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Posted On: 09/15/2021 3:31:23 PM
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SEPTEMBER 15, 2021
Remdesivir plus standard of care compared with standard of care alone in patients hospitalised with COVID-19
No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for coronavirus disease 2019 (COVID-19), were symptomatic for more than 7 days, and required oxygen support, according to a study published in The Lancet Infectious Diseases.
“We found no significant difference in the clinical status at days 15 and 29, time to hospital discharge, 28-day all-cause mortality, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral kinetics in participants receiving standard of care alone compared with standard of care plus remdesivir. No significant difference in the occurrence of serious adverse events was observed between groups,” reported Prof Florence Ader, MD, Hôpital de la Croix-Rousse, Lyon, France, and colleagues.
DisCoVeRy was a Phase III randomised controlled trial conducted in 48 sites in Europe. Adult patients admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation.
Between March 22, 2020, and January 21, 2021, 832 patients with moderate (n = 504) or severe (n = 328) COVID-19 were randomly assigned to remdesivir plus standard of care (n = 418) or standard of care only (n = 414). The median age of the participants was 64 years and the median period from symptoms onset to randomisation was 9 days. Most of the patients were on oxygen support with nasal canula or face mask (59%), followed by high-flow oxygen device (18%) and invasive mechanical ventilation (18%).
Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-hour infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged.
At day 15, the distribution of the World Health Organization (WHO) ordinal scale among patients in the remdesivir group compared to those in the standard of care group was:
not hospitalised, no limitations on activities (15% vs 17%);
not hospitalised, limitation on activities (31% vs 32%);
hospitalised, not requiring supplemental oxygen (12% vs 7%);
hospitalised, requiring supplemental oxygen (18% vs 16%);
hospitalised, on non-invasive ventilation or high flow oxygen devices (4% vs 3%);
hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (15% vs 19%);
death (5% vs 6%).
Overall, there was no significant difference in the distribution of the seven-point WHO ordinal scale at day 15 between the remdesivir and control groups (odds ratio [OR] 0·98, 95% confidence interval [CI] 0·77–1·25, P = 0·85). Similarly, no significant difference was observed between the remdesivir and control groups in the distribution of the seven-point ordinal scale at day 29 (OR 1·11, 95% CI 0·87 to 1·42, P = 0·39).
In addition, study data demonstrated no significant between-group difference in time to hospital discharge within 29 days (hazard ratio [HR] 0·94, 95% CI 0·80-1·11, P = 0·49) or 28-day all-cause mortality (OR 0·93, 95% CI 0·57-1·52, P = 0·77). Further, there was no significant effect of remdesivir on the viral kinetics (P = 0.75), with no significant difference being observed between the groups in the proportion of participants with detectable viral loads at each sampling time.
Safety analysis showed that occurrence of serious adverse events was similar among patients in the remdesivir and standard of care groups (33% vs 31%, P = 0·48).
“In this randomised controlled trial, the use of remdesivir for the treatment of hospitalised patients with COVID-19 was not associated with clinical improvement at day 15 or day 29, nor with a reduction in mortality, nor with a reduction in SARS-CoV-2 RNA,” the authors concluded. “Together with previous evidence, results from the DisCoVeRy trial do not support the use of remdesivir in hospitalised patients with COVID-19 in a population with symptoms for more than a week and requiring oxygen support.”
Reference: https://www.thelancet.com/journals/laninf/art...0/fulltext
SOURCE: The Lancet Infectious Diseases
Remdesivir plus standard of care compared with standard of care alone in patients hospitalised with COVID-19
No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for coronavirus disease 2019 (COVID-19), were symptomatic for more than 7 days, and required oxygen support, according to a study published in The Lancet Infectious Diseases.
“We found no significant difference in the clinical status at days 15 and 29, time to hospital discharge, 28-day all-cause mortality, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral kinetics in participants receiving standard of care alone compared with standard of care plus remdesivir. No significant difference in the occurrence of serious adverse events was observed between groups,” reported Prof Florence Ader, MD, Hôpital de la Croix-Rousse, Lyon, France, and colleagues.
DisCoVeRy was a Phase III randomised controlled trial conducted in 48 sites in Europe. Adult patients admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation.
Between March 22, 2020, and January 21, 2021, 832 patients with moderate (n = 504) or severe (n = 328) COVID-19 were randomly assigned to remdesivir plus standard of care (n = 418) or standard of care only (n = 414). The median age of the participants was 64 years and the median period from symptoms onset to randomisation was 9 days. Most of the patients were on oxygen support with nasal canula or face mask (59%), followed by high-flow oxygen device (18%) and invasive mechanical ventilation (18%).
Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-hour infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged.
At day 15, the distribution of the World Health Organization (WHO) ordinal scale among patients in the remdesivir group compared to those in the standard of care group was:
not hospitalised, no limitations on activities (15% vs 17%);
not hospitalised, limitation on activities (31% vs 32%);
hospitalised, not requiring supplemental oxygen (12% vs 7%);
hospitalised, requiring supplemental oxygen (18% vs 16%);
hospitalised, on non-invasive ventilation or high flow oxygen devices (4% vs 3%);
hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (15% vs 19%);
death (5% vs 6%).
Overall, there was no significant difference in the distribution of the seven-point WHO ordinal scale at day 15 between the remdesivir and control groups (odds ratio [OR] 0·98, 95% confidence interval [CI] 0·77–1·25, P = 0·85). Similarly, no significant difference was observed between the remdesivir and control groups in the distribution of the seven-point ordinal scale at day 29 (OR 1·11, 95% CI 0·87 to 1·42, P = 0·39).
In addition, study data demonstrated no significant between-group difference in time to hospital discharge within 29 days (hazard ratio [HR] 0·94, 95% CI 0·80-1·11, P = 0·49) or 28-day all-cause mortality (OR 0·93, 95% CI 0·57-1·52, P = 0·77). Further, there was no significant effect of remdesivir on the viral kinetics (P = 0.75), with no significant difference being observed between the groups in the proportion of participants with detectable viral loads at each sampling time.
Safety analysis showed that occurrence of serious adverse events was similar among patients in the remdesivir and standard of care groups (33% vs 31%, P = 0·48).
“In this randomised controlled trial, the use of remdesivir for the treatment of hospitalised patients with COVID-19 was not associated with clinical improvement at day 15 or day 29, nor with a reduction in mortality, nor with a reduction in SARS-CoV-2 RNA,” the authors concluded. “Together with previous evidence, results from the DisCoVeRy trial do not support the use of remdesivir in hospitalised patients with COVID-19 in a population with symptoms for more than a week and requiring oxygen support.”
Reference: https://www.thelancet.com/journals/laninf/art...0/fulltext
SOURCE: The Lancet Infectious Diseases
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