A Phase II/III Study of Sargramostim

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: Randomized, Placebo control, Double blind comparative study CONDITION: Coronavirus disease‐2019 (COVID‐19) ; Coronavirus PRIMARY OUTCOME: Number of days to achieve at least 2‐rank improvement on a 7‐point ordinal scale from baseline until Day 28 SECONDARY OUTCOME: (1) Changes in alveolar‐arterial oxygen partial pressure gradient (A‐aDO) on Day 5 and Day 10 from baseline.; (2) Number of days until discharge from baseline (days of shifting to Category 7 on a 7‐point ordinal scale).; (3) Proportion of subjects whose category has shifted to Category 1 or 2 on a 7‐point ordinal scale from baseline until Day 28. INCLUSION CRITERIA: (1) Hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2] positive by polymerase chain reaction (PCR) test. (2) Patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation [SpO2] of 93% or less on breathing of room air at bed rest. (3) Patients for whom written informed consent has been obtained from those themselves or the legally acceptable representatives. (4) Patients aged 20 years or older and younger than 80 years at the time of obtaining informed consent.
Epistemonikos ID: 1bcf697f2e3cb5cde87d3cb93bc12f30d2749282
First added on: Aug 24, 2024