. 2022 Sep 2;23:737. doi: 10.1186/s13063-022-06566-5

Table 1.

Secondary endpoints

Safety of the TNF-α-antibody Infliximab in the treatment of patients with severe COVID-19
▶ Frequencies of adverse events (AEs) and serious adverse events (SAEs)
Assessment of the effect of infliximab on an excessive immune response in patients with COVID-19
▶ Change in the interleukin-6 (IL-6) concentration in blood from randomisation to day 7 (V₂) and day 14 (V₃) after randomisation
▶ Change in the ferritin concentration in blood from randomisation to day 7 (V₂) and day 14 (V₃) after randomisation
▶ Change in the lymphocyte count from randomisation to day 7 (V₂) and day 14 (V₃) after randomisation
Assessment of the effect of infliximab in patients with severe COVID-19 on morbidity and prognosis
▶ Ventilation-free days until day 28 (V₄) after randomisation
▶ Renal replacement therapy-free days until day 28 (V₄) after randomisation
▶ Vasopressor-free days until day 28 (V₄) after randomisation
▶ Rate of occurrence of severe acute respiratory syndrome (ARDS) until day 28 (V₄) after randomisation (Berlin criteria and PaO₂/FiO₂ ≤ 100 mmHg with PEEP ≥ 5 cmH₂O [19])
▶ WHO-COVID-19-Progression Scale on day 7 (V₂), 14 (V₃) and 28 (V₄) after randomisation
▶ Rate of admission to the intensive care unit after randomisation up to day 28 (V₄) after randomisation
▶ Length of hospital stay up to day 28 (V₄) after randomisation
▶ Length of intensive care unit stay up to day 28 (V₄) after randomisation
▶Mortality rates at day 14 (V₃) and day 90 (V₅) after randomisation
▶ EQ5D-3L (health-related quality of life): visual analogue scale value and sub-domain ratings at day 90 (V₅) after randomisation
▶ EQ5D-3L: index value at day 90 (V₅) after randomisation
▶ Frequencies of COVID-19 (long-term) sequelae (positive ratings in checklist)
▶ Incidence of cardiomyopathy at day 3 (V₁) and/or day 7 (V₂) after randomisation left-ventricular EF < 52 % in men and < 54 % in women, according to the American Society of Echocardiography [20] and the European Association of Cardiovascular Imaging or 10% reduction, if previously reduced [21–24]