A Randomized Trial of Ivermectin 600 Mcg/Kg Vs Placebo in Mild/ Moderate Covid-19

Background: Whether ivermectin, with a maximum targeted dose of 600 mug/ kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains unknown. Our objective was to evaluate the effectiveness of ivermectin, maximum targeted dose of 600 mug/kg, daily for 6 days compared with placebo for the treatment of early mild to moderate COVID-19. Method(s): ACTIV-6, an ongoing, decentralized, randomized, double-blind, placebo-controlled, platform trial, was designed to evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A total of 1206 participants age >=30 years with confirmed COVID-19, experiencing >=2 symptoms of acute infection for <=7 days, were enrolled from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022, at 93 sites in the US. Participants were randomized to receive ivermectin, with a maximum targeted dose of 600 mug/kg (n=602), daily vs placebo daily (n=604) for 6 days. The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28. Result(s): Among 1206 randomized participants who received study medication or placebo, median (interquartile range) age was 48 (38-58) years;713 (59%) were women;and 1008 (84%) reported >=2 SARS-CoV-2 vaccine doses. Median time to recovery was 11 (11-12) days in the ivermectin group and 11 (11-12) days in the placebo group. The hazard ratio (HR) (95% credible interval [CrI], posterior probability of benefit) for improvement in time to recovery was 1.02 (0.92-1.13;P[HR >1]=0.68). In those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (HR 1.0, 0.6-1.5;P[HR< 1]=0.53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%);2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups. Conclusion(s): Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 mug/kg daily for 6 days, compared with placebo did not improve time to recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19. Primary and secondary outcomes.

Administration of the TNF-alpha inhibitor, infliximab, reduces mortality in hospitalized patients with COVID pneumonia. Results of a randomized controlled trial

Background. Severe COVID-19 infection is characterized by a dysregulated hyperinflammatory state that contributes to morbidity and mortality. Immunomodulatory therapy has been shown to improve outcomes. We investigated if the TNF-alpha inhibitor, infliximab (IFX), provides additional benefit over standard of care. Methods. We conducted a double-blind, randomized, placebo-controlled trial of IFX (single infusion of 5 mg/kg) compared to standard of care (including remdesivir and dexamethasone) in patients hospitalized with COVID-19 pneumonia. The primary outcome was time to recovery by day 29. Key secondary endpoints included 14-day clinical status and 28-day mortality. Results. A total of 1033 patients received study agent (517 assigned to IFX, 516 to common placebo), constituting the analyzed modified intention-to-treat cohort. Mean age 54.8 years, 60.3% were male, 48.6% Hispanic/Latino and 14% Black. Randomization was balanced for severity of illness and comorbidities. Participants randomized to IFX did not show a statistically significant difference in the primary endpoint with a recovery rate ratio of 1.13 (95% CI 0.99-1.27, p=0.0631) compared to placebo. The median (IQR) time to recovery was 8 days (7, 9) for IFX and 9 days (8, 10) for placebo. Patients assigned to IFX were more likely to have an improved clinical status at day 14 (OR 1.32;95% CI 1.05, 1.66). The 28-day mortality was 10.1% in the IFX arm and 14.5% in the placebo (OR 0.59 (95% CI 0.39, 0.90)), with a 40.7% lower odds of dying in patients receiving IFX. The improvement in mortality was demonstrated in patients requiring low- or high-flow O2 at baseline but not in those requiring mechanical ventilation or ECMO. Subgroup analysis identified the strongest effect in those with baseline CRP >75mg/ml. There was no imbalances in serious adverse events. Secondary infections were similar between groups (IFX 18.0%, placebo 16.5%). Conclusion. Although single-dose IV IFX did not demonstrate statistically significant improvement in time to recovery, it was associated with improvement in clinical status at day 14 and showed a substantial reduction in 28 day mortality compared to standard of care.

