Real-World Evidence-Current Developments and Perspectives.

Real-world evidence (RWE) is increasingly involved in the early benefit assessment of medicinal drugs. It is expected that RWE will help to speed up approval processes comparable to RWE developments in vaccine research during the COVID-19 pandemic. Definitions of RWE are diverse, marking the highly fluid status in this field. So far, RWE comprises information produced from data routinely collected on patient's health status and/or delivery of health care from various sources other than traditional clinical trials. These sources can include electronic health records, claims, patient-generated data including in home-use settings, data from mobile devices, as well as patient, product, and disease registries. The aim of the present update was to review current RWE developments and guidelines, mainly in the U.S. and Europe over the last decade. RWE has already been included in various approval procedures of regulatory authorities, reflecting its actual acceptance and growing importance in evaluating and accelerating new therapies. However, since RWE research is still in a transition process, and since a number of gaps in this field have been explored, more guidance and a consented definition are necessary to increase the implementation of real-world data.

Seven COVID-19 Patients Treated with C-Reactive Protein (CRP) Apheresis.

BACKGROUND: The fulminant course of COVID-19, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), presents with a high mortality rate and still lacks a causative treatment. C-reactive protein (CRP) has been shown to increase dramatically during the disease progression and correlates with deleterious outcomes. Selective CRP apheresis can reduce circulating CRP levels fast and effective. METHODS: Seven hospitalized patients with documented severe COVID-19 progression, elevated CRP plasma levels (>100 mg/L) and signs of respiratory failure were treated with CRP apheresis. Two to twelve CRP apheresis sessions were performed generally in 24 h time intervals and depending on CRP plasma levels. RESULTS: All patients had comorbidities. CRP apheresis reduced CRP plasma levels by up to 84% within a few hours, without exhibiting side effects in any patient. Despite signs of severe lung infiltration in all patients, only one patient died. The other patients showed improvements within the chest X-ray after CRP apheresis and were able to recover regardless of intubation and/or ECMO (4 patients). All remaining six patients were discharged from the hospital in good clinical condition. CONCLUSIONS: This case series presents a mortality rate of only 14%, which is dramatically lower than expected from the presented CRP levels as well as comorbidities and ventilation requirements. Our clinical observations regarding the here presented seven patients support the hypothesis that CRP is a candidate to be therapeutically targeted in the early stage of severe COVID-19.

School Teachers' Self-Reported Fear and Risk Perception during the COVID-19 Pandemic-A Nationwide Survey in Germany.

With the coronavirus disease 2019 (COVID-19) cases peaking and health systems reaching their limits in winter 2020/21, schools remained closed in many countries. To better understand teachers' risk perception, we conducted a survey in Germany. Participants were recruited through various associations and invited to take part in a cross-sectional COVID-19-specific online survey. Descriptive statistical analysis was performed. Factors associated with teachers' fears of contracting the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) were evaluated with an adjusted multivariable regression analysis. The median age of the 6753 participating teachers was 43 years, and 77% were female. Most teachers worked in high schools (29%) and elementary schools (26%). The majority of participants (73%) feared contracting SARS-CoV-2 at school, while 77% intended to receive their COVID-19 vaccination. Ninety-eight percent considered students to pose the greatest risk. Female and younger teachers were significantly more anxious to get infected and teachers who opposed the re-opening of schools had significantly higher odds of being more anxious (p < 0.001). To the authors' knowledge, this is the first study to describe teachers' risk perception of COVID-19 and their attitudes towards vaccinations in a nationwide survey. The anxiety correlates with the COVID-19 protection measures demanded and appears to be a driving factor rather than rational logic.