SARS-CoV-2 Antibody Response Following COVID-19 Vaccination, a Longitudinal Study.

Background: The objective was studying the antibody response following immunization with COVID-19 vaccines. Material and Methods: It was a longitudinal study of healthcare workers (HCWs). Two groups were taken, Group 1 had taken first dose of the COVID-19 vaccine, at least 3 weeks have passed. Group 2 had taken two doses of COVID-19 vaccine and at least 2 weeks have passed. A quantitative test for antibodies to SARS-CoV-2 spike protein was done. Follow-up of both groups was done after 3 months of collection of the first sample. Results: The antibody titre of the 57 HCWs in Group 1, decreased significantly 125 days after the first dose [median = 2,013 U/ml] as compared to the titre 30 days after the first dose of Covishield vaccine[median = 9,965.26 U/ml]. The median interval between two doses of vaccine was 34 days. In Group 2, the antibody titre of the 60 HCWs in Group 2, decreased significantly 114 days after second dose[median = 1,411 U/ml] as compared to the titre 19.5 days after second dose of Covishield vaccine [median = 2,377.5]. There was no significant difference in the antibody titre in follow-up samples of HCWs with and without side effects. Conclusion: The antibody titre decreases after 13 to 17 weeks post the second dose of Covishield vaccination. The decision of the Government of India to increase the interval between two doses of Covishield is justified. Low antibody titre can be the reason for breakthrough infections. The antibody titre was not related to side effects post-vaccination.

Death analysis of COVID-19 patients admitted in dedicated COVID hospital in Mumbai.

Introduction: COVID-19 poses a great threat globally and also a huge burden on developing countries due to its expensive, less effective, and toxic treatment. India is one of the countries with large number of confirmed cases. This study is done to assess the death due to COVID-19 on various parameters so that necessary action can be taken to reduce the disease burden of COVID-19. Aim and Objective: I) To find sociodemographic and other factors associated with mortality. II) To study various comorbidities related to the death due to COVID-19 infection. III) Recommendation for reducing mortality in COVID-19 patients. Material and Method: Data related to COVID-19 death was taken from MRD (Medical Record Department) & e-Health records from HMIS and was analyzed by Bivariate analysis in SPSS. Results: Results showed that people with 1--2 comorbidity have 62% death. Mortality was found to be more in elderly, that is, >60 years age group with 67.5% of total mortality. And in males (68.6%) as compared to female. Conclusion: People with comorbidities have significant association. Also, it showed that death was more common in male and elderly age group as compared to female and youngsters.

To Study Adverse Effect following Immunization (AEFI) and COVID-19 Infection amongst COVID-19 Vaccine Benefeciaries.

COVID-19 vaccines have been rolled out recently in several parts of the world. Little is known about the post-vaccination experience outside of clinical trial conditions. The aim of this study was to investigate the adverse effects and infection rate of vaccinated people in a community scenario. It will help to educate the public, dispel misinformation and reduce vaccine hesitancy. AIM AND OBJECTIVES: Assessing total beneficiaries of COVID-19 vaccination and finding among them COVID-19 infection and AEFI after vaccination. SUBJECT AND METHODS: Cross sectional Study at COVID-19 Vaccination centre at DCH in Mumbai, since 1st February2021-31st July 2021, Data was collected by calling telephonically the registered beneficiaries in Vaccination Centre, data was collected and analysed in MS-excel sheet and SPSS using CHI-square test. RESULTS: 49.68% of the beneficiaries were from the age group of 45-60 years followed by >60 years age group (34.70%). 97.08% beneficiaries were from Mumbai. 3593(43.59%) had taken both the doses of COVID-19 vaccine while 4650(56.41%) had taken only first dose of COVID -19 vaccine. 36(0.44%) had contracted COVID-19 infection after vaccination. 88.71% had no AEFI after taking vaccine. 1.65% had mild AEFI 9.63% had moderate AEFI. CONCLUSION: Very few had contracted COVID-19 infection after vaccination. Out of all AEFI maximum were mild to moderate.

An observational study to find association between Hypertension and severe and fatal COVID-19 infection in COVID dedicated hospital, Mumbai.

