{"id":38283,"date":"2020-06-26T07:26:16","date_gmt":"2020-06-26T07:26:16","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38283"},"modified":"2020-06-26T09:52:07","modified_gmt":"2020-06-26T09:52:07","slug":"simple-study-reports-benefit-from-5-day-but-not-10-day-remdesivir-on-moderate-covid-19","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38283","title":{"rendered":"SIMPLE study reports benefit from 5-day but not 10-day remdesivir on moderate COVID-19"},"content":{"rendered":"

<\/span>Simon Collins, HIV i-Base<\/strong><\/p>\n

On 1 June 2020, top-line results were reported in a company press release from the phase 3 SIMPLE remdesivir study.<\/strong><\/p>\n

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.<\/p>\n

The primary endpoint was based on a 7-point scale of clinical symptoms at day 11.<\/p>\n

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.<\/p>\n

Results for the 10-day treatment however were not significantly different from the standard of care arm: OR 1.31\u00a0(95% CI: 0.88 to 1.95}; p=0.18.<\/p>\n

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.<\/p>\n

Key efficacy and safety results from the press release are included in Table 1.<\/p>\n\n

Table 1: Key efficacy and safety results from SIMPLE study<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\n5-Day RDV
\nn=191<\/td>\n		10-Day RDV
\nn=193<\/td>\n		SoC
\nn=200<\/td>\n<\/tr>\n
Clinical Efficacy Outcomes at Day 11<\/strong><\/td>\n<\/tr>\n
\u2265 2-point improvement in ordinal scale<\/td>\n134 (70)<\/td>\n126 (65)<\/td>\n121 (61)<\/td>\n<\/tr>\n
\u2265 1-point improvement in ordinal scale<\/td>\n146 (76)<\/td>\n135 (70)<\/td>\n132 (66)<\/td>\n<\/tr>\n
Requiring any oxygen support<\/td>\n12 (6)<\/td>\n13 (7)<\/td>\n22 (11)<\/td>\n<\/tr>\n
\u2265 1-point worsening in ordinal scale<\/td>\n6 (3)<\/td>\n12 (6)<\/td>\n22 (11)<\/td>\n<\/tr>\n
Death<\/td>\n0<\/td>\n2 (1)<\/td>\n4 (2)<\/td>\n<\/tr>\n
Safety<\/strong><\/td>\n<\/tr>\n
Any adverse event (AE)<\/td>\n97 (51)<\/td>\n106 (55)<\/td>\n90 (45)<\/td>\n<\/tr>\n
Grade \u22653 AE<\/td>\n20 (10)<\/td>\n21 (11)<\/td>\n24 (12)<\/td>\n<\/tr>\n
Any serious adverse event (SAE)<\/td>\n8 (4)<\/td>\n7 (4)<\/td>\n18 (9)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

comment<\/h3>\n

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.<\/strong><\/p>\n

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.<\/strong><\/p>\n

Reference<\/p>\n

Giiead press statement. Gilead announces results from phase 3 trial of remdesivir in patients with moderate COVID-19. (1 June 2020).
\nhttps:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2020\/6\/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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 …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-38283","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38283","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=38283"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38283\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38283"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38283"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}