scholarly journals BCG Vaccination: A Beacon Of Hope With A Word Of Caution – An Overview On The Current Consensus In ncovid-19

2020 ◽  
Vol 7 (05) ◽  
pp. 4810-4821
Author(s):  
Arun Gulati ◽  
Talagavadi Channaiah Anudeep ◽  
Madhan Jeyaraman ◽  
Sushmitha ES ◽  
Arunabh Arora ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vaccination Policy ◽  
Immunization Policy ◽  
Bcg Vaccination ◽  
Mild Disease ◽  
Proven Efficacy ◽  
Containment Strategy ◽  
The Difference ◽  
Vaccines For Children ◽  
Positive Outlook

The world is witnessing a great toll on human lives and economy due to nCOVID-19 pandemic. The newly emerged strain (SARS-CoV-2) is spreading rampantly with no regional barriers. No proven vaccination or a proven drug exist to pulverize SARS-CoV-2. Few studies have linked BCG vaccination policy to account for the difference in nCOVID-19 morbidity and mortality between countries experiencing an avalanche in comparison to those with moderate to mild disease. Apart from its prime discovery for combating TB infection, BCG vaccination holds a wide array of clinical utility because of its immunomodulatory potential. This serves as a ray of hope for extrapolating its use in nCOVID-19 with greater and earliest response. However, at present, it is wrapped with a fear of overutilization without proven efficacy against this contagion and may further result in a shortage of vaccines for children who are covered under immunization policy. A number of clinical trials are underway to enlighten upon BCG and its effectivity parameters to combat this scenario. These outcomes will surely be more significant for countries not following universal vaccination policy. In the interim, containment strategy along with supportive care is the mainstay to battle the prevailing scenario with a positive outlook on the results of ongoing clinical trials.

scholarly journals Does BCG protect against SARS-CoV-2 infection ?: elements of proof

2020 ◽  
Author(s):  
Yassine Ouanes ◽  
Mokhtar Bibi ◽  
Nesrine Baradai ◽  
Marouane Boukhris ◽  
Kays Chaker ◽  
...  
Keyword(s):  
Low Income ◽  
Specific Effect ◽  
Lower Mortality ◽  
Low Income Countries ◽  
Vaccination Policy ◽  
Exclusion Criteria ◽  
Immunization Policy ◽  
Bcg Vaccination ◽  
The World Bank ◽  
The Difference

ABSTRACTBackgroundThere are several factors explaining the difference in the spread of SARS-CoV-2 infection including the BCG vaccination. This fact is supported by the concept of beneficial non specific effect of this live vaccine associated to its interaction with the immune system.Our study aims to identify the correlation between the universal BCG vaccination policy and the mortality attributed to COVID-19.MethodsWe conducted an epidemiological study in which we collected COVID-19 pandemic data of April 11th, 2020 from the web site worldometers.info. The exclusion criteria for our study were a number of inhabitants less than one million, low-income countries according to the World Bank classification, a total number of infection cases less than 500 and countries that have performed less than one hundred tests per million inhabitants.ResultsCountries that never had universal BCG vaccination policy have a higher mortality (correlated to performed diagnostic tests) attributed to SARS-CoV-2 infection (p<0.001).We found that the year of introduction of vaccination influenced significantly the mortality. Countries that started immunization policy before 1960 had more favorable results (p=0.049).For countries that started the BCG vaccination after 1960, countries with current policies have lower mortality attributed to SARS-CoV-2 infection than countries that have stopped immunization (p=0.047).ConclusionsCountries that have a BCG vaccination policy have a lower mortality attributed to SARS-CoV-2 infection. The populations of countries that applied this immunization before 1960 are more protected even if this universal policy has been interrupted.

Explore the Possible Impact of BCG Vaccination Policy on the Morbidity, Mortality, and Recovery Rates due to COVID-19 Infection. (Preprint)

2020 ◽  
Author(s):  
Yue-Cune Chang
Keyword(s):  
Odds Ratio ◽  
Randomized Clinical Trials ◽  
Vaccination Policy ◽  
Bacille Calmette Guerin ◽  
Recovery Rates ◽  
Bcg Vaccination ◽  
The World ◽  
New Form ◽  
The Relationship ◽  
Disease Specific

