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Trial record 1 of 2 for:    sargramostim | covid-19 | Japan
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A Phase II/III Study of Sargramostim

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642950
Recruitment Status : Completed
First Posted : November 24, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

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
COVID-19 Drug: Sargramostim Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
Actual Study Start Date : December 17, 2020
Actual Primary Completion Date : October 25, 2021
Actual Study Completion Date : October 25, 2021

Resource links provided by the National Library of Medicine


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 Name: Leukine

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) [ Time Frame: 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.

  2. Number of days until discharge from baseline [ Time Frame: 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).

  3. Proportion of subjects whose category has shifted to Category 1 or 2 [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Japanese male or female subjects who have been confirmed to meet all the following 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.

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.

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642950


Locations
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Japan
IUHW Narita Hospital
Narita City, Chiba, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama City, Kanagawa, Japan
Japanese Red Cross Society Saitama Red Cross Hospital
Saitama City, Saitama, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
Mishuku Hospital
Meguro-ku, Tokyo, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, Japan
Sponsors and Collaborators
Nobelpharma
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Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT04642950    
Other Study ID Numbers: NPC-26-1
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Sargramostim
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs