2.3. Trial Procedures
acute lung edema, respiratory failure, pneumonia
PNEUMONIA, RESPIRATORY FAILURE, RECRUITMENT, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, SUPERINFECTION
Randomization was carried out using the last digit of the patient’s medical record number (MRN). If the MRN ended in an odd number, the food supplement was administered (intervention) and if the MRN ended in an even number, the food supplement was not provided (control). All patients were treated following the treatment protocols of the center’s COVID-19 Committee, which were modified during the inclusion period based on published evidence (detailed information in the For the analysis, the COVID-19 patients were classified according the outcomes to be studied. Mainly, these were mortality, digestive symptoms and radiological involvement on admission by the diagnostic imaging service of Sagunto Hospital following the RALE scale (used for the severity of acute lung edema, differentiating between mild, moderate and severe involvement [As illustrated in In patients with radiological involvement included in the March–April 2020 period, treatment was mainly based on the use of hydroxychloroquine and azithromycin. In those with radiological worsening, progressive respiratory failure or analytical systemic inflammatory response syndrome criteria, anti-IL6 (Tocilizumab) plus systemic corticosteroids or immunoglobulin treatment was used in cases of bacterial superinfection. In the second stage of recruitment, between September and November 2020, treatment in patients with radiological involvement (mild, moderate or severe) and associated respiratory failure was based on the use of Remdesivir (if less than 7 days of evolution) and dexamethasone 6 mg (if more than 7 days of evolution). In cases of moderate or severe pneumonia with progressive respiratory failure or radiological worsening, we used methylprednisolone bolus (125 mg iv), Tocilizumab (anti-IL6), Anakinra (anti-IL1) or intravenous immunoglobulin, based on the characteristics of the patient. In addition to pharmacological treatment, respiratory support was the other basic pillar in the management of these patients, providing FiO2 from 24% to 100% according to the patient’s needs.