COVID-19Phase 2/3NCT04642950
A Phase II/III Study of Sargramostim
A Phase 2/3 study testing Sargramostim in people with COVID-19, run by Nobelpharma at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Sargramostim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 7 sitesJapan
- Study dates
- 17 Dec 2020to 25 Oct 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
St. Luke's International Hospital
Chuo-ku, Tokyo
Mishuku Hospital
Meguro-ku, Tokyo
IUHW Narita Hospital
Narita, Chiba
Japanese Red Cross Society Saitama Red Cross Hospital
Saitama, Saitama
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa
About this study
Official title: A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
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.
- Conditions
- COVID-19
- Being tested
- Sargramostim, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SargramostimDrug
Also called Leukine
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.
PlaceboDrug
2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| NPC-26 | Experimental | 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. Receives: Drug: Sargramostim |
| NP-26 Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Period until Day 28 (including the case after discharge).
Secondary outcomes (3)
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.
Measured: Period until Day 28 (including the case after discharge).
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).
Measured: Period until Day 28 (including the case after discharge).
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
Measured: Period until Day 28 (including the case after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start17 Dec 2020
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642950
- Sponsor's protocol ID
- NPC-26-1
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2020
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37729076
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04642950
- Acronym / sponsor ID
- NPC-26-1
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPC-26 | Experimental | Drug: SargramostimSargramostim (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. |
| NP-26 Placebo | Placebo comparator | Drug: PlaceboPhysiological 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SargramostimAlso: Leukine250 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. | Drug | NPC-26 |
| Placebo2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes. | Drug | NP-26 Placebo |
Primary outcome
2-rank Improvement on a 7-point Ordinal Scale
Time frame: 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.
3 secondary outcomes
Changes From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO)
Time frame: Period until Day 28 (including the case after discharge).
Number of Days Until Discharge From Baseline
Time frame: Period until Day 28 (including the case after discharge).
Proportion of Subjects Whose Category Has Shifted to Category 1 or 2
Time frame: Period until Day 28 (including the case after discharge).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37729076Shimasaki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sargramostim in people with COVID-19, run by Nobelpharma at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-rank Improvement on a 7-point Ordinal Scale (time frame: Period until Day 28 (including the case after discharge).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.