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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04707664
Other study ID # PTX-001-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 27, 2021
Est. completion date January 31, 2022

Study information

Verified date December 2022
Source Partner Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death.


Description:

This Phase 2b, multicenter, placebo-controlled, double-blind study will randomize approximately 500 adult patients who are symptomatic with mild or moderate COVID-19 (as defined in the FDA Guidance Document: Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, May 2020) who are at high risk for progression to more severe disease. Patients will be randomized in a 1:1 ratio to inhaled sargramostim plus standard of care (SOC) or placebo plus SOC. Enrollment of patients who have completed a COVID-19 vaccination regimen or participated in a COVID-19 vaccine clinical trial will be capped at approximately 100 patients. All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo diluent. Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer. Patients will be followed for up to 60 days after start of treatment. Sargramostim (Leukine) is a formulation of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), which is a critical cytokine for healthy pulmonary function. Detailed studies have shown that GM-CSF is necessary for alveolar macrophage (AM) maturation and maintenance. Although GM-CSF was discovered as a myelopoietic growth factor, it has diverse additional effects that both promote differentiation of myeloid precursors into neutrophils, monocytes, and dendritic cells and control function of mature myeloid cells. GM-CSF is also known to reverse immunoparalysis seen in sepsis, resulting in beneficial outcomes. In addition, GM-CSF prevents bacteremia in post influenza bacterial pneumonia through locally mediated improved lung antibacterial resistance and increased reactive oxygen species production by AMs. Pulmonary delivery of this GM-CSF has potential to reduce morbidity and mortality due to viral pneumonias, potentially including COVID-19.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date January 31, 2022
Est. primary completion date December 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or a molecular test =5 days prior to randomization. The test should have been authorized by the relevant regulatory authority. 2. Have one or more of the following mild or moderate COVID-19 symptoms for =5 days prior to randomization: 1. Fever or chills 2. New onset or worsening cough 3. Sore throat 4. Malaise or fatigue 5. Headache 6. Muscle pain (myalgias) or body aches 7. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. New onset or worsening shortness of breath or difficulty breathing 9. Nasal congestion or runny nose 10. New loss of taste (ageusia) and/or smell (anosmia). Note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the SOLE qualifying symptoms for enrollment. 3. At higher risk for progression to more severe COVID-19 1. Age = 60 years 2. Age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe COVID-19: - Chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis - Obesity with BMI = 30 kg/m2 - Cardiovascular disease - Sickle cell disease or thalassemia - Diabetes mellitus being managed with concomitant medications - Hypertension being managed with concomitant medications - Chronic kidney disease 4. Oxygen saturation by pulse oximeter > 93% on room air. Note: at altitudes of >4000 feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted 5. Negative pregnancy test (if woman of childbearing potential) 6. Females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to Day 28 7. The patient (or legally authorized decision maker) must give informed consent Exclusion Criteria: 1. Hospitalized patients 2. Patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate COVID-19 in an outpatient setting 3. Patients enrolled in interventional clinical trials for other experimental therapies 4. Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. Patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. Patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung transplant, or cystic fibrosis 7. Patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. Patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. Patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. Pregnant or breastfeeding females 11. Patients who, in the opinion of the Investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sargramostim
All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days.
Placebo
All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days.

Locations

Country Name City State
Argentina Sanatorio Santa Barbara Buenos Aires
Argentina Centro de Investigaciones Medicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto Medico de la Fundacion Estudios Clinicos Rosario Santa Fe
United States Synergy Healthcare Bradenton Florida
United States Gwinnett Research Institute, LLC Buford Georgia
United States Hope Clinical Research Canoga Park California
United States University Diabetes & Endocrine Consultants Chattanooga Tennessee
United States Hometown Urgent Care and Research Cincinnati Ohio
United States Paramount Research Solutions College Park Georgia
United States Benchmark Research Colton California
United States Hometown Urgent Care and Research Columbus Ohio
United States UCCT @ City Doc Urgent Care-McKinney Dallas Texas
United States Urgent Care Specialists, LLC DBA Hometown Urgent Care and Research Dayton Ohio
United States TruCare Internal Medicine and Infectious Disease DuBois Pennsylvania
United States Urgent Care Clinical Trials @ AFC Urgent Care - Easley Easley South Carolina
United States Invesclinic US LLC Edinburg Texas
United States Revive Research Institute, Inc. Farmington Hills Michigan
United States Invesclinic US, LLC. Fort Lauderdale Florida
United States Indago Research & Health Center, Inc. (Subject Visits Only) Hialeah Florida
United States Encore Medical Research Hollywood Florida
United States Dorrington Medical Associates Houston Texas
United States Encore Imaging & Medical Research Houston Texas
United States Excel Clinical Research Las Vegas Nevada
United States Applied Research Center of Arkansas Little Rock Arkansas
United States SMS Clinical Research, LLC Mesquite Texas
United States Monroe Biomedical Research Monroe North Carolina
United States Great Plains Health North Platte Nebraska
United States Olive Branch Family Medical Center Olive Branch Mississippi
United States IMIC Inc. Palmetto Bay Florida
United States Novotrial Research Group Pearland Texas
United States West Valley Research Clinic, LLC Phoenix Arizona
United States TidalHealth Peninsula Regional, Inc. Salisbury Maryland
United States University of Utah Health Salt Lake City Utah
United States Sun Research Institute San Antonio Texas
United States Richmond University Medical Center Staten Island New York
United States Revival Research Institute, LLC. Sterling Heights Michigan
United States Encore Medical Research of Weston Weston Florida

Sponsors (2)

Lead Sponsor Collaborator
Partner Therapeutics, Inc. United States Department of Defense

Countries where clinical trial is conducted

United States,  Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With an Emergency Room Visit or Hospitalization, or Death by Day 28 Percentage of patients who experience any emergency room visit or hospitalization, or death 28 days
Secondary Disease Progression Based on NIAID Score Proportion of patients with any progression of disease as determined by a = 2-point increase from baseline in the National Institute of Allergy and Infectious Disease (NIAID) Ordinal Scale up to Day 28, and Day 60. The NIAID Ordinal Scale is a 1-8 scale and is an assessment of clinical status on a given study day. A score of 1 indicates the patient is not hospitalized and has no limitations on activities. A score of 8 indicates the patient has died. Day 28 and Day 60
Secondary Time to Disease Progression Based on NIAID Score Time to progression of disease as determined by a = 2-point increase in the NIAID ordinal scale up to Day 28, and Day 60. The NIAID ordinal scale is a 1-8 scale and is an assessment of clinical status on a given study day. A score of 1 indicates the patient is not hospitalized and has no limitations on activities. A score of 8 indicates the patient has died. Day 28 and Day 60
Secondary Change From Baseline in Overall Symptom Scores Change from baseline in overall symptom score as measured by the Symptom Score Questionnaire on Day 7, Day 14 and Day 28. The overall symptom score is the sum of 14 individual symptom scores from Symptom Score Questionnaire. Individual symptom scores correspond to the following responses: None = 0, Mild = 1, Moderate = 2, Severe = 3; None = 0, 1-2 times = 1, 3-4 times = 2, 5 or more times = 3; Same as usual = 0, Less than usual = 1, No sense = 2. The lowest score could be 0, and the highest score could be 42. Patients with higher scores have more severe symptoms from COVID-19. Day 7, 14, and 28
Secondary Number of Participants With Adverse Events Adverse events up to Day 60 60 days
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