Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

Screening COVID-19 by Swaasa AI platform using cough sounds: a cross-sectional study.

The Advent of Artificial Intelligence (AI) has led to the use of auditory data for detecting various diseases, including COVID-19. SARS-CoV-2 infection has claimed more than six million lives to date and therefore, needs a robust screening technique to control the disease spread. In the present study we created and validated the Swaasa AI platform, which uses the signature cough sound and symptoms presented by patients to screen and prioritize COVID-19 patients. We collected cough data from 234 COVID-19 suspects to validate our Convolutional Neural Network (CNN) architecture and Feedforward Artificial Neural Network (FFANN) (tabular features) based algorithm. The final output from both models was combined to predict the likelihood of having the disease. During the clinical validation phase, our model showed a 75.54% accuracy rate in detecting the likely presence of COVID-19, with 95.45% sensitivity and 73.46% specificity. We conducted pilot testing on 183 presumptive COVID subjects, of which 58 were truly COVID-19 positive, resulting in a Positive Predictive Value of 70.73%. Due to the high cost and technical expertise required for currently available rapid screening methods, there is a need for a cost-effective and remote monitoring tool that can serve as a preliminary screening method for potential COVID-19 subjects. Therefore, Swaasa would be highly beneficial in detecting the disease and could have a significant impact in reducing its spread.

Development and clinical validation of Swaasa AI platform for screening and prioritization of pulmonary TB.

Acoustic signal analysis has been employed in various medical devices. However, studies involving cough sound analysis to screen the potential pulmonary tuberculosis (PTB) suspects are very few. The main objective of this cross-sectional validation study was to develop and validate the Swaasa AI platform to screen and prioritize at risk patients for PTB based on the signature cough sound as well as symptomatic information provided by the subjects. The voluntary cough sound data was collected at Andhra Medical College-India. An Algorithm based on multimodal convolutional neural network architecture and feedforward artificial neural network (tabular features) was built and validated on a total of 567 subjects, comprising 278 positive and 289 negative PTB cases. The output from these two models was combined to detect the likely presence (positive cases) of PTB. In the clinical validation phase, the AI-model was found to be 86.82% accurate in detecting the likely presence of PTB with 90.36% sensitivity and 84.67% specificity. The pilot testing of model was conducted at a peripheral health care centre, RHC Simhachalam-India on 65 presumptive PTB cases. Out of which, 15 subjects truly turned out to be PTB positive with a positive predictive value of 75%. The validation results obtained from the model are quite encouraging. This platform has the potential to fulfil the unmet need of a cost-effective PTB screening method. It works remotely, presents instantaneous results, and does not require a highly trained operator. Therefore, it could be implemented in various inaccessible, resource-poor parts of the world.

Community Dynamics and Engagement Strategies in Establishing Demographic Development and Environmental Surveillance Systems: A Multi-Site Report from India.

BACKGROUND: Six diverse Demographic Development and Environmental Surveillance System (DDESS) sites were established in urban slum, urban resettlement, peri-urban, rural, and tribal areas located in Northern, North-East, Eastern, and Southern regions of India from June 2020 to March 2022. Understanding the community dynamics and engaging people in the community is critically important in the process of establishing DDESS. We ascertained the barriers, challenges, and facilitators during the establishment of multiple DDESS sites across India. METHODS: This was a cross-sectional descriptive mixed-methods study. RESULTS: Multiple barriers and challenges encountered were reported in the process of community engagement (CE), such as geographical inaccessibility, language barriers, adverse weather, non-responsiveness due to perceived lack of individual benefit or financial gain, fear of contracting COVID-19, COVID-19 vaccine hesitancy, etc. Facilitators in the CE process were pre-existing links with the community, constitution of community advisory boards, community need assessment, concomitant delivery of outreach health services, and skill-building facilities. CONCLUSION: Most community barriers in the development of DDESS sites in resource-limited settings can be overcome through a multipronged approach, including effective community engagement by focusing on demonstrating trust at the local level, enlisting community mobilization and support, utilizing pre-existing community linkages, initiating community diagnosis, and meeting perceived community health needs.

Multiple-choice questions in assessment: Perceptions of medical students from low-resource setting.

BACKGROUND: In curriculum reforms under Competency-Based Medical Education (CBME) introduced by the National Medical Commission, medical students are recognized as one of the stake holders. The well-designed multiple-choice questions (MCQs) help students in assessment as well as promote deep learning. The objective of this study is to assess the perceptions of the Indian medical students towards the examination patterns in their undergraduate curriculum with particular reference to MCQs. MATERIALS AND METHODS: An observational cross-sectional study was conducted among the medical colleges in India. A total of 7875 students took part in the study. The study instrument was a validated pretested self-administered questionnaire. The study was conducted as an online survey using the Google Forms platform. Inclusion criteria were students from all professional years as well as interns and those who were willing to participate in the study. RESULTS: For the question of initiation of MCQs as a tool for the assessment, many of the students (46%) expressed that it should start from the 1st MBBS itself. The majority of the students (85%) felt that MCQ oriented preparation will be helpful for MBBS professional (theory and practical) examinations. Most of the students (90.9%) preferred that the MCQs should be concept and case scenario based. To the question of whether the current system of the university theory examinations of essays and short notes be replaced in total with MCQs so that they are more prepared for NEXT and USMLE examination, 65.5% responded with an answer of yes. CONCLUSION: The findings of this study provide input to the regulatory authorities and other stakeholders responsible for designing and implementing the medical curriculum.

A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India.

BACKGROUND: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. METHODS: This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170. FINDINGS: 1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78-1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe. INTERPRETATION: SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals. FUNDING: SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.

High Prevalence of CKD of Unknown Etiology in Uddanam, India.

INTRODUCTION: There were concerns raised regarding a high prevalence of chronic kidney disease (CKD) in Uddanam, a fertile subtropical low-altitude territory in the southern Indian state of Andhra Pradesh. The present study was undertaken to ascertain the prevalence of CKD, disease characteristics, and risk factor profile in this area. METHODS: We selected 2210 subjects (age >18 years) using multistage sampling. After obtaining demographic and anthropometric data, urinary protein-creatinine ratio, serum creatinine, and blood glucose were measured in all the subjects. Glomerular filtration rate was estimated (eGFR) using the Modification of Diet in Renal Disease equation. RESULTS: Mean age of the subjects was 43.2 ± 14.2 years (range: 18-98), 44.3% were men and 55.7% were women. Mean eGFR of subjects was 94.3 ± 33.4. Low eGFR (<60 ml/min per 1.73 m2) was seen in 307 (13.98%) patients with a mean eGFR of 34.8 ± 16.6. The prevalence of subjects having low eGFR and with proteinuria (CKD) was 18.23%. Major risk factors, such as diabetes, long-standing hypertension, and significant proteinuria, were absent in 73% of patients with CKD, implying that a significant proportion of the population is afflicted with the entity "CKD of unknown etiology (CKDu)." CONCLUSION: The prevalence of CKD and CKDu in Uddanam is much higher than other earlier studies in either rural or urban communities in India. We suggest that there is a dire need to review health policies and allocate resources for prevention and treatment of CKD in the Uddanam region.