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 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 Convalescent Plasma Therapy in COVID 19 an Indian Scenario: Comprehensive Review

2021 ◽  
pp. 453-465
Author(s):  
Shruti Vimal ◽  
Pratiksha Naval ◽  
Manoj Sawadker ◽  
Pallavi Bhomia ◽  
Neha Jadhav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Neutralizing Antibodies ◽  
Clinical Symptoms ◽  
Scientific Data ◽  
Plasma Transfusion ◽  
Eligibility Criteria ◽  
Plasma Therapy ◽  
Comprehensive Review ◽  
Proof Of Efficacy ◽  
Indian Scenario

The recent pandemic due to Corona virus more popularly known as COVID 19 has reassessed the usefulness of historic convalescent plasma transfusion. (CPT) The CPT is one of the promising therapies in the current pandemic situation. This review was conducted to evaluate the effectiveness of CPT therapy in COVID 19 patients based on the publications reported till date. PubMed, EMBASE and Medline databases were screened up to 30 April 2021. All the records were screened as per the protocol eligibility criteria.  The main features of the studies reviewed were, convalescent plasma can reduce mortality in severely ill patients, an increase in neutralizing antibodies titre and disappearance of SARS CoV 2 RNA was observed in all the patients on CPT therapy and over all a beneficial effect on clinical symptoms after administration of CP.  Based on the review findings and the limited scientific data, CPT therapy in COVID 19 patients appear safe, clinically effective and reduces mortality. However, the need of a multicentre clinical trials, unequivocal proof of efficacy, effectiveness and the need for the standardisation of the CPT needs to be addressed immediately for the full utilisation of potential of CPT.

Palliative whole brain radiation therapy (WBRT) for brain metastases (BM) revisited: The patient population in the modern era is different from the original patient cohort of the RTOG WBRT clinical trials

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1544-1544 ◽  
Author(s):  
S. RushM. Savetsky ◽  
A. Vinokur ◽  
N. Mehta
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Surgical Resection ◽  
Systemic Therapy ◽  
Clinical Symptoms ◽  
Retrospective Chart Review ◽  
Whole Brain Radiation ◽  
Oncology Practice ◽  
The Impact ◽  
Modern Era

1544 Background: RTOG trials in the 1970’s established WBRT (3000 cGy/10 fractions) as an effective palliative tool for symptomatic BM. This was in the era before CT/ MRI and effective systemic therapy. Inclusion criteria was based on clinical symptoms, and studies such as EEG and arteriography though not required. This study was undertaken to determine if pts. in the modern era are similar to those aforementioned, since it may not be appropriate to use accelerated WBRT (aWBRT) in these pts. based on the RTOG guidelines if the cohorts are different. (Other issues such as delayed cognitive dysfunction, alopecia and the impact of and integration with systemic therapy are pertinent to the application and prescription of aWBRT, but not the focus of this study). Methods: A retrospective chart review of 414 consecutive pts. with BM treated with radiation therapy in a single practice from 1990 through 2004 form the basis of this study. There were 256 females and 158 males. Lung cancer was the most common primary site (249/60%) and breast cancer next (75/18%). 121 pts (29%) had a single brain metastsis. 66 symptomatic patients underwent surgical resection of a brain metastasis prior to WBRT. The use of CT or MRI was determined. Results: Of the 414 pts, 105 were asymptomatic (25%). An additonal 66 pts. were rendered asymptomatic with surgical resection. Therefore, a total of 171 (40%) pts. were asymptomatic. All pts underwent imaging with CT (132) or MRI (282). Conclusions: Many pts. with BM seen in a modern radiation oncology practice are different from those in the RTOG series’ in which pts. were designated to receive aWBRT. 1. A notable proportion (40%) of a large number of pts. treated since 1990 for BM was asymptomatic vs. none of the pts. in the RTOG trials. 2. All pts. in this series underwent direct imaging vs. none in the RTOG series’. The systematic prescription of aWBRT for all pts. with BM as dictated by RTOG studies in the 1970’s may not be appropriate and alternative strategies and clinical trials are warranted. No significant financial relationships to disclose.

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.

The Effect of Qigong Exercise on Immunity and Infections: A Systematic Review of Controlled Trials

2012 ◽  
Vol 40 (06) ◽  
pp. 1143-1156 ◽  
Author(s):  
Chong-Wen Wang ◽  
Siu-Man Ng ◽  
Rainbow T.H. Ho ◽  
Eric T.C. Ziea ◽  
Vivian C.W. Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Infectious Diseases ◽  
Clinical Evidence ◽  
Clinical Symptoms ◽  
Controlled Trials ◽  
Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Induced Immunity ◽  
Quality Of Research

The objective of this review was to summarize and critically evaluate the clinical evidence of the effect of qigong exercise on immunity and its efficacy in the prevention or treatment of infectious diseases. Thirteen databases were searched from their respective inceptions through January 2011, and all controlled clinical trials of qigong exercise on immunity and infections were included. Quality and validity of the included studies were evaluated using standard scales. Seven studies including two randomized controlled trials (RCTs), two controlled clinical trials (CCTs) and three retrospective observational studies (ROSs) met the inclusion criteria. One study focused on functional measures of immunity (antigen-induced immunity) and six studies on enumerative parameters of immunity. No study on clinical symptoms relevant to infectious diseases could be identified. Overall, the included studies suggested favorable effects of qigong exercise on immunity, but the quality of research for most of the studies examined in this review was poor. Further rigorously designed studies are required, which should adhere to accepted standards of methodology for clinical trials.

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