15 septiembre 2021

Remdesisivir , Resultados de Fase III Confirmatorios : No se Observó ¡¡ Ningún Beneficio Clínico !! del Uso de Remdesivir en Pacientes Que Ingresaron en el Hospital por COVID19, Estuvieron Sintomáticos Durante Más de 7 Días y Requirieron Soporte de Oxígeno . Post By The Lancet .

 No Hubo Diferencias Significativas en la Aparición de Eventos Adversos Graves Entre los Grupos de Tratamiento ( Remdesivir, 135 [33%] de 406 vs.Control, 130 [31%] de 418; p = 0 · 48 ) . 

The Antiviral Efficacy of Remdesisivir Against SARS-CoV-2 is Still Controversial .


We Aimed To Evaluate The Clínical Efficacy of Remdesisivir Plus Standard of Care Compared With Standard of Care Alone in Patients Admitted to Hospital With COVID19, With Indication of Oxygen or Ventilator Support .

Between March 22, 2020, and Jan 21, 2021, 857 participants were enrolled and randomly assigned to remdesivir plus standard of care (n=429) or standard of care only (n=428). 15 participants were excluded from analysis in the remdesivir group, and ten in the control group. At day 15, the distribution of the WHO ordinal scale was: (1) not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]). The difference between treatment groups was not significant (odds ratio 0·98 [95% CI 0·77–1·25]; p=0·85). There was no significant difference in the occurrence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406 vs control, 130 [31%] of 418; p=0·48). Three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) were considered related to remdesivir by the investigators, but only one by the sponsor's safety team (hepatorenal syndrome).


Interpretation


No Clínical Benefit Was Observed From The Use of Remdesivir in Patients Who Were Admitted to Hospital For COVID19, Were Symptomatic For More Than 7 Days, and Required Oxygen Support .