ABSTRACT
Coronavirus disease (COVID-19) has become a pandemic after its outbreak in January 2020. The majority of the countries have witnessed peak effects of the disease, and they need to learn from their past experience of dealing with and pro-actively controlling the future waves. Thus, this article aims to analyse the effect of the COVID-19 pandemic on some of the key states in India and provide analytical actionable insight for better epidemic management. In this article, we have focused on Maharashtra and tried to show how other states can also incorporate pro-active pandemic management to reduce the number of causalities in the following waves. The key objectives of this article are to provide a scenario base forecasted number of patients for Maharashtra with sufficient lead time, review the current capacity of the health infrastructure, analyse the risk of the current health infrastructure, identify the breaking point of system failure in advance, measure the gap between capacity (supply) vs demand and raise alarms and device an early warning system (EWS) pro-actively. Quantitative analysis of the statistics related to COVID-19 has been done based on their official (government) data and some of the previous research work. Prophet Model has been used to forecast and then the forecasted values are combined with the daily load in hospitals to measure the extra load on the healthcare system.
ABSTRACT
Background: Admissions for acute myocardial infarction (MI) have declined significantly during the COVID-19 pandemic. The changes in the presentation, management, and outcomes of MI during the pandemic period are not well recognized, and data from low- and middle-income countries are limited.Methods: In this two-timepoint cross-sectional study involving 187 hospitals across India, patients admitted with MI between 15th March to 15th June in 2020 were compared with those admitted during the corresponding period of 2019. We sought to determine the changes in the number of admissions, management practices, and outcomes.Findings: We included 41,832 consecutive adults with MI. Admissions during the pandemic period (n = 16414) decreased by 35·4% as compared to the corresponding period in 2019 (n = 25418). We observed significant heterogeneity in this decline across India with the North zone reporting greater decline (-44·8%) than the South zone (-27·7%). The weekly average decrease in MI admissions in 2020 which peaked around the mid- study period, correlated negatively with the number of COVID cases (r = -0·48; r 2 = 0·2), but strongly correlated with the stringency of lockdown index (r = 0·95; r 2 = 0·90). On a multi-level logistic regression, admissions were lower in 2020 with older age categories, tier 1 cities, and centers with high patient volume, and teaching programs. Adjusted utilization rate of coronary angiography, and percutaneous coronary intervention decreased by 11·3%, and 5·9% respectively. However, the in-hospital mortality rates did not differ.Interpretation: The magnitude of reduction in MI admissions across India was not uniform. The nature, time course, and the patient demographics were different compared to reports from other countries, suggesting a significant impact due to the lockdown. These findings have important implications in managing MI admissions during the pandemic.Funding Statement: The study is funded by cardiological society of India.Declaration of Interests: Nothing to declare for all the authors.Ethics Approval Statement: Individual participating centres either obtained an ethical approval from respective Institutional ethics committees or a no objection certificate from the administration.
Subject(s)
COVID-19 , Coronary AneurysmABSTRACT
In the current scenario, developing treatments, identifying cures and formulating intervention strategies to fight against the COVID-19 outbreak, have become the major concern for researchers globally. Several studies have confirmed the molecular pathway of COVID-19 virulence that involves activation of proteins like angiotensin-converting enzyme 2 (ACE2), angiotensin (AT) receptor which is mainly AT1, and transmembrane protease serine 2 (TMPRSS2). Since the virus needs the involvement of these proteins, over and above its spike protein, for activation and infecting the host, it is obvious that targeting or blocking the activation of these molecules may play a critical role in the development of therapeutics for the cure and management of COVID-19. Many studies have been reported and several are ongoing to find a cure using these molecules as a target. While initially COVID-19 was thought to be affecting the human respiratory system, recent shreds of evidence indicate that this infection can reach beyond the lungs. It can invade and rampage almost all the organs in the body, and 'cytokine storm' is considered to be responsible for this. The reason for disease severity is not what matters anymore now, everyone is hoping for a cure soon enough. Therefore, there is an urgent need to search for some novel drugs/chemicals. Towards this end, natural products can contribute immensely since they have a long history of usage for the cure and management of various ailments, including viral infections. Various natural products (mainly from plants) have structural similarities to the molecules which by AT has been shown to interact with targets used by COVID-19 during its infection. This is indeed a positive indication for the development of natural products-based therapeutics. This aspect, therefore, warrants serious consideration for the cure and management of the COVID-19 pandemic.
ABSTRACT
Objectives: We aimed to review the evidence for a living systematic benefit risk assessment for convalescent plasma use amongst patients with severe COVID-19 disease, based on currently available data. Methods: The assessment used the Benefit-Risk Action Team (BRAT) framework. Convalescent plasma treatment in severe COVID-19 was compared to standard of care, placebo or other treatments. A literature search was conducted to identify published papers from January 1st, 2019 until July 8th, 2020. A value tree was constructed which included ranked key benefits and risks. Results: We screened 396 papers from PubMed and 127 papers from Embase. Four studies were eligible for inclusion as they contained comparative data. Results from a randomised controlled trial revealed a non-statistically significant shortening of time to clinical improvement of 2.15 days (95% CI, -5.28 to 0.99 days) in the intervention group compared with the control group, with a possible signal of increased efficacy amongst a small subset of patients with severe disease (but not life threatening disease), however this study may have been underpowered. Interpretation of findings amongst the three controlled non-randomised studies were limited by small patient numbers, lack of randomisation, and confounding by co-administration of other treatments. Limited data availability at the current time precluded construction of a data summary table and further quantitative analysis. Conclusions: There was insufficient evidence from controlled studies to complete a data summary table for a systematic benefit-risk assessment of the use of CP for severe COVID-19 disease at the current time, and as such a benefit-risk conclusion could not be made. Whilst uncontrolled case series have suggested positive findings with CP, results from these studies are very difficult to interpret. We provide a framework which can be updated when further data that have an impact on the benefit-risk become available.