Introduction: World Health Organization (WHO) has declared COVID-19 outbreak as a "public health emergency of international concern" on January 31, 2020. After that the epidemic spread rapidly around the world. Chronic non-communicable diseases were identified as risk factors for SARS-CoV-2. Hypertension (HTN) is one of the most common cardiovascular diseases with a prevalence ranging from 10% to 20% among adult population. After COVID-19 outbreak, identification of risk factors for severe or fatal disease is necessary to allocate limited resources. For primary care physicians, this is of vital importance to know the association between hypertension and severe and fatal COVID-19 infection as hypertension is affecting millions of people all over the world and primary health care is of immense importance in a country like India. Duration of stay in hospital which will be taken as proxy measure of duration of illness, symptomatic status, need of ICU care and death will be taken as indicators of severe and fatal COVID-19 infection. There are few researches to find an association between Hypertension and severe and fatal COVID-19 infection. There is a need to assess the same. Objectives: To find an association of hypertension and severe and fatal COVID-19 infection. Methodology: A hospital-based cross-sectional study was carried out at a COVID dedicated hospital, Mumbai in 9 months from 1 April 2020 to 31 December 2020. All patients admitted in hospital were included in the study by universal sampling. Ethical Approval: The permission to conduct the study was taken by Institutional Ethics Committee. Results: There was a significant association between hypertension and severe and fatal COVID-19 infection defined by more duration of stay in hospital, admission to ICU and mortality. Conclusions: It is concluded from this study that hypertension is associated with severe and fatal COVID-19 infection. It gives a clear idea for primary care physicians to give more focus towards patients with hypertension with COVID-19 infection. Blood pressure monitoring should be strictly practiced during COVID-like illnesses. Special attention is to be given as far as treatment and early referral to higher centre with ICU is concerned for better outcome. Hypertensive patients should be protected more by adopting COVID appropriate behaviour.

Optimization of Diltiazem hydrochloride osmotic formulation using QBD approach

Abstract Diltiazem hydrochloride (DLH) is a calcium channel blocker useful for the treatment of angina pectoris, arrhythmia, and hypertension. DLH having a short half-life needs frequent administration for successful treatment but this poses a problem of poor patient compliance. These requirements are served by elementary osmotic pump tablets (EOP) based controlled-release (CR) systems. Quality by design (QbD) approach assists in screening various factors with subsequent assessment of critical parameters that can have a major impact on the scalability of EOP. Tablets were formulated using wet granulation method followed by osmotic coating. Factorial design based QbD strategy aided in defining the risk assessment of influential variables such as hydrophilic polymers and osmotic coat component on the in-vitro release kinetics of the designed EOP tablets. These formulated EOP systems followed zero-order kinetics, a characteristic feature of EOPs. EOP tablets were formulated applying a systematic QbD statistical approach. The formulated DLH EOP systems with improved concentration-independent behavior helped to address the challenges of IR formulation. Application of QbD strategy in ascertaining the scalability of DLH EOP formulation would help pharmaceutical industries in the translation of EOP based drug delivery systems from R&D to market.

Epidemiological study to assess the impact of COVID-19 pandemic on the occurrence of monsoon-related diseases in the city of Mumbai.

BACKGROUND: The onset of monsoons in Mumbai poses an additional health disease burden in the form of rising vector-borne and water-borne diseases such as dengue, malaria, leptospirosis, hepatitis, typhoid, chikungunya, and acute gastroenteritis. These monsoon-related illnesses are preventable with hygienic and sanitation measures that are likely to have been adopted during COVID-19 pandemic. AIM: To assess the impact of COVID-19 pandemic on the occurrence of monsoon-related diseases in the city of Mumbai and find out determinants of variations if any. MATERIAL AND METHODS: This was a retrospective descriptive study. Universal sampling was done using secondary data collected from the Epidemiological Cell of Municipal Corporation of Greater Mumbai (MCGM). Data mining was performed to obtain the trends of the monsoon-related diseases in Mumbai. RESULTS: COVID-19 pandemic has remarkably affected the city of Mumbai with approximately 3 lakh cases till December 2020. MCGM has taken a lot of efforts resulting in a recovery rate of close to 95% with less than 3% mortality. With the effective use of social behavior change communication, which focused on masks, frequent hand washing, and social distancing, there seems to be a decline in monsoon-related illnesses in the year 2020 as compared to the previous two years of 2018 and 2019. CONCLUSION: Monsoon-related illnesses are impacted by behavior and lifestyle modifications like hygiene and environmental sanitation practiced during the COVID-19 pandemic. This study highlights the importance of these universal hygienic practices and their utility in the long-term reduction of monsoon-related illnesses.

A comparative cross-sectional analysis on outcomes of Covid-19 patients requiring dialysis.