Fluvoxamine for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial

Background. The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild-to-moderate coronavirus 2019 (COVID-19) is unclear. Tolerability has also been identified as a potential limiting factor for 100 mg twice daily of fluvoxamine. We evaluated the efficacy of low-dose fluvoxamine 50 mg twice daily for 10 days compared with placebo for the treatment of early mild-to-moderate COVID-19. Methods. ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial testing repurposed medications in outpatients with confirmed SARS-CoV-2 infection. Non-hospitalized adults aged >= 30 years, experiencing >= 2 symptoms of acute infection for <= 7 days were randomized to fluvoxamine 50 mg twice daily for 10 days or placebo. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Secondary outcomes included composites of hospitalization or death with or without urgent care or emergency department visit by day 28. Results. Of those eligible for the fluvoxamine arm, 675 were randomized to and received fluvoxamine;619 received concurrent placebo. Sixty-six percent of the study population reported at least 2 doses of a COVID-19 vaccine. There was no evidence of improvement in time to recovery with fluvoxamine compared with placebo (hazard ratio [HR] 0.96, 95% credible interval [CrI] 0.86-1.06;posterior probability for benefit [HR > 1]=0.2). Sixteen participants (2.4%) in the fluvoxamine arm had urgent care or emergency department visits or were hospitalized compared with 11 (1.8%) in the pooled, concurrent placebo arm (HR 1.5, 95% CrI 0.5-3.0;posterior probability for benefit [HR < 1]=0.1725). No participant in either arm was hospitalized, and no deaths occurred. Adverse events were uncommon in both arms. Conclusion. Treatment with low-dose fluvoxamine 50 mg dosed twice daily for 10 days did not result in improved time to recovery among outpatients with COVID-19 in the United States during the delta and omicron variant surges.

Results from ACTIV-6: A Decentralized, Double-Blinded, Randomized, Placebo-Controlled Platform Trial of Repurposed Drugs for the Treatment of Mild-to-Moderate COVID-19

Background. The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild-to-moderate coronavirus 2019 (COVID-19) is unclear. Tolerability has also been identified as a potential limiting factor for 100 mg twice daily of fluvoxamine. We evaluated the efficacy of low-dose fluvoxamine 50 mg twice daily for 10 days compared with placebo for the treatment of early mild-to-moderate COVID-19. Methods. ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial testing repurposed medications in outpatients with confirmed SARS-CoV-2 infection. Non-hospitalized adults aged >= 30 years, experiencing >= 2 symptoms of acute infection for <= 7 days were randomized to fluvoxamine 50 mg twice daily for 10 days or placebo. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Secondary outcomes included composites of hospitalization or death with or without urgent care or emergency department visit by day 28. Results. Of those eligible for the fluvoxamine arm, 675 were randomized to and received fluvoxamine;619 received concurrent placebo. Sixty-six percent of the study population reported at least 2 doses of a COVID-19 vaccine. There was no evidence of improvement in time to recovery with fluvoxamine compared with placebo (hazard ratio [HR] 0.96, 95% credible interval [CrI] 0.86-1.06;posterior probability for benefit [HR > 1]=0.2). Sixteen participants (2.4%) in the fluvoxamine armhad urgent care or emergency department visits or were hospitalized compared with 11 (1.8%) in the pooled, concurrent placebo arm (HR 1.5, 95% CrI 0.5-3.0;posterior probability for benefit [HR < 1]=0.1725). No participant in either arm was hospitalized, and no deaths occurred. Adverse events were uncommon in both arms. Conclusion. Treatment with low-dose fluvoxamine 50 mg dosed twice daily for 10 days did not result in improved time to recovery among outpatients with COVID-19 in the United States during the delta and omicron variant surges.

'Of what is past, or passing, or to come1': corpus linguistics, changes and challenges

This chapter introduces the second edition of the Routledge Handbook of obviated bythe capacity to store vastCorpus Linguistics. It reflects on advances in the field since 2010. The chapter notes that the decade has seen major changes in the availability of corpora, with cloud-based storage making available multi-billion-word corpora. The rise in rapid-response corpora is noted. These can be assembled to respond to pressing political and social issues (e.g. Brexit and COVID-19). Such corpora allow researchers to track societal thought processes around these major societal events. The chapter also flags the changes in text types, with the proliferation of social media content. The authors query whether corpus tools areready for such multi-modalities. Learner corpora are also highlighted as being in a phase ofchange with a “profiling turn” emerging. This is linked to a greater synergy between corpus linguistics and second language acquisition. The chapter ends with a look back to the ancient monastic origins of concordancing and notes that now our software can replicate the work of 500 monks in nanoseconds. The chapter ends with a caveat: amid the richness of ever-growing data and ever-advancing tools, there are a risk and a responsibility to safeguard the tenets of principled sampling, corpus design and representativeness. © 2022 selection and editorial matter, Anne O’Keeffe and Michael J. McCarthy;individual chapters, the contributors.