Subject(s)
COVID-19ABSTRACT
Background: COVID-19 is an ongoing, global public health crisis for which safe and effective treatments need to be identified. The benefit-risk balance for use of lopinavir-ritonavir in COVID-19 needs to be monitored on an ongoing basis, therefore a systematic benefit-risk assessment was designed and conducted. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation; although initially this evaluation is likely to contain limited information, it is required due to the urgent unmet public need. Importantly it allows additional data to be incorporated as it becomes available, and re-evaluation of the benefit-risk profile. Methods: A systematic benefit-risk assessment was conducted using the Benefit-Risk Action team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in COVID-19 compared to standard of care, placebo or other treatments. A literature search was conducted in PubMed and EmBase to identify peer-reviewed papers reporting clinical outcomes. Two clinicians constructed a value tree and ranked key benefits and risks in order of considered clinical importance. Results: In comparison to standard of care, data for several key benefits and risks were identified for lopinavir-ritonavir. Time to clinical improvement was not significantly different for lopinavir-ritonavir in comparison to standard of care (HR=1.31, 95% CI:0.95, 1.80). There appeared to be fewer serious adverse events with lopinavir-ritonavir (20%) vs standard of care (32%). In particular, there were fewer cases of acute respiratory distress syndrome with lopinavir-ritonavir compared to standard of care (13% vs 27%). Limited data were available for comparison of lopinavir-ritonavir to other treatments. Conclusions: Based on currently available data, there was no clear benefit for use of lopinavir-ritonavir compared to standard of care in severe COVID-19. Risk data suggested a possible decrease in serious adverse events, including acute respiratory distress syndrome. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available.
Subject(s)
COVID-19 , Respiratory Distress SyndromeABSTRACT
Objectives: Given the current pandemic, there is an urgent need to identify effective, safe treatments for COVID-19 (coronavirus disease). A systematic benefit-risk assessment was designed and conducted to strengthen the ongoing monitoring of the benefit-risk balance for chloroquine (CQ) and hydroxychloroquine (HCQ) in COVID-19 treatment. Methods: The overall benefit-risk of the use of chloroquine or hydroxychloroquine as a treatment for COVID-19 compared to standard of care, placebo or other treatments was assessed using the Benefit-Risk Action Team (BRAT) framework. We searched PubMed and Google Scholar to identify literature reporting clinical outcomes in patients taking chloroquine or hydroxychloroquine for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. Results: Several potential key benefits and risks were identified for use of hydroxychloroquine or chloroquine in COVID-19 treatment. Currently available results did not show an improvement in mortality risk; Cox proportional hazard ratio (HR) for death between patients who received HCQ alone vs. neither hydroxychloroquine or azithromycin was 1.08 (95% CI 0.63-1.85). A further study compared the incidence of intubation or death (composite outcome) in a time to event analysis between patients who received HCQ vs. those patients who did not (adjusted Cox proportional HR 1.00 (95% CI 0.76-1.32)). Risk of cardiac arrest, abnormal electrocardiogram (ECG) and QT prolongation was greater among patients taking HCQ (with or without azithromycin) compared to standard of care in the same study. Conclusions: Overall, based on the available data there does not appear to be a favourable benefit-risk profile for chloroquine or hydroxychloroquine compared to standard of care in treatment of severe COVID-19. As further data from clinical trials and real world use on these benefits and risks becomes available, this can be incorporated into the framework for an ongoing benefit-risk assessment.
Subject(s)
Coronavirus Infections , Long QT Syndrome , Heart Arrest , Death , COVID-19ABSTRACT
Background: There is a need to identify effective, safe treatments for COVID-19 (coronavirus disease) rapidly, given the current, ongoing pandemic. A systematic benefit-risk assessment was designed and conducted to strengthen the ongoing understanding of the benefit-risk balance for remdesivir in COVID-19 treatment by using a structured method which uses all available data. Methods: The Benefit-Risk Action Team (BRAT) framework was used to assess the overall benefit-risk of the use of remdesivir as a treatment for COVID-19 compared to standard of care, placebo or other treatments. We searched PubMed,Google Scholar and government agency websites to identify literature reporting clinical outcomes in patients taking remdesivir for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. Results: Several key benefits and risks for use of remdesivir in COVID-19 compared to placebo have been identified. In one trial, the benefit of time to clinical improvement was not statistically significant (21 vs 23 days, HR=1.23, 95% CI: 0.87, 1.75), although the study was underpowered. In another trial, a shorter time to recovery in patients treated with remdesivir was observed (11 vs 15 days), with non-significant reduced mortality risk (8% vs 12%). Risk data were only available from one trial. This trial reported fewer serious adverse events in patients taking remdesivir (18%) comparted to the placebo group (26%), however more patients in the remdesivir group discontinued treatment as a result of an adverse event compared to those patients receiving placebo (12% vs 5%). Conclusions: Preliminary clinical trial results suggest a favourable benefit-risk profile for remdesivir compared to placebo, however there is limited safety data available at the current time. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit-risk assessment.