ◽  
2019 ◽  
Vol 55 (9) ◽  
pp. 578 ◽  
Author(s):  
Ludovico Abenavoli ◽  
Stefano Dastoli ◽  
Luigi Bennardo ◽  
Luigi Boccuto ◽  
Maria Passante ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Celiac Disease ◽  
Skin Diseases ◽  
Case Reports ◽  
Case Series ◽  
The Other ◽  
Gluten Free ◽  
Controlled Clinical Trials ◽  
Cutaneous Manifestations ◽  
Small Intestinal

Celiac disease (CD) is an autoimmune enteropathy that primarily affects the small intestine and is characterized by atrophy of intestinal villi. The manifestations of the disease improve following a gluten-free diet (GFD). CD is associated with various extra-intestinal diseases. Several skin manifestations are described in CD patients. The present paper reviews all CD-associated skin diseases reported in the literature and tries to analyze the pathogenic mechanisms possibly involved in these associations. Different hypotheses have been proposed to explain the possible mechanisms involved in every association between CD and cutaneous manifestations. An abnormal small intestinal permeability seems to be implicated in various dermatological manifestations. However, most of the associations between CD and cutaneous diseases is based on case reports and case series and a few controlled studies. To better assess the real involvement of the cutaneous district in CD patients, large multicentric controlled clinical trials are required.

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