Optimizing the use of Paxlovid in clinical practice.

On December 22, 2021, the United States Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for nirmatrelvir/ritonavir (Paxlovid) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19). The drug is authorized for use in patients 12 years of age and older weighing at least 40 kg who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and who are at high risk for progression to severe COVID-19. Nirmatrelvir, an orally bioavailable protease inhibitor that prevents SARS-CoV-2 replication by cleaving the two viral polyproteins, is packaged with ritonavir, a cytochrome P450 (CYP)3A4 inhibitor and pharmacokinetic boosting agent that increases nirmatrelvir concentrations. Although Paxlovid has demonstrated clinical efficacy in unvaccinated patients with COVID-19, its role in the treatment of other populations is less clear. This manuscript reviews what is known about Paxlovid and explores how this drug may be used in the future to treat patients with SARS-CoV-2 infection.

Who’s talking about cystic fibrosis continued: the effects of the COVID-19 pandemic on the cystic fibrosis online landscape

Background: Due to COVID-19, we saw an increased usage of digital platforms for healthcare delivery. However, its effect on internet postings for CF during 2021 is unknown. Methods: CF key phrases were identified by a CF MDT and entered in Google Alerts and tracked for 6 months in 2021. Alertswere also created for Asthma, COPD and Lung Fibrosis. Data recorded for each alert includes the date, title, URL, category, country of origin;if a discussion, like/share took place. Thiswas then compared against previous data collected (2015, 2019). Results: The number of CF alerts recorded decreased (2021:1846– 2015:2742) while the number of blocked alerts increased (2021:325– 2015:89). Almost half of the CF alerts originated from the USA. In 2021, News was the most common category (33.96%) followed by Financial/ Marketing (25.73%) and Medical (21.07%). The most common category for 2015 was News (58.35%) and Financial/Marketing in 2019 (35.2%). The majority of CF terms experienced an increase in quantity, specifically alerts relating to CF pathogens or changing condition expectations, such as Pseudomonas (2021:718, 2015:149), CFLD(2021:428, 2019:865, 2015:37), and CF Pregnancy (2021:91, 2015:5). For the comparative lung conditions, in 2015 Asthma was the most common alert (985) followed by CF, COPD, and Lung Fibrosis. In 2019 CF (605) was the most common. In 2021, the quantity of alerts decreased for all conditions, with CF (316) and Asthma (336) being of similar magnitude. Conclusion: The landscape for CF internet postings continues to evolve. CF is discussed frequently online, with the focus of these discussions changing to news items in 2021. The increased frequency of specific CF terms may reflect changing expectations (e.g Pregnancy). The number of blocked alerts continues to increase, potentially reflecting different global GDPR practices. Online non-EU healthcare resources need to factor this into their practice to avoid potential correct information loss for EU patients.

The role of bounded-authority concerns in shaping citizens' duty to obey authorities during COVID-19

Purpose The COVID-19 pandemic has necessitated the introduction of extra-ordinary restrictions to mitigate its spread. Authorities rely on the public's voluntary willingness to obey these restrictions, yet the intrusive nature of these measures may lead some people to believe that authorities are overstepping the limits of their rightful power (i.e. bounded-authority). This paper applies the bounded-authority framework to the COVID-19 context to understand the factors associated with the public's duty to obey authorities during COVID-19. Design/methodology/approach This paper utilizes survey data from 1,582 individuals to examine what factors drive COVID-19-related bounded-authority concerns, and in turn, how bounded-authority concerns may impact one's duty to obey authorities during COVID-19. Findings Results show that worry about freedom loss, opposition to surveillance tactics, police heavy-handedness and perceptions of procedural injustice from police during the pandemic all drive bounded-authority concerns. Findings also reveal that bounded-authority concerns are associated with reduced duty to obey and mediate the relationship between procedural justice and the duty to obey authorities' enforcement of COVID-19 restrictions. Originality/value Findings reveal new evidence about the bounded-authority framework and the public's duty to obey authorities, with implications for the COVID-19 context and beyond.

