A Phase II/III Study of Sargramostim

Summary

This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.

Timeline

Start

2020-12-17

Primary completion

2021-10-25

Completion

2021-10-25

Publications

• Shimasaki S, Baba T, Ogura T, Akasaka K, Matsushima H, Izumi S, Takasaki J, Tsushima K, Kinouchi T, Kichikawa Y, Awashima M, Izumo T, Awano N, Nishimura N, Tazawa R, Mikami A, Kitamura N, Ishii H, Kurihara Y, Taniguchi M, Aikawa S, Okada M, Morita Y, Ishikawa Y, Ohinata A, Nakata K. Short-term inhalation of sargramostim with concomitant high-dose steroids does not hasten recovery in moderate COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial. Infect Dis (Lond). 2023 Dec;55(12):857-873. doi: 10.1080/23744235.2023.2254380. Epub 2023 Oct 6.

Drugs

Indications