A Phase II/III Study of Sargramostim

Sponsor
Nobelpharma (Industry)
Overall Status
Completed
CT.gov ID
NCT04642950
Collaborator
(none)
70
7
2
10.3
10
1

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

Study Type:
Interventional
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 :
Dec 17, 2020
Actual Primary Completion Date :
Oct 25, 2021
Actual Study Completion Date :
Oct 25, 2021

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:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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).

    3. 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

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.
    Responsible Party:
    Nobelpharma
    ClinicalTrials.gov Identifier:
    NCT04642950
    Other Study ID Numbers:
    • NPC-26-1
    First Posted:
    Nov 24, 2020
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021