Repair of acute respiratory distress syndrome in COVID-19 by stromal cells (REALIST-COVID trial): 1 year follow up for safety and pulmonary dysfunction

S44 Table 1Summary of significant medical events, thoracic computed tomography (CT) and pulmonary function tests (PFTs) in ORBCEL-C and placebo groups at 1 year follow upORBCEL-C Placebo Number of patients followed up 20 21 Significant medical events Number of patients with SMEs 6/20 9/21 Total SME events 7 11 Classification Respiratory,thoracic and mediastinal disorders 4 6 Neoplasm - benign, malignant, unspecified 1 0 Infections and infestations 1 1 Cardiac disorders 1 0 Metabolism and nutrition disorders 0 1 Injury, poisoning and procedural complications 0 1 Renal and urinary disorders 0 1 Gastrointestinal disorders 0 1 Thoracic CT Number of CTs available 5 8 Time to CT (Median, IQR) 181 (157–198) 203 (95–233) Evidence of ILD on CT 4 6 PFTs Number of PFTs available 10 8 Time to PFTs (Median, IQR) 184.5 (117.5–292.75) 203.5 (118.25–242.5) FEV1 (Mean, SD) 84.9 (13.6) 80.5 (13.3) FEV1 <80% predicted (n,%) 4/10 (44%) 4/8 (50%) FVC (Mean, SD) 78.4 (13.2) 79.3 (16.5) FVC <80% predicted (n,%) 5/10 (55%) 5/8 (62.5%) FEV1/FVC ratio (Mean, SD, n) 0.88 (0.12) N=8 0.76 (0.05) N=5 FEV1/FVC <0.7 (n,%) 0 (0%) 0 (0%) TLCO (Mean, SD, n) 78.9 (14.8) N=9 61.9 (13.4) N=7 TLCO <80% (n,%) 6/9 (66.7%) 7/7 (100%) ConclusionsOne year follow up supports the safety of ORBCEL-C MSCs in patients with moderate to severe ARDS due to COVID-19. A similar incidence of pulmonary dysfunction is reported in both groups at long term follow up.Please refer to page A?? for declarations of interest related to this .

Conscious prone positioning of patients with COVID-19 pneumonitis: An audit of practice in the Northwest of England

Introduction: Prior to the COVID-19 pandemic, evidence in favour of prone positioning was mainly limited to mechanically ventilated patients with ARDS.1 Although there were some reports of oxygenation improvement following conscious prone positioning (CPP) in non ventilated patients, 2,3 this intervention was largely unknown outside of critical care units. The pandemic imposed extraordinary pressures on hospitals, encouraging medical teams to innovate and consider CPP in patients with increasing oxygen requirements.4 In April 2020, the Intensive Care Society (ICS) issued guidance for CPP of patients presenting respiratory failure secondary to COVID-19.5 Objectives: The objectives of the study were to assess the practice of CPP and the compliance to ICS guidance in the Northwest of England. We also aimed to evaluate the feasibility of proning and to appraise the impact of position changes on oxygenation. The study was also an opportunity to encourage multidisciplinary teams to consider CPP as a therapeutic tool for patients admitted with COVID-19 pneumonitis in non-critical care areas. Methods: This was a pragmatic observational prospective cohort study conducted over five weeks in May and June 2020 across seven different hospitals in the Northwest of England. We attempted to capture as many episodes of CPP as possible during this period. We collected various demographics and clinical data related to the patients and to the intervention of proning. We followed up the patients for 28 days from their first episode of CPP. A descriptive statistical analysis was performed using Excel. Results: Overall, 107 patients were included. Their mean age was 66 years and 55% were candidates for escalation to level 3 care. Among these patients 25% were eventually intubated. Table 1 shows more patients characteristics. A total of 246 episodes of CPP were recorded. Table 2 provides details about CPP episodes. The median duration was 4 hours. Proning was often conducted by patients and physiotherapists, as most (73%) didn't need assistance. CPAP was used simultaneously in a significant proportion (38%). One fifth of the CPP had to be discontinued, mostly because of discomfort. We focused on the first episode to assess practicalities and effect on oxygenation (Table 3). Only 9% of episodes were reported to follow ICS guidance as most interventions had to be tailored to local logistics and to patients' comfort. Thirteen per cent of CPP were initiated in morbidly obese patients despite it being mentioned as a relative contraindication. In terms of oxygenation, desaturation occurred within the first 15 minutes in 21% of cases. There was a tendency to improvement of FiO2 and SF ratio after 24 hours of the first CPP. Conclusion: In summary, a pragmatic approach often dictated departure from intensive care soceity guidance. Although CPP was largely feasible, it had to be adapted in most cases to the patients, their environment, the logistics, and their ventilatory support. It was often self-administered and didn't seem to be limited by morbid obesity for example. While the results and experience suggest a positive impact of CPP on oxygenation, only a well-designed comparative trial could determine the role of position changing in preventing intubation or death. The authors would like to thank the NWRAG and all the local team members, physiotherapists, nurses and doctors, who endeavoured to collect invaluable data under unprecedented clinical circumstances.

