A Double-blind Multicenter Two-arm Randomized Placebo-controlled Phase-III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α1 as an Add-on Treatment to Existing Standard of Care Treatment in Moderate-to-severe COVID-19 Patients.

Background: From an epidemic outbreak, coronavirus disease-2019 (COVID-19) has quickly developed. Thymosin α1 (Tα1) has the ability to boost the T-cell numbers, support T-cell differentiation, maturation, and reduce cell apoptosis. In this study, we have investigated the efficacy and safety of Tα1 in moderate-to-severe COVID-19 patients. Patients and methods: In this double-blind, multicenter, two-arm, randomized, placebo-controlled, phase III clinical study, patients were randomized to receive either Tα1 or placebo in combination with standard of care (SOC). The data on all-cause mortality, clinical progression/deterioration, duration of hospital/intensive care unit (ICU) stay, and safety data were collected. The patients were telephonically followed up on Day 28. Results: A total of (n = 105) COVID-19 patients were included in the study, of which 40 and 65 were severe and moderate, respectively. Thymosin arm (11.1%) had a statistically lower death rate in comparison to the placebo arm (38.5%). A total of 67 adverse events were reported in 42 patients among 105 dosed patients during the study. Among them, 43 adverse events were of mild in nature, 16 adverse events were of moderate in nature, and 8 serious adverse events (death) occurred during the study. Conclusion: This study provides evidence that Tα1 can lower death rate in severe COVID-19 patients, reduce the load on hospitals by shortening the required number of days of hospitalization and help in abbreviating the requirement of oxygen support by positively impacting the recovery rate and time taken for recovery. How to cite this article: Shetty A, Chandrakant NS, Darnule RA, Manjunath BG, Sathe P. A Double-blind Multicenter Two-arm Randomized Placebo-controlled Phase-III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α1 as an Add-on Treatment to Existing Standard of Care Treatment in Moderate-to-severe COVID-19 Patients. Indian J Crit Care Med 2022;26(8):913-919.

Ultraviolet Box: An Innovative In-house Use of Ultraviolet Irradiation for Conservation of Respirators in COVID-19 Pandemic.

AIM: To use ultraviolet (UV) radiations in an indigenous method for sterilization of respirators for reuse during COVID-19 outbreak. BACKGROUND: COVID-19 outbreak has infected more than 200 countries. In India, till now, more than 100,000 cases have been reported. Healthcare workers are at high risk of developing infections being in the frontline of taking care of COVDI-19 cases. The demands of personal protective equipment (PPE) are increasing, but the same is not matched with supply due to various reasons. In such scenarios, reusing respirators and face shields is an alternative. UV radiations have quick action and are able to preserve the quality of respirators. We have developed a UV box for surface sterilization of respirators with an intention to reuse. TECHNIQUE: A thermocol box was taken from the central drug store and was fitted with two UV tubes of 254 nm wavelength procured from local service center of water purifiers. The position of the two tubes was such that one was near the base while other was fixed at the top. An aluminum mesh frame was placed in the middle of the box to act as a platform. The roof of the box was converted into a lid. The effectiveness of assembly was tested using culture of Escherichia coli and Staphylococcus aureus. In addition, a biological indicator tube containing test strip with spores of Bacillus atrophaeus was also exposed to UV light for a predefined duration, which did not show any color change after incubation for 48 hours. CONCLUSION: Our prototype assembly with supported efficacy from microbiological tests is an option for use of UV light within available resources for disinfection and reuse of scarce supplies of personal protective equipment. CLINICAL SIGNIFICANCE: UV box can help in meeting the demand supply deficit for respirators, face shields, and goggles that are paramount for the protection of HCW. HOW TO CITE THIS ARTICLE: Kumar P, Chaudhry D, Parmar A, Tyagi D, BG Manjunath, Singh PK. Ultraviolet Box: An Innovative In-house Use of Ultraviolet Irradiation for Conservation of Respirators in COVID-19 Pandemic. Indian J Crit Care Med 2020;24(8):713-715.

Guidelines for endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA): Joint Indian Chest Society (ICS)/Indian Association for Bronchology (IAB) recommendations.

Over the past decade, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become an indispensable tool in the diagnostic armamentarium of the pulmonologist. As the expertise with EBUS-TBNA has evolved and several innovations have occurred, the indications for its use have expanded. However, several aspects of EBUS-TBNA are still not standardized. Hence, evidence-based guidelines are needed to optimize the diagnostic yield and safety of EBUS-TBNA. For this purpose, a working group of experts from India was constituted. A detailed and systematic search was performed to extract relevant literature pertaining to various aspects of EBUS-TBNA. The modified GRADE system was used for evaluating the level of evidence and assigning the strength of recommendations. The final recommendations were framed with the consensus of the working group after several rounds of online discussions and a two-day in-person meeting. These guidelines provide evidence-based recommendations encompassing indications of EBUS-TBNA, pre-procedure evaluation, sedation and anesthesia, technical and procedural aspects, sample processing, EBUS-TBNA in special situations, and training for EBUS-TBNA.

Statistical inference for distributions with one Poisson conditional.

It will be recalled that the classical bivariate normal distributions have normal marginals and normal conditionals. It is natural to ask whether a similar phenomenon can be encountered involving Poisson marginals and conditionals. However, it is known, from research on conditionally specified models, that Poisson marginals will be encountered, together with both conditionals being of the Poisson form, only in the case in which the variables are independent. In order to have a flexible dependent bivariate model with some Poisson components, in the present article, we will be focusing on bivariate distributions with one marginal and the other family of conditionals being of the Poisson form. Such distributions are called Pseudo-Poisson distributions. We discuss distributional features of such models, explore inferential aspects and include an example of applications of the Pseudo-Poisson model to sets of over-dispersed data.

Persistent müllerian duct syndrome: How to deal with the müllerian duct remnants - a review.

Persistent müllerian duct syndrome (PMDS) is usually a surprise finding either during orchidopexy or during routine inguinal hernia repair in male patients. Often, the surgeon would face a dilemma about what is to be done with the remnants of müllerian duct, i.e. the fallopian tubes, uterus and proximal vagina. Till recently, it was advised to retain these structures whenever it was felt that the complete excision of these structures may jeopardise the blood supply and integrity of the vas deferens. Recent reports of malignancy in these retained structures would justify more aggressive approach. In our patients with PMDS, we have removed the mucosa of the retained müllerian structures, without compromising the integrity and vascularity of the vas deferens, thus reducing the chances of malignancy.