Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial.

Background The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers. Methods The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course. The primary end point was the percentage of subjects who tested positive for IgGS (anti-spike, immunoglobulin G specific to the spike protein of SARS-CoV-2) at day 45. Results Between 16th April 2021 and 26th July 2021, 556 participants were analysed for the primary endpoint (275 Test; 281 Placebo). The test agent significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18-0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27-0.59), p < 0.0001]. No harmful effects were associated with taking the test agent. Conclusion The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.

Cardiothoracic surgery in the midst of a pandemic: Operative outcomes and maintaining a coronavirus disease 2019 (COVID-19)-free environment.

OBJECTIVE: In the United Kingdom, the coronavirus disease 2019 (COVID-19) pandemic has led to the cessation of elective surgery. However, there remains a need to provide urgent and emergency cardiac and thoracic surgery as well as to continue time-critical thoracic cancer surgery. This study describes our early experience of implementing a protocol to safely deliver major cardiac and thoracic surgery in the midst of the pandemic. METHODS: Data on all patients undergoing cardiothoracic surgery at a single tertiary referral center in London were prospectively collated during the first 7 weeks of lockdown in the United Kingdom. A comprehensive protocol was implemented to maintain a COVID-19-free environment including the preoperative screening of all patients, the use of full personal protective equipment in areas with aerosol-generating procedures, and separate treatment pathways for patients with and without the virus. RESULTS: A total of 156 patients underwent major cardiac and thoracic surgery over the study period. Operative mortality was 9% in the cardiac patients and 1.4% in thoracic patients. The preoperative COVID-19 protocol implemented resulted in 18 patients testing positive for COVID-19 infection and 13 patients having their surgery delayed. No patients who were negative for COVID-19 infection on preoperative screening tested positive postoperatively. However, 1 thoracic patient tested positive on intraoperative bronchoalveolar lavage. CONCLUSIONS: Our early experience demonstrates that it is possible to perform major cardiac and thoracic surgery with low operative mortality and zero development of postoperative COVID-19 infection.

Outcomes of patients diagnosed with COVID-19 in the early postoperative period following cardiac surgery.

The coronavirus 2019 (COVID-19) pandemic has disrupted patient care across the NHS. Following the suspension of elective surgery, priority was placed in providing urgent and emergency surgery for patients with no alternative treatment. We aim to assess the outcomes of patients undergoing cardiac surgery who have COVID-19 infection diagnosed in the early postoperative period. We identified 9 patients who developed COVID-19 infection following cardiac surgery. These patients had a significant length of hospital stay and extremely poor outcomes with mortality of 44%. In conclusion, the outcome of cardiac surgical patients who contracted COVID-19 infection perioperatively is extremely poor. In order to offer cardiac surgery, units must implement rigorous protocols aimed at maintaining a COVID-19 protective environment to minimize additional life-threatening complications related to this virus infection.

A nationwide survey of UK cardiac surgeons' view on clinical decision making during the coronavirus disease 2019 (COVID-19) pandemic.

BACKGROUND: No firm recommendations are currently available to guide decision making for patients requiring cardiac surgery during the coronavirus disease 2019 (COVID-19) pandemic. Systematic appraisal of senior surgeons' consensus can be used to generate interim recommendations until data from clinical observations become available. Hence, we aimed to collect and quantitatively appraise nationwide UK consultants' opinions on clinical decision making for patients requiring cardiac surgery during the COVID-19 pandemic. METHODS: We E-mailed a Web-based questionnaire to all consultant cardiac surgeons through the Society for Cardiothoracic Surgery in Great Britain and Ireland mailing list on the April 17, 2020, and we predetermined to close the survey on the April 21, 2020. This survey was primarily designed to gather information on UK surgeons' opinions using 12 items. Strong consensus was predefined as an opinion shared by at least 60% of responding consultants. RESULTS: A total of 86 consultant surgeons undertook the survey. All UK cardiac units were represented by at least 1 consultant. Strong consensus was achieved for the following key questions: (1) before any hospital admission for cardiac surgery, nasopharyngeal swab, polymerase chain reaction, and computed tomography of the chest should be performed; (2) the use of full personal protective equipment should to be adopted in every case by the theater team regardless of the patient's COVID-19 status; (3) the risk of COVID-19 exposure for patients undergoing heart surgery should be considered moderate to high and likely to increase mortality if it occurs; and (4) cardiac procedures should be decided based on a rapidly convened multidisciplinary team discussion for every patient. The majority believed that both aortic and mitral surgery should be considered in selected cases. The role of coronary artery bypass graft surgery during the pandemic was controversial. CONCLUSIONS: In this unprecedented pandemic period, this survey provides information for generating interim recommendations until data from clinical observations become available.