BACKGROUND The Coronavirus Disease-19 (COVID-19) is the new form of an acute infectious respiratory disease and has quickly spread over most continents in the world. Recently, it has been shown that Bacille Calmette-Guerin (BCG) might protect against COVID-19. This study aims to investigate the possible correlation between BCG vaccination and morbidity/mortality/recovery rate associated with COVID-19 infection. OBJECTIVE Our findings confirm that the BCG vaccination might protect against COVID-19 virus infection. METHODS Data of COVID-19 confirmed cases, deaths, recoveries, and population were obtained from https://www.worldometers.info/coronavirus/ (Accessed on 12 June, 2020). To have meaningful comparisons among countries’ mortality and recovery rates, we only choose those countries with COVID-19 infected cases at least 200. The Poisson regression and logistic regression were used to explore the relationship between BCG vaccination and morbidity, mortality and recovery rates. RESULTS Among those 158 countries with at least 200 COVID-19 infected cases, there were 141 countries with BCG vaccination information available. The adjusted rates ratio of COVID-19 confirmed cases for Current BCG vaccination vs. non-Current BCG vaccination was 0.339 (with 95% CI= (0.338,0.340)). Moreover, the adjusted odds ratio (OR) of death and recovery after coronavirus infected for Current BCG vaccination vs. non-Current BCG vaccination were 0.258 (with 95% CI= (0.254,0.261)) and 2.151 (with 95% CI= (2.140,2.163)), respectively. CONCLUSIONS That data in this study show the BCG might provide the protection against COVID-19, with consequent less COVID-19 infection and deaths and more rapid recovery. BCG vaccine might bridge the gap before the disease-specific vaccine is developed, but this hypothesis needs to be further tested in rigorous randomized clinical trials. INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1101/2020.06.14.20131268

scholarly journals Estimating and reporting treatment effects in clinical trials for weight management: using estimands to interpret effects of intercurrent events and missing data

2021 ◽  
Author(s):  
Sean Wharton ◽  
Arne Astrup ◽  
Lars Endahl ◽  
Michael E. J. Lean ◽  
Altynai Satylganova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Weight Management ◽  
Treatment Effect ◽  
Repeated Measures ◽  
Treatment Effects ◽  
Randomized Clinical Trials ◽  
Weight Losses ◽  
The Difference ◽  
Treatment Of Obesity

AbstractIn the approval process for new weight management therapies, regulators typically require estimates of effect size. Usually, as with other drug evaluations, the placebo-adjusted treatment effect (i.e., the difference between weight losses with pharmacotherapy and placebo, when given as an adjunct to lifestyle intervention) is provided from data in randomized clinical trials (RCTs). At first glance, this may seem appropriate and straightforward. However, weight loss is not a simple direct drug effect, but is also mediated by other factors such as changes in diet and physical activity. Interpreting observed differences between treatment arms in weight management RCTs can be challenging; intercurrent events that occur after treatment initiation may affect the interpretation of results at the end of treatment. Utilizing estimands helps to address these uncertainties and improve transparency in clinical trial reporting by better matching the treatment-effect estimates to the scientific and/or clinical questions of interest. Estimands aim to provide an indication of trial outcomes that might be expected in the same patients under different conditions. This article reviews how intercurrent events during weight management trials can influence placebo-adjusted treatment effects, depending on how they are accounted for and how missing data are handled. The most appropriate method for statistical analysis is also discussed, including assessment of the last observation carried forward approach, and more recent methods, such as multiple imputation and mixed models for repeated measures. The use of each of these approaches, and that of estimands, is discussed in the context of the SCALE phase 3a and 3b RCTs evaluating the effect of liraglutide 3.0 mg for the treatment of obesity.

CLINICAL TRIALS IN INFANTS OF ORALLY ADMINISTERED ATTENUATED POLIOMYELITIS VIRUSES

PEDIATRICS ◽  
1959 ◽  
Vol 23 (6) ◽  
pp. 1041-1062
Author(s):  
Stanley Alan Plotkin ◽  
Hilary Koprowski ◽  
Joseph Stokes
Keyword(s):  
Clinical Trials ◽  
Fecal Excretion ◽  
Jackson Type ◽  
Poliomyelitis Virus ◽  
Minor Illness ◽  
The Difference ◽  
Antibody Levels ◽  
Type 3

Forty-six infants, ranging from less than 1 day to 6 months of age, were given more than 100 feedings of living, attenuated poliomyelitis viruses without the occurrence of major or minor illness. The strains used were CHAT (type 1), Wistar (type 1), Jackson (type 2), P-712 (type 2) and Fox (type 3). All strains except the Jackson strain were found to be antigenic on oral administration. Response to vaccination was demonstrated in these infants by the presence after vaccination of antibody levels significantly in excess of those attributable to transplacentally acquired antibodies, and by the detection of fecal excretion of poliomyelitis virus. Infants less than 2 months old were more difficult to immunize than older infants. The evidence suggests that biologic immaturity rather than transplacental antibodies caused the difference. When the three types of poliomyelitis virus were fed at 3-week intervals, responses occurred to all types. No interference between types was observed when they were fed in all possible sequences. Three infants given a second feeding of homotypic, attenuated poliomyelitis virus 3 to 5 months after a successful vaccination showed resistance to intestinal reinfection.

scholarly journals Review of the efficacy of placebo in comparative clinical trials between typical and atypical antipsychotics