The impact of sleep, physical activity and sedentary behaviour on symptoms of depression and anxiety before and during the COVID-19 pandemic in a sample of South African participants.

During lockdowns associated with the COVID-19 pandemic, individuals have experienced poor sleep quality and sleep regularity, changes in lifestyle behaviours, and heightened depression and anxiety. However, the inter-relationship and relative strength of those behaviours on mental health outcomes is still unknown. We collected data between 12 May and 15 June 2020 from 1048 South African adults (age: 32.76 ± 14.43 years; n = 767 female; n = 473 students) using an online questionnaire. Using structural equation modelling, we investigated how insomnia symptoms, sleep regularity, exercise intensity/frequency and sitting/screen-use (sedentary screen-use) interacted to predict depressive and anxiety-related symptoms before and during lockdown. We also controlled for the effects of sex and student status. Irrespective of lockdown, (a) more severe symptoms of insomnia and greater sedentary screen-use predicted greater symptoms of depression and anxiety and (b) the effects of sedentary screen-use on mental health outcomes were mediated by insomnia. The effects of physical activity on mental health outcomes, however, were only significant during lockdown. Low physical activity predicted greater insomnia symptom severity, which in turn predicted increased depressive and anxiety-related symptoms. Overall, relationships between the study variables and mental health outcomes were amplified during lockdown. The findings highlight the importance of maintaining physical activity and reducing sedentary screen-use to promote better sleep and mental health.

Conventional oxygen therapy versus CPAP as a ceiling of care in ward-based patients with COVID-19: a multi-centre cohort evaluation

S52 Figure 1Kaplan-Meier curve comparing overall survival in the two treatment groups (conventional oxygen therapy vs continuous positive airway pressure therapy). The null hypothesis of no survival difference is evaluated with a log-rank test (p = 0.92)[Figure omitted. See PDF]DiscussionThis is, as far as we are aware, the first study comparing conventional oxygen therapy with CPAP in cohorts unaffected by physician selection. No survival difference was found between using oxygen alone or CPAP to treat patients with severe COVID-19 who were nIMV. A high patient-initiated discontinuation rate for CPAP suggests a significant treatment burden. Further reflection is warranted on the continued widespread use of CPAP in this patient group.Please refer to page A189 for declarations of interest related to this abstract.

Conventional oxygen therapy versus CPAP as a ceiling of care in ward-based patients with COVID-19: a multi-centre cohort evaluation.

BACKGROUND: Continuous positive airway pressure (CPAP) therapy is commonly used for respiratory failure due to severe COVID-19 pneumonitis, including in patients deemed not likely to benefit from invasive mechanical ventilation (nIMV). Little evidence exists demonstrating superiority over conventional oxygen therapy, whilst ward-level delivery of CPAP presents practical challenges. We sought to compare clinical outcomes of oxygen therapy versus CPAP therapy in patients with COVID-19 who were nIMV. METHODS: This retrospective multi-centre cohort evaluation included patients diagnosed with COVID-19 who were nIMV, had a treatment escalation plan of ward-level care and clinical frailty scale ≤ 6. Recruitment occurred during the first two waves of the UK COVID-19 pandemic in 2020; from 1st March to May 31st, and from 1st September to 31st December. Patients given CPAP were compared to patients receiving oxygen therapy that required FiO2 ≥0.4 for more than 12 hours at hospitals not providing ward-level CPAP. Logistic regression modelling was performed to compare 30-day mortality between treatment groups, accounting for important confounders and within-hospital clustering. FINDINGS: Seven hospitals provided data for 479 patients during the UK COVID-19 pandemic in 2020. Overall 30-day mortality was 75.6% in the oxygen group (186/246 patients) and 77.7% in the CPAP group (181/233 patients). A lack of evidence for a treatment effect persisted in the adjusted model (adjusted odds ratio 0.84 95% CI 0.57-1.23, p=0.37). 49.8% of patients receiving CPAP-therapy (118/237) chose to discontinue it. INTERPRETATION: No survival difference was found between using oxygen alone or CPAP to treat patients with severe COVID-19 who were nIMV. A high patient-initiated discontinuation rate for CPAP suggests a significant treatment burden. Further reflection is warranted on the current treatment guidance and widespread application of CPAP in this setting. FUNDING: L Pearmain is supported by the MRC (MR/R00191X/1). TW Felton is supported by the NIHR Manchester Biomedical Research Centre.