Study design
acute respiratory failure
VIRAL PNEUMONIA, ACUTE RESPIRATORY FAILURE
This is a pilot, exploratory, dose-adaptive, prospective, randomized, phase-2, open-label, proof-of-concept trial to assess the feasibility, safety, and efficacy of nebulized surfactant (Alveofact®, bovactant) in adult COVID-19 patients requiring mechanical ventilation (NCT04362059, date of registration 24/04/2020). The trial was conducted in the intensive care units at University Hospital Southampton (UK) and University College Hospitals London (UK)Eligible participants were 18 years of age or older, admitted to the intensive care unit and requiring invasive mechanical ventilation for acute respiratory failure following a positive respiratory sample real-time polymerase chain reaction (RT-PCR) SARS-CoV-2 test. All patients had radiological evidence of SARS-CoV-2 viral pneumonia and enrolled within 24 h of endotracheal intubation. The study was conducted between October 2020 and December 2021. Between 14th of October 2020 and 12th of November 2021, 77 patients were assessed for eligibility, and 20 patients were randomized. The University Hospital Southampton and University College Hospital London enrolled 13 and 7 participants respectively. One patient from the control group was transferred to the regional Extracorporeal Membrane oxygenation (ECMO) centre for additional support before study assessment at 48 h, leaving 19 participants for the primary analysis (Fig. Consort diagram for enrolment and randomization.