Back to resultsA Phase II/III Study of Sargramostim
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Sargramostim
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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.
Sites / Locations
- IUHW Narita Hospital
- Kanagawa Cardiovascular and Respiratory Center
- Japanese Red Cross Society Saitama Red Cross Hospital
- St. Luke's International Hospital
- Mishuku Hospital
- Japanese Red Cross Medical Center
- Center Hospital of the National Center for Global Health and Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NPC-26
NP-26 Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
2-rank improvement on a 7-point ordinal scale
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)
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
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
Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04642950
Brief Title
A Phase II/III Study of Sargramostim
Official Title
A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-26
Arm Type
Experimental
Arm Description
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.
Arm Title
NP-26 Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sargramostim
Other Intervention Name(s)
Leukine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
Primary Outcome Measure Information:
Title
2-rank improvement on a 7-point ordinal scale
Description
Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
Time Frame
Period until Day 28 (including the case after discharge).
Secondary Outcome Measure Information:
Title
Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO)
Description
Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration.
Time Frame
Period until Day 28 (including the case after discharge).
Title
Number of days until discharge from baseline
Description
Number of days until discharge from baseline (days of shifting to Category 7 on a 7-point ordinal scale).
Time Frame
Period until Day 28 (including the case after discharge).
Title
Proportion of subjects whose category has shifted to Category 1 or 2
Description
Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28
Time Frame
Period until Day 28 (including the case after discharge).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
IUHW Narita Hospital
City
Narita City
State/Province
Chiba
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama City
State/Province
Kanagawa
Country
Japan
Facility Name
Japanese Red Cross Society Saitama Red Cross Hospital
City
Saitama City
State/Province
Saitama
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Mishuku Hospital
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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A Phase II/III Study of Sargramostim
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