A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)

Nobelpharma7 sites in 1 country70 target enrollmentDecember 17, 2020

ConditionsCOVID-19

InterventionsSargramostim Placebo

DrugsSargramostim Placebo

Overview

Phase: Phase 2
Intervention: Sargramostim
Conditions: COVID-19
Sponsor: Nobelpharma
Enrollment: 70
Locations: 7
Primary Endpoint: 2-rank Improvement on a 7-point Ordinal Scale
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 17, 2020

End Date

October 25, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nobelpharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

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.
•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-
•Patients who have a disease including leukemia and leukocytosis that causes leukocytosis.
•Patients who have a chronic kidney disease requiring dialysis.

Arms & Interventions

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.

Intervention: Sargramostim

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.

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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).)