Covid19 Clinical Trial
— SCOPEOfficial title:
A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19
Verified date | December 2022 |
Source | Partner Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Partner Therapeutics, Inc. | United States Department of Defense |
United States, Argentina,
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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