Humoral antibody kinetics with ChAdOx1-nCOV (Covishield™) and BBV-152 (Covaxin™) vaccine among Indian Healthcare workers: A 6-month longitudinal cross-sectional Coronavirus Vaccine-induced antibody titre (COVAT) study.

BACKGROUND AND AIMS: There is limited data available on longitudinal humoral antibody dynamics following two doses of ChAdOx1-nCOV (Covishield™) and BBV-152 (Covaxin™) vaccine against SARS-CoV-2 among Indians. METHODS: We conducted a 6-month longitudinal study in vaccinated healthcare workers by serially measuring quantitative anti-spike antibody at 3-weeks, 3-months and 6-months after the completion of second dose. Geometric mean titer (GMT) and linear mixed models were used to assess the dynamics of antibody levels at 6 months. RESULTS: Of the 481 participants, GMT of anti-spike antibody decreased by 56% at 6-months regardless of age, gender, blood group, body-mass index and comorbidities in 360 SARS-CoV-2 naive individuals but significantly more in hypertensives. Participants with past infection had significantly higher GMT at all time points compared to the naive individuals. Among SARS-CoV-2 naive cohorts, a significantly higher GMT was noted amongst the Covishield recipients at all time points, but there was a 44% decline in GMT at 6-month compared to the peak titer period. Decline in GMT was insignificant (8%) in Covaxin recipients at 6-month despite a lower GMT at all time points vs. Covishield. There was 5.6-fold decrease in seropositivity rate at 6-month with both vaccines. Participants with type 2 diabetes mellitus have a lower seropositivity rate at all the time points. Seropositivity rate was significantly higher with Covishield vs. Covaxin at all time points except at 6-month where Covaxin recipients had a higher seropositivity rate but no difference noted in propensity-matched analysis. CONCLUSIONS: There is waning humoral antibody response following two doses of either vaccine at six months. Covishield recipients had a higher anti-spike antibody GMT compared with Covaxin at all-time points, however a significant decline in antibody titers was seen with Covishield but not with Covaxin at 6-months.

Antibody response after first and second-dose of ChAdOx1-nCOV (CovishieldTM®) and BBV-152 (CovaxinTM®) among health care workers in India: The final results of cross-sectional coronavirus vaccine-induced antibody titre (COVAT) study.

BACKGROUND: We assessed the humoral immune response of both ChAdOx1-nCOV (CovishieldTM) and BBV-152 (CovaxinTM) vaccines in Indian health care workers (HCW). METHODS: A Pan-India, Cross-sectional, Coronavirus Vaccine-induced Antibody Titre (COVAT) study was conducted that measured SARS-CoV-2 anti-spike binding antibody quantitatively, 21 days or more after the first and second dose of two vaccines in both severe acute respiratory syndrome (SARS-CoV-2) naïve and recovered HCW. Primary aim was to analyze antibody response (seropositivity rate, Geometric Mean Titre [GMT] and 95% Confidence Interval [CI]) following each dose of both vaccines and its correlation to age, sex, blood group, body mass index (BMI) and comorbidities. Here we report the results of anti-spike antibody response after first and two completed doses. RESULTS: Among the 515 HCW (305 Male, 210 Female) who took two doses of both vaccines, 95.0% showed seropositivity to anti-spike antibody. However, both seropositivity rate and GMT (95% CI) of anti-spike antibody was significantly higher in Covishield vs. Covaxin recipients (98.1 vs. 80.0%; 129.3 vs. 48.3 AU/mL; both p < 0.001). This difference persisted in 457 SARS-CoV-2 naïve and propensity-matched (age, sex and BMI) analysis of 116 participants. Age > 60-years, males, people with any comorbidities, and history of hypertension (HTN) had a significantly less anti-spike antibody GMT compared to age ≤ 60 years, females, no comorbidities and no HTN respectively, after the completion of two doses of either vaccine. Gender, presence of comorbidities, and vaccine type were independent predictors of antibody seropositivity rate and anti-spike antibody titre levels in multiple logistic and log transformed linear regression analysis. Both vaccine recipients had similar solicited mild to moderate adverse events and none had severe or unsolicited side effects. CONCLUSIONS: Both vaccines elicited good immune response after two doses, although seropositivity rates and GMT of anti-spike antibody titre was significantly higher in Covishield compared to Covaxin recipients.

Admission Blood Glucose but Not HbA1c Predicts Mortality in People with Diabetes Hospitalized with COVID-19 Infection

Background: Previous studies have documented several biochemical, clinical and radiological risk factors for mortality in patients with COVID-19. Early identification of the patients who are most likely to develop critical course will enable informed decisions and shall facilitate the provision of timely supportive treatment in advance and thus may reduce mortality. Methodology: This is a multicentric retrospective study aimed to explore the role of hyperglycaemia (admission blood glucose and HbA1c) in predicting mortality in diabetic patients hospitalised for COVID-19. Results: A total of 133 patient records were analysed retrospectively who were admitted to three tertiary care hospitals between 15/05/2020 to 15/11/2020. Multiple logistic regression indicated that the capillary blood glucose (CBG) on admission was an independent risk factor for mortality in DM patients with COVID-19 (Odds Ratio [OR] = 1.132, 95% confidence interval [CI]: 1.012-1.216), p=0.043 whereas HbA1c failed to predict mortality (Odds Ratio [OR] = 1.119, 95% confidence interval [CI]: 0.981-1.216), p=0.357. The optimal admission CBG level for predicting mortality was 243.50 mg/dL, with an area under the curve (AUC) of 0.879 (95% CI: 0.767-0.990) with a corresponding sensitivity of 88.9 and specificity of 72.7 at this cut-off. As revealed by the receiver-operating characteristic (ROC) analysis, HbA1c failed to predict mortality with an AUC of 0.565 (95% CI: 0.307-0.782). Conclusion: The present study demonstrated that a high level of admission CBG and not HbA1c was an independent risk factor for mortality of COVID-19 patients with DM.

Uncontrolled Hyperglycemia Predicts Ventilatory Support and Duration of Hospital Stay in People with Diabetes and COVID-19

Introduction: Digital therapeutic platforms in diabetes aim to improve condition self-management and clinical outcomes. Engagement actions are well evaluated by digital monitoring or by logging iterations, and clinical outcomes by target range measurements. A new product modification in the Dario application included development of in-App educational interactions about healthy eating habits. In addition, user experience feature that help users understand the context of their blood glucose measurement was developed. This study evaluated the effect of the digital product modification. Method: A retrospective data evaluation study was performed on DarioTM members during the time before and after product modification. Digital engagement and clinical outcomes were measured on first to six months per each period to examine if habit formation was achieved. Results: A group of total 9794 users who had enrolled in a membership for 6 months or longer was evaluated. The ratio of measurements logged with context (fasting, pre-meal, post-meal, bedtime) was increased significantly by 56% in the first month following product modification on average (51.3%. vs. 32.8%) (P<0.001). Differences in the level of digital engagement remained stable over a 6 months period. The average number of days between measurements, i.e., "recency" decreased by 21% on average (2.71 vs. 3.45). Average ratios of high readings (180-400 mg/dL) were reduced by 12% on average over six months. Conclusion: The present study demonstrates that product updates to digital platforms that guide on healthy eating and help users understand their glucose readings in context may assist users in improving the management of their diabetes.