Background Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country. Methods COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one post-baseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369). Findings 180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference −3·71 [95% CI −18·23 to 11·19]; p=0·42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during t...
Two MDR Salmonella Typhi isolates from India were found by whole genome sequencing to be closely related to the 2016 XDR S. Typhi outbreak strain from Pakistan. The Indian isolates have no chromosomal antimicrobial resistance cassette but carry the IncY plasmid p60006. Both isolates are susceptible to chloramphenicol, azithromycin, and carbapenems.
After declaration of Covid – 19 as pandemic by WHO, countries adopted several measures to contain the spread as well as test and treat the patients. Further, as no effective management protocols to address this pandemic were available, a need was felt to explore the integration of modern and traditional medicines to treat Covid 19 cases. In view of this an exploratory nonrandomized prospective study has been undertaken for comparing the outcomes of traditional Ayurvedic classical formulation of Tinospora cordifolia ( Guduchi ) and Piper longum ( Pippali ) as an add on to standard of care (SOC) using modern medicine with SOC alone. This has been done in mild and moderate Covid – 19 cases, at a tertiary care integrative Medicine hospital in the National Capital Region, Gurgaon, India. The outcomes have been evaluated in terms of the duration of hospital stay, the time to clinical recovery, safety and non-interference/interaction of Ayurvedic and Further, long term impact of Covid – 19 treatment has been evaluated using quality of life questionnaire after 3 months of discharge. Findings of present study reveals that the Ayurveda add-on formulation of Tinospora cordifolia ( Guduchi ) and Piper longum (Pippali ) has reduced the length of hospital stay and improve the recovery time. General feeling of wellbeing and activity levels were better in the 3 month follow-up post discharge in the Ayurveda add-on group. It is suggested that this formulation needs further investigated to provide more information on effective and safe herbal add-on to SOC for better outcomes to treatment of COVID-19 disease.
Background Increased occurrence of mucormycosis during the second wave of COVID-19 pandemic in early 2021 in India prompted us to undertake a multi-site case–control investigation. The objectives were to examine the monthly trend of COVID-19 Associated Mucormycosis (CAM) cases among in-patients and to identify factors associated with development of CAM. Methods Eleven study sites were involved across India; archived records since 1st January 2021 till 30th September 2021 were used for trend analysis. The cases and controls were enrolled during 15th June 2021 to 30th September 2021. Data were collected using a semi-structured questionnaire. Among 1211 enrolled participants, 336 were CAM cases and 875 were COVID-19 positive non-mucormycosis controls. Results CAM-case admissions reached their peak in May 2021 like a satellite epidemic after a month of in-patient admission peak recorded due to COVID-19. The odds of developing CAM increased with the history of working in a dusty environment (adjusted odds ratio; aOR 3.24, 95% CI 1.34, 7.82), diabetes mellitus (aOR: 31.83, 95% CI 13.96, 72.63), longer duration of hospital stay (aOR: 1.06, 95% CI 1.02, 1.11) and use of methylprednisolone (aOR: 2.71, 95% CI 1.37, 5.37) following adjustment for age, gender, occupation, education, type of houses used for living, requirement of ventilatory support and route of steroid administration. Higher proportion of CAM cases required supplemental oxygen compared to the controls; use of non-rebreather mask (NRBM) was associated as a protective factor against mucormycosis compared to face masks (aOR: 0.18, 95% CI 0.08, 0.41). Genomic sequencing of archived respiratory samples revealed similar occurrences of Delta and Delta derivates of SARS-CoV-2 infection in both cases and controls. Conclusions Appropriate management of hyperglycemia, judicious use of steroids and use of NRBM during oxygen supplementation among COVID-19 patients have the potential to reduce the risk of occurrence of mucormycosis. Avoiding exposure to dusty environment would add to such prevention efforts.
Introduction: COVID-19 usually presents with upper respiratory tract infection in varying severity which can lead to sepsis. Early prediction of sepsis may reduce mortality by timely interventions. The intended purpose of this study was to determine whether the advanced parameters like the extended inflammation parameters (EIPs) can predict prognosis and early progression to sepsis as a sequel of COVID-19 infection and can be used as a screening profile. Also, to evaluate the Intensive Care Infection Score (ICIS) and the COVID-19 prognostic score and validate the scores for our population. Methods: Prospective observational study of 50 reverse transcription-polymerase chain reaction (RT-PCR) proven admitted COVID-19 patients. The data assessed included complete blood counts (CBC) with EIP measurements, from Day 1 of admission to Day 10. The following groups were studied: noncritical (NC) and critical illness (CI) in COVID-19 positive cases, COVID negative sepsis and nonsepsis cases, and healthy volunteers for reference range. Results: The parameters that showed statistically significant higher mean in CI group compared to the NC group are reactive lymphocyte number and percentage (RE-LYMPH#, RE-LYMPH%), antibody synthesizing lymphocyte number and percentage (AS-LYMPH#, AS-LYMPH%), Reactive monocyte count and percentage (RE-MONO#, RE-MONO%/M), ICIS, COVID-19 prognostic score (p-value <0.05). The AUC confirmed the diagnostic accuracy of all these parameters. From the multivariate logistic regression, the significant risk factor was RE-LYMPH# with cut-off >0.10 (p value: 0.011). Conclusion: The new EIP parameters, RE-MONO#, RE-MONO%/M, ICIS score and COVID-19 prognostic score are useful for early prediction of critical illness. AS-LYMPH is the most useful predictor of critical illness on multivariate analysis. RE-MONO# and RE-MONO%/M parameter are useful in distinguishing critical and noncritical non-COVID and COVID-19 patients.
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