Training Future Research Psychiatrists: Experience From the First Eight Match Classes of an NIMH-Funded Psychiatry Research Residency Track

Background: In 2014, UCSD initiated an NIMH-funded Research Residency Track (RRT) to increase the number and diversity of physician-scientists pursuing careers in Psychiatry research. This RRT’s novel curriculum prepares Residents for a successful academic career and its Summer Research Fellowship (URMSRF) connects under-represented minority (URM) MS1 medical students with Psychiatry research at a critical phase in career/identity development. This report describes results after 8 “Match” cycles, 4 graduating classes of Research Track Residents and 7 Summer URMSRF cycles. Methods: Outcome metrics for all trainees – Residents and URMSRF students – were used to assess program effectiveness. Results: 14 Residents have “matched” into this RRT (12 MD/PhD;2 MD;M:F=7:7): 7 have graduated, and 7 remain as PGY1-4. Two other MD/PhD Residents (M:F=1:1) joined “internally” as PGY2-3’s. Retention is 100%. Residents averaged >2 s and >2 peer-reviewed publications as lead- or co-author and >4 national honors/travel awards/competitive grants. Of the 7 graduates who “matched” into this RRT, 100% hold academic positions: 1 is a PGY5 Fellow and 6 have academic faculty appointments with stable research funding, 5 with NIH K- or VA Career Development Awards. Of 14 URMSRF students, 9 have graduated from medical school, 6 of whom pursued Psychiatry Residencies (2 in Psychiatry RRT’s) and 1 is a PGY5 Research Fellow. Conclusions: This RRT accomplishes NIMH goals of increasing the pipeline of diverse Psychiatric researchers. Comparison groups and program details will be discussed, as will five challenges: 1. Funding;2. URM recruitment;3. COVID-19;4. Maternity/paternity leave;5. success of “Internal” vs. “Matched” Residents. Supported By: MH101072 Keywords: Training, Education, Residency

p A time of transition: changes in Irish food behaviour and potential implications due to the COVID-19 pandemic

Consumers' food choice decisions are generally relatively stable over time;consumers engage in habitual decision-making due to the high frequency of such decisions for efficiency reasons. As a result, habits are strong predictors of eating behaviour. However, changes in the life of the individual or the external environment can result in more conscious consideration of food choice motives and a transition to new patterns of behaviour to fit the new context. The coronavirus disease 2019 (COVID-19) pandemic is examined in this paper as a particularly useful case of how a change in context affects food choice trajectories. Drawing on results from an online survey of 651 food consumers in Ireland, it examines food planning, shopping, preparation and eating behaviour, including stockpiling and influences on decision-making. Overall, it finds significant evidence of a transition towards new patterns of behaviours, with two distinct clusters identified - the "Covid copers" and the "restless restrictors". For both groups, the shopping experience has become stressful resulting in reduced frequency of shopping and higher levels of planning. Conversely, time pressures related to cooking have reduced, with enjoyment associated with such activities. This is also reflected in stockpiling behaviour;the top three foods most likely to have been stockpiled in Ireland were pasta/rice, eggs and flour, reflecting the nation's desire to bake and cook during the pandemic. These behaviours are discussed in the context of emerging supply chain actor responses, with considerations for future strategic decisions identified, along with some opportunities for public health nutrition interventions.

