Remdesivir does not reduce mortality in ventilated patients with COVID-19

1. No significant decrease in mortality risk was observed in ventilated patients with COVID-19 on remdesivir compared to the control group.

2. In patients infected with COVID-19 who were not ventilated at the time of randomization, there was a slight reduction in mortality in patients on remdesevir compared to the control group (p=0.02) .

Level of evidence assessment: 1 (Excellent)

Summary of the study: The Solidarity trial is a previously reported large study of four potential drug treatments for COVID-19 conducted by the World Health Organization (WHO). The drugs included were remdesivir, hydroxychloroquine, lopinavir and IFN-β1a. Due to lack of supporting evidence, all three drugs other than remdesivir were discontinued after the interim report; therefore, follow-up results focus only on remdesivir. Patients were randomized to receive standard care plus remdesivir or no medication (control). This study found no statistically significant difference in all-cause mortality between the remdesivir group and the control group. Patients were then stratified by disease severity defined by the use of respiratory support or supplemental oxygen. When disease severity is taken into account, remdesivir was found to confer a reduced risk of mortality in less severe illnesses (no oxygen or respiratory support). In non-ventilated patients, remdesivir significantly reduced the risk of death and the risk of progression to ventilation, but this benefit was small. Limitations of this study include the lack of a placebo and therefore the inherently open design. Nevertheless, drug trials during the COVID-19 pandemic were a necessity to assess promising drugs and therefore required a more flexible design. This study demonstrates the need for additional therapy to effectively combat COVID-19 infection.

Click to read the study in The Lancet

Relevant reading: Antiviral drugs repurposed for COVID-19: interim results from WHO solidarity trials

In depth [randomized controlled trial]: The Solidarity trial enrolled 14,221 patients between March 22, 2020 and January 29, 2021. The patients were 18 years old with a clinical diagnosis of COVID-19 with no positive PCR test required. Severity of illness was defined by the use of ventilation and supplemental oxygen. Participants were randomized to receive remdesivir, hydroxychloroquine, lopinavir, IFN-β1a, or no study drug (no placebo) in addition to standard treatment. Control groups were created for each medication using participants who received no study medication. The study ultimately only continued with remdesivir and dropped the other drugs due to lack of efficacy. A total of 4146 patients received remdesivir and 4129 patients received no study (control) drug. In terms of all-cause mortality, no statistically significant benefit was observed with remdesivir compared to control (rate ratio [RR] 0.91 [95% CI 0.82-1.02], p=0.12). When stratified by disease severity, the RR for remdesivir versus control was 0.76 in those not taking oxygen (p=0.30), 0.87 for those taking supplemental oxygen (p = 0.03) and 1.13 for those who were already on respiratory assistance (p = 0.32). This suggests that remdesivir might have a greater effect in less severe cases (p=0.05). Remdesivir was associated with a lower risk of switching to respiratory support in those not yet ventilated compared to the control group (RR 0.88, p=0.04). Combining the results of death and progression to ventilation in those not receiving respiratory support, there was a lower risk seen with remdesivir compared to control (0.84, p=0.001), but this effect is weak (19.6% against 22.5%).

Picture: PD

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