A Phase II/III Study of Sargramostim

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Sargramostim

• Registration Number: NCT04642950
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-24
• Study Start: 2020-12-17
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2021-11
• Results First Submitted: 2023-04-24
• Results First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Results First Posted: 2024-07-19
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NP-26 Placebo	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.
NPC-26	Sargramostim	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).
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

Trial Locations

Locations (7)

Mishuku Hospital; 🇯🇵 Meguro-ku, Tokyo, Japan

Kanagawa Cardiovascular and Respiratory Center; 🇯🇵 Yokohama City, Kanagawa, Japan

Center Hospital of the National Center for Global Health and Medicine; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

IUHW Narita Hospital; 🇯🇵 Narita City, Chiba, Japan

Japanese Red Cross Society Saitama Red Cross Hospital; 🇯🇵 Saitama City, Saitama, Japan

St. Luke's International Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

Japanese Red Cross Medical Center; 🇯🇵 Shibuya-ku, Tokyo, Japan