A Phase II/III Study of Sargramostim

JRCT ID: jRCT2031200180

Registered date:04/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronavirus disease-2019 (COVID-19)
• Date of first enrollment: 08/02/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Randomized, Placebo control, Double blind comparative study

Outcome(s)

• 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 from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration
(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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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 85 years at the time of obtaining informed consent.

Exclude criteria

(1) Patients who have been participating in other intervention studies, such as studies on unapproved pharmacotherapy, within 90 days prior to screening.
(2) Patients who have experienced off-label use of approved drugs (including those for COVID-19 treatment other than steroids as standard treatment) within 7 days prior to screening.
(3) Patients who are not expected to survive longer than 24 hours after commencement of study drug administration.
(4) Patients who are using invasive ventilator or extracorporeal membrane oxygenation (ECMO).
(5) Patients who have a chronic respiratory disease requiring continuous home oxygen therapy or ventilator use.
(6) Patients with an underlying condition that is considered very unlikely to withdraw ventilator (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial pulmonary fibrosis).
(7)Patients who have a disease including bronchial asthma, lower respiratory tract infections, and interstitial lung diseases that may affect the assessment of the clinical study, since before the symptom onset of COVID-19.
(8) Patients who have a disease including leukemia and leukocytosis that causes leukocytosis.
(9) Patients who have a chronic kidney disease requiring dialysis.
(10) Patients who have severe liver failure (Child Pugh grade C).
(11) Patients aged 80 years or older with any of heart failure, cerebrovascular disease, obesity (BMI 30 or higher), dyslipidemia, hypertension or diabetes.

Related Information

• Primary Sponsor: Taniguchi Masaki