ABSTRACT
Objectives: Development of new and repurposed medicines in response to the COVID-19 pandemic has occurred at an unprecedented rate, resulting in a dynamic pipeline marked by significant challenges and successes. This analysis provides an overview of the vaccines and therapies undergoing clinical evaluation or with recent approval for the treatment and prevention of COVID-19 in global markets. Method(s): For this analysis, COVID-19 pipeline medicines are defined in three categories: vaccines, new treatments and repurposed medicines. GlobalData is the primary data source for this study, in addition to online databases from Health Canada, the US FDA, and the EMA. International markets examined include the US and geographic Europe (excluding Russia and Turkey). Result(s): As of November 2022, the global pipeline contained over 600 therapies and vaccines undergoing Phase I, II, III clinical trials or pre-registration for the prevention and treatment of COVID-19. Preventive and repurposed medicines include antivirals, immunoglobulins, monoclonal antibodies, cellular therapies, and convalescent plasma. In Canada, twelve medicines, including six vaccines, have been approved for COVID-19. The number of global approvals is greater, with approximately 9 vaccines on the market in OECD countries. In addition to pre-exposure preventative therapies, manufacturers are also developing COVID-19 drugs to be used as prophylactic therapy. The analysis identifies new oral antiviral treatments and preventative therapies in the pipeline and under review in various jurisdictions globally. Conclusion(s): This research provides a clearer picture of the characteristics and evolution of the market for new and emerging COVID-19 medicines, which will help policy-makers and other stakeholders understand and anticipate the unique pressures of the COVID-19 pandemic.Copyright © 2023
ABSTRACT
Background: Home parenteral nutrition (HPN) is the primary treatment for patients with pediatric intestinal failure. It is a complex, life-sustaining therapy requiring a central venous catheter (CVC), and carries high morbidity. Central line-associated bloodstream infection (CLABSI) is a common and potentially fatal complication of HPN. Patients on HPN require a skilled multi-disciplinary team- including physicians, nurses, dietitians and pharmacists-to prevent HPN related complications, provide safe and individualized nutrition support that is evaluated on a regular basis in the ambulatory setting. In-person visits in the clinic setting allow for HPN patients to be evaluated by all disciplines, and full assessment of weight and general condition, fluid status and laboratory values. Importantly, clinic evaluations also allow for close examination of central venous catheter (CVC), discussion with caregivers to identify potential infection risks, and opportunities for education to prevent infections and other complications. Program standard of care is bimonthly clinic and laboratory evaluation, more frequently if clinically indicated. The COVID-19 crisis required transition of many of these evaluations from in-person to telemedicine, which has created new challenges in caring for high-risk pediatric HPN patients and prevention of CLABSI. Multi-disciplinary telemedicine visits including nursing, dietitians and physicians were substituted for in-person evaluations at first exclusively at onset of pandemic, then to every other visit as COVID rates improved and vaccinations became more available. Method(s): HPN clinic encounters from 2019-present were reviewed in a large pediatric HPN program and compared to CLABSI rates. Attention was paid to in-person versus telemedicine evaluations in the setting of COVID-19 pandemic. CLABSI rate was defined as # of ambulatory infections/1000 catheter days, as defined by National Healthcare Safety Network (NHSN) guidelines. Result(s): Despite decreased frequency of in-person clinic evaluation, ambulatory CLABSI rates did not increase during this time. In fact, median CLABSI rate from 2020 to present decreased from 0.81/1000 catheter days to 0.5/1000 catheter days. In 2020, there was a mild trend toward increased CLABSI rate in patients who had higher percentage of telemedicine versus in-person encounters;however, this was not statistically significant. This trend was not observed in 2021. Conclusion(s): Pediatric patients receiving HPN are high-risk and require evaluation by a multidisciplinary team at regular intervals to maintain safety. COVID-19 pandemic interrupted ability to see these complex patients for in-person evaluation with regular frequency;therefore multidisciplinary telemedicine visits were substituted. While in-person evaluation remains the gold standard for management of patients on HPN, intermittent use of multi-disciplinary telemedicine encounters can be utilized to safely care for pediatric HPN patients, without resultant (Figure Presented).