CONTEXT: Coronavirus Disease 2019 (COVID-19) was declared as a pandemic by the World Health Organization (WHO) on March 11, 2020. COVID-19 disproportionately affects patients with pre-existing comorbidities including those undergoing dialysis at intermittent intervals. These patients requiring renal replacement therapy like intermittent hemodialysis have a preponderance to go into severe clinical states. Hence, this study was planned to analyze the outcomes of such patients requiring dialysis and suffering from the COVID-19 disease. OBJECTIVES: This study was carried out to compare the outcomes of the COVID-19 patients requiring hemodialysis with those not requiring hemodialysis. MATERIALS AND METHODS: This cross-sectional observational study was carried out between April 2020 and August 2020 at a dedicated COVID-19 hospital and included COVID-19 patients requiring hemodialysis at the time of admission and an equal number of controls matched for age and sex. RESULTS: The study included 271 COVID-19-positive patients requiring dialysis and 271 COVID-19-positive controls without the requirement of a dialysis matched for age and sex; 10.3% cases needed intensive care. There were 18.8% deaths in cases as opposed to 8.9% among controls. Multivariate analysis showed that advancing age (OR 2.6 in cases and 1.06 in controls) need for intensive care (OR 27.9 in cases and 331 in controls), and diabetes alone and with other comorbidities were significant predictors of mortality. CONCLUSIONS: This study showed that the mortality proportions were more in cases as compared to controls; and advancing age, diabetes, and need for intensive care unit (ICU) were significant predictors. The study also highlighted the crisis faced by patients who require dialysis at regular intervals due to this COVID-19 pandemic.

Assessment of Risk Factors for COVID-19 in Health Care Workers: A Nested Case-Control Study.

OBJECTIVES: To study the risk factors for SARS-CoV-2 infection in health care workers (HCWs) exposed to COVID-19 patients. MATERIAL AND METHODS: This was a nested case-control study of health care workers(HCWs) in a Dedicated COVID Hospital(DCH). The data collection was done from Dec 2020 to Feb 2021. The study was part of an international multicenter study by the World Health Organisation (WHO).2 The Doctors, nurses, housekeeping staff, clerks, and other staff working in this DCH were considered as HCWs. HCWs working in this DCH with confirmed COVID-19 were recruited as cases and other HCWs working in this DCH in the same Ward/ICU/office without infection were recruited as controls (incidence density sampling). Three controls were taken per case. The questions were in the Likert scale. RESULTS: There were 25 cases and their 75 controls. There was no significant difference between cases and controls with respect to age, sex, occupation, education, and comorbidities and all controls were negative for antibodies at the time of the interview. Most (70%) of the HCWs were doctor by profession followed by nurses (19%). All HCWs were trained in IPC (infection Prevention and Control). Most (96%) HCWs reported that PPE (personal protective equipment) is available in sufficient quantity. There was no significant difference between cases and controls with respect to those having direct contact with the patient's materials, surroundings, and following hand hygiene. CONCLUSION: Adequate availability of PPE, IPC training of HCWs are important for preventing COVID-19 but do not completely reduce risk among HCWs.

A cross-sectional study to screen community health volunteers for hip/knee-osteoarthritis and osteoporosis.

CONTEXT: Osteoarthritis (OA) is a degenerative disease mainly affecting hip and knee joints, and osteoporosis is characterized by diminution of bone mass. Both these diseases have a substantial economic impact on society. Community health volunteers (CHVs) being peripheral health workers are prone to such diseases owing to their sociodemographic and occupational profile. AIM: This study was conducted to estimate the proportion of hip/knee OA and osteoporosis among CHVs and understand determinants of their current bone health status. MATERIALS AND METHODS: Screening for OA was done using a tool adopted from a previous study after obtaining due permissions. Weight, height, blood pressure, and bone mineral density of all participants were recorded. Statistical tests such as Chi-square and multiple logistic regression were used for analysis of data. RESULTS: Out of 80 participants, 50 (62.5%) had increased body mass index (overweight + obese), 10 (12.5%) were hypertensive, 14 (17.5%) CHVs screened positive for hip OA, and 29 (36.3%) were positive for knee OA. Hip OA was associated with advancing age, parity, and obesity. Knee OA was associated with age and exercise. In total, 16.3% subjects were found to have osteoporosis and 61.2% had osteopenia. CONCLUSIONS: This study showed that a remarkable proportion of CHVs had bone and joint problems. CHVs must, therefore, receive preventive measures such as health education and screening for these diseases.