SIMPLE study reports benefit from 5-day but not 10-day remdesivir on moderate COVID-19
26 June 2020. Related: COVID-19: investigational drugs, COVID-19.
Simon Collins, HIV i-Base
On 1 June 2020, top-line results were reported in a company press release from the phase 3 SIMPLE remdesivir study.
This study compared 5-day vs 10-day dosing vs standard of care (SoC) in people with moderate COVID-19 pneumonia but without reduced oxygen levels.
The primary endpoint was based on a 7-point scale of clinical symptoms at day 11.
The results reported that 5-day treatment significantly improved outcomes at day 11 compared to the control arm: OR 1.65 (95% CI: 1.09 to 2.48); p=0.017.
Results for the 10-day treatment however were not significantly different from the standard of care arm: OR 1.31 (95% CI: 0.88 to 1.95}; p=0.18.
The most common adverse events occurring in more than 5% of patients in both treatment groups were nausea (10% vs 9% vs 3%), diarrhoea (5% vs 5% vs 7%) and headache (5% vs 5% vs 3%), in 5-day vs 10-day vs SoC, respectively.
Key efficacy and safety results from the press release are included in Table 1.
Table 1: Key efficacy and safety results from SIMPLE study
|Clinical Efficacy Outcomes at Day 11|
|≥ 2-point improvement in ordinal scale||134 (70)||126 (65)||121 (61)|
|≥ 1-point improvement in ordinal scale||146 (76)||135 (70)||132 (66)|
|Requiring any oxygen support||12 (6)||13 (7)||22 (11)|
|≥ 1-point worsening in ordinal scale||6 (3)||12 (6)||22 (11)|
|Death||0||2 (1)||4 (2)|
|Any adverse event (AE)||97 (51)||106 (55)||90 (45)|
|Grade ≥3 AE||20 (10)||21 (11)||24 (12)|
|Any serious adverse event (SAE)||8 (4)||7 (4)||18 (9)|
Even when statistically significant, the summary result in Table 1 do not show especially large differences compared to the SoC inactive control arms. It is also difficult to understand why slightly longer treatment would not replicate the 5-day treatment.
Nevertheless, these results will be used to support 5-day dosing, which will ensure twice as many people are able to access the limited supplies of remdesivir – both in expanded access and when fully available.
Giiead press statement. Gilead announces results from phase 3 trial of remdesivir in patients with moderate COVID-19. (1 June 2020).