Repurposing approach of fluvoxamine for COVID-19

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that was approved by the U.S. Food and Drug Administration (FDA) in 1994 for the treatment of obsessive-compulsive disorder and is now used to treat a variety of psychiatric conditions, including social anxiety disorder and depression. In addition to its neurocognitive effects, fluvoxamine has been noted to have anti-inflammatory properties, suggesting it may have a role in the treatment of diseases beyond the realm of the central nervous system. Although fluvoxamine is not FDA-approved for the treatment of any infection, there is emerging evidence that the drug may improve clinical outcomes in patients with COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This paper reviews the pleiotropic properties of fluvoxamine and looks ahead, to explore how the drug may be used to treat the inflammatory sequelae of COVID-19 in the future.

Nurse and nurse practitioner-lead monoclonal antibody initiative for solid organ transplant (SOT) recipients with COVID-19

Purpose: Monoclonal antibody (mAB) infusion (bamlanivimab or casirivimab/ imdevimab) for symptomatic, non-hypoxemic, high-risk outpatients with COVID-19 infection, is an available early intervention for COVID-19+ SOT recipients. We aimed to assess efficiency in time from diagnosis to treatment, and outcomes in a retrospective cohort of SOT recipients with COVID-19 who received mAB. Methods: We developed a Nurse Coordinator-led initiative to screen, refer, and facilitate mAB infusion for COVID-19+ SOT recipients within 10 days of symptom onset. SOT recipients received electronic messaging to promptly report potential COVID-19 symptoms to the transplant team. Data were collected on time from symptom onset to diagnosis, mAB infusion, and follow-up > 21 days, and hospital admissions, disease severity, mortality, and rejection. Results: 34 out of 36 referred SOT recipients with symptomatic COVID-19 disease without hypoxia received mAB therapy (3 heart, 8 lung, 16 kidney, 2 Liver-Kidney, 2 Pancreas-Kidney, 3 Kidney-Heart). Median time from symptom onset to diagnosis was 2 days and from date of diagnosis to mAB infusion was 4 days. Of those 34, 88% did not require hospitalization and recovered uneventfully. 12% required hospitalization for COVID disease progression, two on the same day as mAB infusion, and the other 2, more than 26 days post infusion. Of these, 2 patients had mild-moderate hypoxia, and 2 had critical disease. Only 1 patient died from COVID-19 complications and no episodes of rejection or graft loss were observed. Conclusions: The Nurse Coordinator-led initiative efficiently facilitated mAB therapy for COVID-19+ SOT recipients and was associated with excellent outcomes. Compared to prior published COVID-19 outcomes in SOT recipients, patients who received mAB may have reduce hospitalization and low mortality. As mAB therapy may be underutilized in the general population, these results support efforts to educate transplant centers to implement efficient interventions for the screening and referral of COVID+ SOT recipients for mAB therapy.

Acceptance of COVID-19 vaccination among cancer patients in an Irish cancer centre

Background: Hospitalised cancer patients have a three times higher risk of death (14%) from COVID-19 than the general public. Vaccination provides an unprecedented opportunity to decrease morbidity & mortality, however, there is a limited data regarding cancer patients’ attitudes towards COVID-19 vaccination. Methods: An anonymised questionnaire was completed by volunteering cancer patients attending the ambulatory care unit of a large tertiary cancer centre (Feb to April 2021), prior to vaccination rollout in this cohort. It assessed patients’ acceptance of, and attitudes toward, COVID-19 vaccination. Statistical significance was assessed with Chi-square test (χ2). Results: There was an 80% response rate (143/179). This included 79 females (55%) with a median age range of 51–60 yrs. (n = 35/24%). Most (78%) had a good performance status (PS = 0-1) & lung was the most frequent (28%) cancer type. Eight (6%) had previous COVID-19 infection. Among respondents, 128 (90%) intended on getting vaccinated, 12 (8%) were unsure & three (2%) would refuse. Those intent on vaccination were less concerned with side effects, viewed the pandemic as serious & perceived cancer as a cause for more severe infection compared to the rest (Table). All 101 (71%) patients who received the influenza vaccine were intent on COVID vaccination. Almost 20% (n=28) reported that they were more likely to receive the flu vaccine due to the pandemic. Twelve (8%) identified attending their GP as a barrier, with 97% (n=135) willing to attend hospital for vaccination. While this service is free, 69% (n=99) were willing to pay, with nearly 40% (n=57) up to €50. [Formula presented] Conclusions: Our study demonstrates a very high acceptance rate of COVID-19 vaccination among Irish cancer patients such that many would be willing to pay & attend hospital to receive it. The barriers to uptake provide an opportunity to improve education. An unexpected consequence, may be a beneficial increased uptake of the influenza vaccine. Legal entity responsible for the study: S. Cuffe. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