ABSTRACT
Background: The incidence of nosocomial blood stream infections (BSI) among NICU admissions remains high, with significant mortality and morbidity. Due to COVID-19, there are increased infection prevention (IP) measures in NICUs including universal masking for all healthcare workers and families, social distancing, visitation restrictions, and increased attention to hand hygiene. These measures may also affect late-onset infection rates and offer understanding of novel interventions for prevention. Methods: We examined infection rates from three neonatal centers during the 24 months prior to implementation of COVID-19 IP measures (PRE-period) compared to the months after implementation from April 2020 (POST-period). Late-onset infections were defined as cultureconfirmed infection of the blood, urine, and other sterile fluids or identification of respiratory viral pathogens. An interrupted time series analysis of infection per 1000 patient days was performed based on a change-point Poisson regression with a lagged dependent variable and the number of patient days used as offsets. Each month was treated as independent with additional analysis using an observation-driven model to account for serial dependence. Results: Multicenter analysis to date included all infants cared for at three centers (Level 3 and 4) from 2018-2020. Monthly BSI rates decreased in the POSTperiod at the three centers (Figure 1). At all centers actual BSI rate was lower than the expected rate in the POST-period (Figure 2). The combined BSI rate per 1000 patient days was 41% lower compared to the rate prior to implementation (95% CI, 0.42 to 0.84, P = 0.004). In subgroup analysis of BSI by birthweight, during the POST-period there was a 39% reduction in infants < 1000g (P = 0.023), a 44% decrease for 1000-1500g patients (P = 0.292) and a 53% decrease in those > 1500g (0.083). Examining single center data from the University of Virginia through March 2021, there was a 36% decrease in all late-onset infections (BSI, UTI, Viral, and peritonitis) (95% CI, 0.46 to 0.90, P=0.011). Conclusion: In this preliminary analysis, we found a reduction of BSI after the implementation of COVID-19 infection prevention measures. Additionally, there were fewer viral infections, though there were a limited number of episodes. Further analyses of multicenter data and a larger number of patients from all 12 centers of our study network will elucidate the significance of these findings and the role some of these IP measures, such as universal masking, may have in infection prevention in the NICU (Supported in part by Grant Funding from the Gerber Foundation).
ABSTRACT
Background: The global COVID-19 pandemic forced the abrupt transition of in-person clinic visits to a virtual care platform in the Home Parenteral Nutrition (HPN) Program. Remote patient monitoring technology (TytocareTM) allows for accurate and validated vital sign and nutritional assessment by the caregiver which is shared asynchronously or in real-time with medical providers. This novel FDA-approved device provides high quality data, facilitates precise clinical diagnosis and requires caregiver training and participation. Without remote patient monitoring, accurate nutritional assessments during virtual visits are challenging. The implementation process of this novel device after a 6-month pilot period was investigated. Methods: Tytocare™ (TytoHome™kits, weight scales, pulse oximeters and blood pressure machines) devices (Figure 1) were provided through a Federal Communication Commission grant funding the employment of telemedicine services during the COVID-19 pandemic. 139 devices were deployed to all patients in the HPN program through mail or clinic visit/hospital distribution. 21 Tytocare™devices were returned or not accounted for due caregivers not yet reporting to have received the device (n=10), caregiver opt-out (n=4), discharge from the HPN program (n=3), repatriation (n=2), prolonged inpatient admission (n=1) and death (n=1). From November 2020 through May 2021, 97 unique Tytocare™visits were completed. Patients/caregivers were trained on how to use the TytoCare™app with their device. Patients either saw a provider online in a real-time virtual visit or submitted a TytoCare™exam asynchronously in preparation of their scheduled virtual clinic visit. Assessments included weight, pulse oximetry, heart rate, respiratory rate, blood pressure and temperature. Precise photographs of key components of the examination of a patient with intestinal failure on HPN were sent, including central venous catheter (CVC) dressings, CVC insertion sites, skin rashes and enteral tube sites. A 10-question patient experience survey was emailed to the 118 caregivers with active devices after 6 months of device deployment. Results: 85% (n=118) of patients in our HPN program reported use of the Tytocare™device during or prior to telehealth visits. Patient age ranged from 5 months to 34 years old. Of the nine responses received, results were overall favorable. The average was 7.22 for patient satisfaction (ten-level Likert scale;1 = extremely unsatisfied, 10 = extremely satisfied). 0 disagreed with the statement regarding the Tytocare™device being helpful for patient care management (five-level Likert scale;1 = strongly agree, 5 = strongly disagree) and the average for recommending the device to others was 7.56 (ten-level Likert scale;1 = extremely unlikely, 10 = extremely likely). Conclusion: With the assistance of the Innovation and Digital Health Accelerator team, the HPN program successfully and promptly implemented a remote patient monitoring program to complement our telehealth platform. The ability to utilize Tytocare™during the global COVID-19 pandemic was well-received by caregivers of patients requiring home parenteral nutrition. Of the survey responders, caregiver satisfaction and experience were favorable. However, the data presented may not be a true representation of overall impressions given the limited response rate. Future studies will investigate the feasibility, accuracy and impact of remote patient monitoring in complex pediatric populations and will focus on improving patient experience survey response rates.