A Phase II/III Study of Sargramostim
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NPC-26 Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment. |
Drug: Sargramostim
250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes.
Other Names:
|
Placebo Comparator: NP-26 Placebo Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment. |
Drug: Placebo
2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
|
Outcome Measures
Primary Outcome Measures
- 2-rank improvement on a 7-point ordinal scale [Period until Day 28 (including the case after discharge).]
Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
Secondary Outcome Measures
- Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) [Period until Day 28 (including the case after discharge).]
Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration.
- Number of days until discharge from baseline [Period until Day 28 (including the case after discharge).]
Number of days until discharge from baseline (days of shifting to Category 7 on a 7-point ordinal scale).
- Proportion of subjects whose category has shifted to Category 1 or 2 [Period until Day 28 (including the case after discharge).]
Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28
Eligibility Criteria
Criteria
Inclusion Criteria:
Japanese male or female subjects who have been confirmed to meet all the following criteria.
-
Hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] positive by polymerase chain reaction (PCR) test.
-
Patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation [SpO2] of 93% or less on breathing of room air at bed rest.
-
Patients for whom written informed consent has been obtained from those themselves or the legally acceptable representatives.
-
Patients aged 20 years or older and younger than 85 years at the time of obtaining informed consent.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded. Unless otherwise stated, the following criteria refer to those at the time of screening.
-
Patients who have been participating in other intervention studies, such as studies on unapproved pharmacotherapy, within 90 days prior to screening.
-
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.
-
Patients who are not expected to survive longer than 24 hours after commencement of study drug administration.
-
Patients who are using invasive ventilator or extracorporeal membrane oxygenation (ECMO).
-
Patients who have a chronic respiratory disease requiring continuous home oxygen therapy or ventilator use.
-
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).
-
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.
-
Patients who have a disease including leukemia and leukocytosis that causes leukocytosis.
-
Patients who have a chronic kidney disease requiring dialysis.
-
Patients who have severe liver failure (Child Pugh grade C).
-
Patients aged 80 years or older with any of heart failure, cerebrovascular disease, obesity (BMI 30 or higher), dyslipidemia, hypertension or diabetes.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | IUHW Narita Hospital | Narita City | Chiba | Japan | |
2 | Kanagawa Cardiovascular and Respiratory Center | Yokohama City | Kanagawa | Japan | |
3 | Japanese Red Cross Society Saitama Red Cross Hospital | Saitama City | Saitama | Japan | |
4 | St. Luke's International Hospital | Chuo-ku | Tokyo | Japan | |
5 | Mishuku Hospital | Meguro-ku | Tokyo | Japan | |
6 | Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | Japan | |
7 | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-Ku | Tokyo | Japan |
Sponsors and Collaborators
- Nobelpharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NPC-26-1