Pediatric Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Clinical Characteristics and Cycle Threshold Value (CT value) of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) of Nasopharyngeal Samples

Introduction: We aimed to characterize epidemiological and clinical characteristics of children and adolescents with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and to evaluate relationship of cycle threshold value (CT value) of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test (As surrogate marker of viral load) with patient age and severity of infection. Method(s): We retrospectively collected data of children and adolescents admitted in our center from April 2020 to July 2020 with positive RT-PCR test for SARS-CoV-2. Result(s): Total 62 children, with median (IQR) of age 96 (54-122) months and 39 adolescents with median (IQR) of age 19.5 (18.2-20) years were included. 56 (90%) children and 34 (87%) adolescents had history of SARS-CoV-2 positive cases in their family. Only nine (14%) children had associated risk factor for severe SARS-CoV-2 infection. Fever was the commonest symptom which was present in 24 (39%) children and 16 (41%) adolescents. Cough was present in 17 (27%) children and 10 (26%) adolescents. Diarrhea was found in 14 (23%) children and three (8%) adolescents. CT values of RT-PCR test were similar in children and adolescence (p = 0.48). However, asymptomatic children had higher CT values than symptomatic children (p = 0.01). Conclusion(s): Majority of children have asymptomatic or mild SARS-CoV-2 infection with similar CT values in children and adolescents.Copyright © 2022 by author(s).

EU-PEARL: Changing the paradigm of clinical trials in Europe

Issue Recently, innovative clinical trial designs have been proposed, which have the potential to revolutionize clinical research. Whereas classical trials mostly evaluate only one investigational drug, platform trials embed various trials under a shared master protocol to enable the evaluation of multiple interventions for a disease or condition. Platform trials have mostly been used to evaluate cancer therapies, but also recently for COVID-19. The EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project aims to expand the use of platform trials as the backbone of drug development. Description of Issue EU-PEARL is a Innovative Medicines Initiative 2 Joint Undertaking funded project (2019-2023), and a strategic public and private sector alliance, which aims to support the transformation of the classical trial approach into a cross-company collaborative, multi-compound platform, centred around patients, not diseases. How to operationalize and sustain this? A multi-stakeholder, mixed-methods approach is taken, focused around the concept of an integrated research platform (IRP), i.e., a common enabling framework for platform trials. The IRP will be established as a sustainable and scalable global solution, consisting of an infrastructure, workflows, and guidance on how to meet complex regulatory, ethical, legal, statistical and data requirements. Lessons from COVID-19 trials will be incorporated. Results A disease-agnostic IRP is being developed, as well as four disease specific IRPs in four areas of high public health relevance, i.e. major depressive disorder, tuberculosis, non-alcoholic steatohepatitis, and neurofibromatosis. Lessons Multi-stakeholder, multi-sector and multi-disciplinary collaborations are challenging in practice, but rewarding in outcomes. Given the complexity of setting-up these novel trials, clear communication and standardized terminology must be established, as well as continual awareness building of their components, challenges and benefits. Key messages EU-PEARL intends to stage the clinical trials of the future, which will be more adaptive, efficient and patient-centred by design and outcome. EU-PEARĹs efforts aim to contribute to timely societal access to affordable medicines and address unmet health needs.

Comparison of effectiveness of chlorine dioxide mouthwash and chlorhexidine gluconate mouthwash in reduction of oral viral load in patients with covid-19

Background: Air-borne droplets constitute the main route of transmission of COVID-19. Considering the exponential increase in number of cases, it has become the need of the hour to develop additional measures to limit the spread of infection. Materials and Methods: 40 patients were provided with Chlorhexidine gluconate (0.2%) mouthwash and Chlorine dioxide (0.1%) mouthwash to rinse and gargle thrice a day for one week. The qualitative COVID antigen test confirmed by Qualitative PCR on an oropharyngeal swab collected from the patients was compared for both the groups at baseline and post-intervention levels. Results: There was an improvement in symptoms such as cough, sore throat and bad breath in both the groups. The number of cases demonstrating reduction in intensity of symptoms as well as testing qualitatively negative for COVID-19 antigen were found to be greater in the group that was provided with Chlorine dioxide mouthwash. Conclusion: Regular use of Chlorine dioxide could effectively reduce the symptoms and oral viral load, thereby subsequently reducing the symptoms and risk of transmission of COVID-19. Use of Chlorine dioxide mouthwash may be recommended as a part of health policies and preprocedural protocols.

Does PCR Cycle Threshold for SARS-CoV-2 have Association with ABO Blood Group Types?

Introduction: Corona Virus Disease-19 (COVID-19) caused by the Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) has led to a global pandemic. Currently, the standard method for the diagnosis of COVID-19 is the detection of SARS-CoV-2 by Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR). Lower Cycle threshold (Ct) value of PCR is found to be associated with increased probability of progression to severe disease and infectivity. Blood group A individuals have been found to be more susceptible to infection by SARS-CoV-2 while that of O blood group have lower risk of infection. There has been growing scientific interest to obtain data which may characterise the susceptibility to COVID-19 infection and determine the risk factors which may be associated with progression and severity of the disease. Aim: To study the association of RT-qPCR Ct values for SARS-CoV-2 with ABO blood group types. Materials and Methods: A prospective observational study was conducted at tertiary care centre in western Maharashtra, India where in a total of 116 symptomatic admitted patients between mid-July to mid August 2020 and was found to be positive for SARS-CoV-2 by RT-qPCR were enrolled in the study. Ct values for pan-Sarbecovirus E-gene and SARS-CoV-2 specific RdRP gene were recorded for each patient. In addition, all the patients were typed for ABO blood grouping. Distribution of different ABO blood group types in SARS-CoV-2 positive patients were analysed and was compared with blood groups in 882 non-COVID-19 blood donors comprising control group. Ct values for E and RdRP gene were also analysed in respect to different age group, gender and blood group types. Blood group records of voluntary healthy blood donors reporting at our centre between September to November 2019 were obtained. Results: Of the 116 patients, 33 (28.45%) comprised of type A, 34 (29.31%) of type B, 41 (35.34%) were of type O and remaining 8 (6.90%) had AB blood group type. Compared to the control group, no significant difference was noted in the distribution of ABO blood types in SARS-CoV-2 positive patients. Also, no statistical significance was found in the Ct values with respect to age, gender and different ABO blood group types. Conclusion: RT-qPCR Ct values for SARS-CoV-2 infection have no association with ABO blood group types.