A Phase II/III Study of Sargramostim

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642950
• Other study ID #: NPC-26-1
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 17, 2020
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2021
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Mishuku Hospital	Meguro-ku	Tokyo
Japan	IUHW Narita Hospital	Narita City	Chiba
Japan	Japanese Red Cross Society Saitama Red Cross Hospital	Saitama City	Saitama
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	Kanagawa Cardiovascular and Respiratory Center	Yokohama City	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO)	Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration.	Period until Day 28 (including the case after discharge).
Secondary	Number of days until discharge from baseline	Number of days until discharge from baseline (days of shifting to Category 7 on a 7-point ordinal scale).	Period until Day 28 (including the case after discharge).
Secondary	Proportion of subjects whose category has shifted to Category 1 or 2	Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28	Period until Day 28 (including the case after discharge).