A Phase II/III Study of Sargramostim

NCT04642950 | Completed Phase 2 Results

• 1 other identifier: NPC-26-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  Period until Day 28 (including the case after discharge).

Secondary Outcomes (3)

• Changes From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO)

  Period until Day 28 (including the case after discharge).

• Number of Days Until Discharge From Baseline

  Period until Day 28 (including the case after discharge).

• Proportion of Subjects Whose Category Has Shifted to Category 1 or 2

  Period until Day 28 (including the case after discharge).

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Sargramostim DRUG

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.

Also known as: Leukine

NPC-26

Placebo DRUG

2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.

NP-26 Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (7)

IUHW Narita Hospital

Narita, Chiba, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Location

Japanese Red Cross Society Saitama Red Cross Hospital

Saitama, Saitama, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

Location

Mishuku Hospital

Meguro-ku, Tokyo, Japan

Location

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 37729076 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Information Desk
• Organization: Nobel Pharma Co. Ltd.

taniguchi.masaki@nobelpharma.co.jp

+81-3-6670-3800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 24, 2020
• Study Start: December 17, 2020
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)