Objective: The trial objective is to determine if Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) is clinically effective compared to standard oxygen therapy in patients with confirmed or suspected COVID-19. Trial design: Adaptive (group-sequential), parallel group, pragmatic, superiority randomised controlled, open-label, multi-centre, effectiveness trial. Participants: The trial is being conducted across approximately 60 hospitals across England, Wales, Scotland, and Northern Ireland. Inpatients at participating hospitals are eligible to participate if they have respiratory failure with suspected or proven COVID-19, and meet all of the inclusion criteria and none of the exclusion criteria. Inclusion criteria: 1) Adults ≥ 18 years; 2) Admitted to hospital with suspected or proven COVID-19; 3) Receiving oxygen with fraction of inspired oxygen (FiO 2) ≥0.4 and peripheral oxygen saturation (SpO 2) ≤94%; and 4) Plan for escalation to tracheal intubation if needed. Exclusion criteria: 1) Planned tracheal intubation and mechanical ventilation imminent within 1 hour; 2) Known or clinically apparent pregnancy; 3) Any absolute contraindication to CPAP or HFNO; 4) Decision not to intubate due
On February 26, 2020, the first case of community spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States (US) was confirmed. 1 SARS-CoV-2 causes coronavirus disease 2019 (COVID-19), and on March 11, the World Health Organization declared COVID-19 a global pandemic. By May 27, 2020, SARS-CoV-2 had infected over 1.6 million people in the United States, resulting in over 100 000 deaths. 2 The ongoing pandemic has presented a challenging predicament for organ transplantation programs. The combination of a protracted asymptomatic incubation period of SARS-CoV-2 and the lack of capacity for rapid testing of potential donors to avoid transmission of SARS-CoV-2 were challenges to transplant programs. 3 Further, the effects of SARS-CoV-2 in highly immunosuppressed patients in the early post-transplant period are currently unclear. Nonetheless, it has been assumed that any significant viral infection in this patient cohort would be detrimental, which has been demonstrated in early reports. 4 In addition, cardiovascular disease has emerged as a risk factor for mortality with COVID-19. 5 Indeed, the number of patients inactivated on the heart transplant waitlist more than doubled between the weeks of March 8 and
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