Created at Source Raw Value Validated value
Aug. 13, 2021, 4:30 p.m. usa

- 1) embarazo y lactancia - 2) situación terminal o esperanza de vida inferior a 30 días a juicio del investigador - 3) alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80) - 4) interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente - 5) transaminasas elevadas por encima de cinco veces el límite superior de la normalidad - 6) severe neutropenia (<500 cells / mm3) - 7) plaquetopenia <50,000 / mm3 - 8) sepsis (clinical suspicion of active infection at another level with a value on the qsofa scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65 mmhg, with a lactate of more 2 mmol / l, despite adequate volume replacement - 9) another active infection at any level - 10) complicated diverticulitis or intestinal perforation - 11) renal failure with estimated glomerular filtration rate less than 30 ml / min - 12) hepatic failure (child b onwards) - 13) previous use (during the acute process or as chronic medication for another reason) of medication with a potential effect in this phase of the disease (janus kinase inhibitors, interleukin 1 inhibitors, other immunosuppressants or immunomodulators that in the opinion of the investigator could have an effect on the disease based on pathophysiological criteria or on previous research or started in this same period). clarification: the use of dexamethasone according to the recovery study guideline or corticosteroid therapy at equivalent doses will not be included at this point. - 14) being included in another clinical trial - 15) patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study

- 1) embarazo y lactancia - 2) situación terminal o esperanza de vida inferior a 30 días a juicio del investigador - 3) alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80) - 4) interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente - 5) transaminasas elevadas por encima de cinco veces el límite superior de la normalidad - 6) severe neutropenia (<500 cells / mm3) - 7) plaquetopenia <50,000 / mm3 - 8) sepsis (clinical suspicion of active infection at another level with a value on the qsofa scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65 mmhg, with a lactate of more 2 mmol / l, despite adequate volume replacement - 9) another active infection at any level - 10) complicated diverticulitis or intestinal perforation - 11) renal failure with estimated glomerular filtration rate less than 30 ml / min - 12) hepatic failure (child b onwards) - 13) previous use (during the acute process or as chronic medication for another reason) of medication with a potential effect in this phase of the disease (janus kinase inhibitors, interleukin 1 inhibitors, other immunosuppressants or immunomodulators that in the opinion of the investigator could have an effect on the disease based on pathophysiological criteria or on previous research or started in this same period). clarification: the use of dexamethasone according to the recovery study guideline or corticosteroid therapy at equivalent doses will not be included at this point. - 14) being included in another clinical trial - 15) patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study