Background EXO-CD24 is a novel inhaled drug of exosomes displaying CD24, a protein with anti-inflammatory properties. We evaluated the safety and potential efficacy of EXO-CD24, in a phase II, randomized, single-blinded clinical trial of EXO-CD24 in hospitalized patients with moderate or severe COVID-19, following the preliminary safety and efficacy results of a phase 1 study (ClinicalTrials.gov: NCT04747574). Methods Two tertiary care hospitals in Athens, Greece participated. Patients received either 109 or 1010 exosome particles per dose, once per day for 5 days and were followed for 28 days. Safety and efficacy measures (including respiratory rate < 23 b/min and pulse oximetry SpO2≥ 94% on room air, oxygen need and levels of inflammatory biomarkers i.e. CRP, LDH, ferritin, fibrinogen and d-dimers) were compared between groups at days 3, 5 and 7. A separate analysis was conducted comparing the clinical course of treated patients with that of a control cohort (n=70 patients) matched by propensity scoring out of a similar period hospitalized cohort (n=202) that did not participate in the study. Results Between June 9th and August 3rd 2021, 91 patients underwent randomization: 45 in group A and 46 in group B (109vs. 1010 exosome particles per dose). Mean age was 49.4 (± 13.2) years and 74.4% were male. Mean time from symptom onset to randomization was 8 days. Improvement in respiratory rate and pulse oximetry was noted in 72 out of 86 (83.7%) and 55 out of 86 (64%) analyzed patients. Day 7 inflammatory indices levels dropped at least 50% from baseline admission values in 72 out of 86 (82.8%) analyzed patients (p< 0.001). No treatment-related adverse events were reported. Comparison with the propensity score matched group showed statistically significant differences in the same parameters (p≤ 0.01 for all comparisons). Conclusion Our results suggest safety and potential efficacy of EXO-CD24 on clinical and laboratory parameters of moderate or severe COVID-19, that deserve further investigation in a phase 3 study. (Funded by Athens Medical Society. ClinicalTrials.gov: NCT04902183, EU Clinical Trials Register EudraCT Number 2021-002184-22). Disclosures All Authors: No reported disclosures.
A realistic and well-received intervention to improve the teaching of newly qualified doctors, which is feasible in the modern, busy health care setting. Other institutions may find this method and its resources valuable. Newly qualified doctors are currently an underused resource in terms of teaching one another.
BACKGROUND: Since the outbreak of the coronavirus (SARS-Cov-2), wearing personal protective equipment (PPE) has become necessary. Patients’ ability to recognize staff is disrupted impacting on the relationship between healthcare worker and patient. OBJECTIVE: Assess the patients’ perspective of healthcare workers wearing PPE and its effect on communication. METHODS: Admitted Orthopaedic patients during the first wave of SARS-Cov-2 were surveyed about the experience with staff wearing PPE. In response to feedback, individual badges with large pictures and names were introduced to wear over PPE. Patient views and response to the badges was collected from surveying admitted patients. RESULTS: Patients encountered staff wearing face masks and felt this was appropriate in the context of the pandemic. 44% responded that they would prefer staff wearing badges with names, roles and pictures more visible. Following the introduction of badges, patients were better able to recognize staff roles and remember names. Hospital staff felt this was a positive change to help improve rapport while wearing PPE. CONCLUSION: Wearing PPE affects patients’ ability to recognize individuals in a fast-paced environment such as an acute hospital. Introducing badges was an intervention based on patient feedback and an important adaptation to sustained PPE use to improve the patient’s experience.
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