2009 ◽  
Vol 31 (1) ◽  
pp. 52-56 ◽  
Author(s):  
Irismar Reis de Oliveira ◽  
Paulo Menezes Nunes ◽  
Domingos Macedo Coutinho ◽  
Eduardo Pondé de Sena
Keyword(s):  
Clinical Trials ◽  
Atypical Antipsychotic ◽  
Atypical Antipsychotics ◽  
Rating Scale ◽  
Study Drug ◽  
Typical Antipsychotic ◽  
The Difference ◽  
Psychiatric Rating Scale ◽  
Efficacy Parameters ◽  
Typical Antipsychotics

OBJECTIVE: To review the efficacy of placebo in comparison with atypical and typical antipsychotics for the treatment of schizophrenia and schizoaffective disorder and to evaluate the pertinence of using placebo in clinical trials with antipsychotics. METHOD: Trials in which the atypical antipsychotics were compared with typical antipsychotics and placebo were included. A search was conducted using the terms "amisulpride", "aripiprazole", "clozapine", "olanzapine", "quetiapine", "risperidone", "sertindole", "ziprasidone" and "zotepine". Main efficacy parameters were calculated using the proportion of "events" (defined as a deterioration or lack of improvement by at least 20% in Positive and Negative Syndrome Scale or Brief Psychiatric Rating Scale) and the pooled relative risk with random effects, with their respective 95% confidence intervals. We also calculated the necessary sample sizes in studies in which the study drug is compared to a typical antipsychotic or placebo. RESULTS: The pooled efficacy rates observed were 40.8%, 34.9% and 21.3% for the atypical antipsychotics, typical antipsychotics and placebo, respectively. One hundred and sixty six patients would have to be included when a new drug is compared with placebo if calculation is based on a difference of 20% found between the atypical antipsychotic and placebo and 2,054 if the difference sought were that found between the atypical antipsychotic and the typical antipsychotic, i.e. 6%. The estimated therapeutic failures would be 115 of the 166 patients when the study drug is compared with placebo, and 1,274 failures in the 2,054 patients when the study drug is compared to the typical antipsychotic. CONCLUSIONS: Placebo controlled studies may reduce the number of individuals exposed to the harmful effects of ineffective drugs.

scholarly journals BCG vaccination policy and preventive chloroquine usage: do they have an impact on COVID-19 pandemic?

2020 ◽  
Vol 11 (7) ◽  
Author(s):  
Abhibhav Sharma ◽  
Saurabh Kumar Sharma ◽  
Yufang Shi ◽  
Enrico Bucci ◽  
Ernesto Carafoli ◽  
...  
Keyword(s):  
Vaccination Policy ◽  
Bcg Vaccination

P070 TRENDS AND CHARACTERISTICS OF CLINICAL TRIALS PARTICIPATION IN THE IBD PARTNERS COHORT

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S11-S12
Author(s):  
Cole Johnson ◽  
Edward Barnes ◽  
Xian Zhang ◽  
Millie Long
Keyword(s):  
Clinical Trials ◽  
Controlled Trial ◽  
Severe Disease ◽  
Drug Approval ◽  
Cross Sectional Study ◽  
Participation Rates ◽  
Cross Sectional ◽  
Mild Disease ◽  
Randomized Controlled ◽  
Study Results

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCT) for inflammatory bowel disease (IBD) which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors which could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an interventional randomized controlled trial (RCT) of a medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated an in RCT during each calendar year from 2011–2018 and Clinicaltrials.gov was accessed to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1,116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation (Table 1) included following at an academic institution (OR=1.8; 95%CI: 1.51–2.04) and age 36–75 (OR=1.6; 95%CI: 1.43–1.87). Patients with Crohn’s disease (CD) were more likely to participate than those with ulcerative colitis (UC) (OR=1.5; 95%CI: 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR=2.6; 95%CI: 2.19–2.99), IBD-related surgery (OR=2.5; 95%CI: 2.24–2.87), biologic exposure (OR=3.2; 95%CI: 2.76–3.65), and “Poor” or worse quality of life (OR=1.7; 95%CI: 1.45–1.93). Steroid-free remission was associated with lower likelihood of RCT participation (OR=0.6; 95%CI: 0.53–0.70). While the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort (Figure 1). Conclusions RCT participation rates declined within this cohort between 2011–2018. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean sCDAI and SCCAI scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-TNF exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

scholarly journals Changes in BCG Vaccination Policy Should Consider the Effect on Child Health: Table 1.

2015 ◽  
Vol 212 (8) ◽  
pp. 1341-1342 ◽  
Author(s):  
Sanne M. Thysen ◽  
Peter Aaby ◽  
Christine S. Benn ◽  
Ane B. Fisker
Keyword(s):  
Child Health ◽  
Vaccination Policy ◽  
Bcg Vaccination

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

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