A Phase II/III Study of Sargramostim

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    60
  • sponsor
    Nobelpharma
Updated on 16 May 2021
Investigator
Masaki Taniguchi
Primary Contact
Japanese Red Cross Society Saitama Red Cross Hospital (9.6 mi away) Contact
+6 other location

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.

Details
Condition *COVID-19, Covid-19
Treatment Placebo, sargramostim
Clinical Study IdentifierNCT04642950
SponsorNobelpharma
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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