Break Up schreef op 5 juni 2020 12:45:
Toch een beetje time indicatie. overigens als je de FDA trial page opent kun je in die tab's voldoende info vinden.
Current Secondary Outcome Measures ICMJE
(submitted: June 2, 2020)
Time to clinical improvement [ Time Frame: within 14 days after enrolment ]
Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)
Proportion of participants alive and not having required invasive or non-invasive ventilation [ Time Frame: at 14 days after enrolment ]
Proportion of participants alive and not having required invasive or non-invasive ventilation
Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg) [ Time Frame: within 14 days after enrolment ]
Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)
Original Secondary Outcome Measures ICMJE Same as current
Current Other Pre-specified Outcome Measures
(submitted: June 2, 2020)
Changes in the ordinal WHO scale [ Time Frame: from baseline over 14 days ]
Changes in the ordinal WHO scale
Length of hospital stay in survivors [ Time Frame: until day 28 ]
Length of hospital stay in survivors
Proportion of participants progressing to mechanical ventilation [ Time Frame: on day 7 and day 14 ]
Proportion of participants progressing to mechanical ventilation
Proportion of participants requiring ICU treatment [ Time Frame: on day 7 and 14 ]
Proportion of participants requiring ICU treatment
Length of ICU stay [ Time Frame: until day 28 ]
Length of ICU stay
28 Ventilator-free days [ Time Frame: until day 28 ]
28 Ventilator-free days
All-cause mortality [ Time Frame: time from randomisation to death within four weeks ]
All-cause mortality
Changes in biomarker level CRP (mg/l) [ Time Frame: until day 14 ]
Changes in biomarker level CRP
Changes in biomarker level LDH (U/l) [ Time Frame: until day 14 ]
Changes in biomarker level LDH
Changes in biomarker level D- Dimer (yg/ml) [ Time Frame: until day 14 ]
Changes in biomarker level D-Dimer
Changes in biomarker level Ferritin (ng/ml) [ Time Frame: until day 14 ]
Changes in biomarker level Ferritin
Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml) [ Time Frame: until day 14 ]
Changes in biomarker level IL-6
Changes in lymphocyte count (cells per microliter of blood) [ Time Frame: until day 14 ]
Changes in lymphocyte count
Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples [ Time Frame: time from enrolment to first of 2 negative assays at least 12 hours apart ]
Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples
Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins [ Time Frame: within 14 days ]
Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins
Time to defervescence (temperature <38.0°C) [ Time Frame: sustained for at least 48 hours ]
Time to defervescence (temperature <38.0°C)
Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28 [ Time Frame: until day 28 ]
Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)
Duration of supplemental oxygen [ Time Frame: until day 28 ]
Duration of supplemental oxygen
Change in pharmacokinetics of conestat alfa [ Time Frame: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date ]
Peak serum concentration of conestat alfa will be measured
Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration) [ Time Frame: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date ]
Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)
Original Other Pre-specified Outcome Measures Same as current