TeCC (TeleMedicine, Cystic Fibrosis, Corona-Virus) study in a previous telemedicine-naive centre: clinical challenges, outcomes, and user experience in the first six months of a global pandemic

Background: COVID-19 made it necessary to establish telemedicine as a first default for reviews in a previously telemedicine-naive clinic. Objectives: To establish and assess telemedicine in the first 6 months of COVID-19 pandemic. Methods: Utilising a multidisciplinary team (MDT) approach, we established a ‘Covid Pack’ of medical equipment (sent to each patient) and a suitable video conference platform to replicate the in-person clinic format. The virtual clinic was then rolled out (94 patients reviewed in the first 6 months). A retrospective chart review comparing patients’ clinical metrics pre- and post-rollout was then conducted. Usability and Acceptance were also measured with patients (p) and staff (s) via a number of standardised surveys: System Usability Scale (SUS), TeleHealth Usability Questionnaire (TUQ), IT Familiarity, and our own quality-survey. Results: The Covid Pack permits adequate spirometric assessment of patients (mean bias −2.5%). Preliminary data collected from 52 patients and 11 staff members show an overall positive response to our remoteclinics. The SUS received a median score of 90 (p) and 87.5 (s) out of 100. The TUQ received a total score of 6.52 (p) and 6.1 (s) out of 7, with ease of Use and Learnability as the highest-rated category in the TUQ (median 7, range 3.6–7) and Reliability as the lowest-rated category (median 5.33, range 2–7). The IT Familiarity questionnaire received an average median score of 1 (very familiar) from both groups. Qualitative data collected via a custom survey show that while patients and staff are positive to the convenience of the remote clinic, the facility for an in-person. face-to-face review remains important, as does good WiFi connection. Conclusion: Initial 6-month data are positive for the remote clinic as a first default during the pandemic. Preliminary data shows a positive trend for the usability and acceptance by all stakeholders, but it is not a replacement for physical clinics.

Who's talking about cystic fibrosis? The changing landscape of internet postings related to cystic fibrosis: a two-year comparative study

Background: Medical professionals are aware that patients continue to use the internet as a medical information source. With the advent of government campaigns to increase awareness of data privacy and information sources, we investigate how the landscape of internet postings has changed for CF and how this could affect patients seeking online medical information. Methods: Key phrases relating to CF were identified by a CF multidisciplinary team and entered in Google Alerts with prospective tracking for 6 months in 2015. Alerts were also created for 3 non-orphan lung diseases (asthma, chronic obstructive pulmonary disease and lung fibrosis). These steps were repeated again in 2019 and the data compared. Results: In 2015, Asthma received the highest mean number of alerts per day (31.7), followed by CF (16.1), then COPD (14.6), and Lung Fibrosis (5.1). This changed in 2019 where CF was the highest with 19.5, followed by Asthma (11.5), COPD (10.3), and Lung Fibrosis (7.4). In both years, the USA generated (56%) the highest number of alerts for CF. There was an increased number of blocked articles in 2019 (540). In 2015, News (58%) was the most common category for CF alerts, but this changed to Financial/Marketing (35%) in 2019. In 2015 there was a small number of Social Media alerts recorded for all lung conditions;however, in 2019, there were none for the comparative lung conditions and only 3 for CF. Alert frequency for CF-related terms also increased in 2019. Conclusion: The landscape for internet postings for CF has changed. CF is now more commonly reported than other lung conditions and the ‘business of CF’ is now more frequently reported online while content from the general public has decreased (or is private). Medical professionals need to remain vigilant and increase awareness of information-dilution by monetary based media. A limitation of this study is that it predated the COVID-19 pandemic and it is suggested that future works revisit this at an appropriate time.

Compassionate use triple therapy CFTR modulation (Kaftrio®) in severe disease. Single-centre, real-world clinical outcomes, safety and tolerability

Objective: Patients (F508del/F508del or F508del/MF) with severe CF (ppFEV1<40%) were not represented in the Phase 3 VX445 (Kaftrio®) [Table presented] clinical trials. We aimed to assess real-world efficacy, safety and tolerability in this cohort. Method: All patients with severe lung disease (ppFEV1<40%) attending our clinic eligible for Vertex's managed access programme who received treatment were assessed prospectively at 3 monthly intervals. Results: 7 of 8 patients remain on therapy. Irrespective of prior CFTR modulator therapy, notable improvements were observed (Table 1). After adjusting for time, there was a relative reduction of 68.89% IV and 21.43% PO antibiotic usage as well as a 66.9% reduction in hospital bed days. Improvements in CFQR-R and D domains and FACIT fatigue scores were observed. Patient 4 developed an erythematous diffuse rash on day 7 which resolved with antihistamines. No liver function abnormalities have been seen to date. Patient 6 died while on therapy due to multimorbidities including pulmonary embolism (Covid PCR and antibody negative), persistent pneumothorax and sepsis. Conclusion: This cohort demonstrates preliminary clinically meaningful real-world efficacy, safety and tolerability for patients (F/F, F/MF) with severe disease (ppFEV1<40%).

Virtual cystic fibrosis doctor: design, development, and user experience pilot study

Background: Patients often contact the cystic fibrosis (CF) multidisciplinary team (MDT) via phone to express health-related concerns in between the standard quarterly review. This often requires a phone evaluation before organising an unscheduled appointment. These sporadic interactions heavily affect available resources. This strain on resources will be further impacted when considering that data from the European CF registry predicts that there will be a 75% increase in the adult CF population by 2025. Furthering this, CF services are increasingly more strained now during the global Covid-19 pandemic. Objective: This research first sets about to design and develop a Virtual Doctor system based on the expertise of a MDT through multiple consultations. Next, pilot data pertaining to user acceptance and experience with using this novel technology is gathered. We therefore aim to investigate if the use of such technology can be beneficial in a specific clinical setting. Method: The final collaborative-design of the Virtual Doctor comprises several technical features and is primarily a voice synthesis system allowing the patient to interact with natural language. The virtual doctor asks the patient questions regarding their health concerns and can collect real-time clinical metrics such as FEV1, oxygen saturation, temperature. The patients’ responses and metrics are then compared to baseline values calculating a score which stratifies a response time from the CF team. This information is then collated in a report and sent to the CF team for action. Future works: Initial stress testing of the technical performance is now complete. Supportive visual media to improve coaching of using clinical devices have now been implemented in preparation for patient pilot testing which is currently ongoing. It is anticipated that a virtual system such as the Virtual Doctor will become more accessible and acceptable to patients, especially during the Covid-19 pandemic.

Introduction – building back a better world: The crisis and opportunity of covid-19*†

The current global pandemic of Covid-19 is a health and broader crisis of overwhelming proportions, threatening livelihoods, economies, and societies, particularly those already experiencing the greatest vulnerabilities. In putting the lives of millions of people at risk, creating uncertainties, heightening existing fragilities, and exacerbating inequalities, it has become a truly global challenge. Crisis also brings opportunity, however, and in addition to short-and mid-term responses, this is a time to explore and work towards a genuine transformation of ideas, policies, programmes, and practices. This may all be encapsulated in the overall notion of ‘building back a better world’. Against this backdrop, this article introduces this IDS Bulletin issue which asks, fundamentally, how we can collectively and equitably shape – and even transform – our shared future, in the light of experience of Covid-19, and what steps are necessary for us to do so. It draws upon strategic approaches guiding the efforts of two highly engaged organisations: Irish Aid, Ireland;and the Institute of Development Studies, UK. This editorial introduction explores lessons learned from the impact of Covid-19 by highlighting some key viewpoints and evidence provided in the articles3 that follow. It then offers a number of priority areas for action looking forward, as well as several principles that may help to guide those future actions in efforts to build back a better world. © 2021 The Authors. IDS Bulletin © Institute of Development Studies.