Covid19Phase 2SCOPENCT04707664
Sargramostim Use in COVID-19 to Recover Patient Health
A Phase 2 study testing Sargramostim in people with Covid19 and SARS-CoV Infection, run by Partner Therapeutics, Inc. at 37 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Sargramostim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 27 Apr 2021to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 days prior to randomization:
- Fever or chills
- New onset or worsening cough
- Sore throat
- Malaise or fatigue
Show all 26Show fewer
- Headache
- Muscle pain (myalgias) or body aches
- Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
- New onset or worsening shortness of breath or difficulty breathing
- Nasal congestion or runny nose
- 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.
- At higher risk for progression to more severe COVID-19
- Age ≥ 60 years
- 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
- 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
- Negative pregnancy test (if woman of childbearing potential)
- Females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to Day 28
- The patient (or legally authorized decision maker) must give informed consent
Who cannot join
- Hospitalized patients
- 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
- Patients enrolled in interventional clinical trials for other experimental therapies
- Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions
- Patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma)
- Patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung transplant, or cystic fibrosis
Show all 11Show fewer
- 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
- Patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product
- Patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product
- Pregnant or breastfeeding females
- 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
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States34 sites
Synergy Healthcare
Bradenton, Florida, 34208
Gwinnett Research Institute, LLC
Buford, Georgia, 30519
Hope Clinical Research
Canoga Park, California, 91303
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215
Paramount Research Solutions
College Park, Georgia, 30349
Benchmark Research
Colton, California, 92324
Hometown Urgent Care and Research
Columbus, Ohio, 43214
UCCT @ City Doc Urgent Care-McKinney
Dallas, Texas, 75204
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Research
Dayton, Ohio, 45424
TruCare Internal Medicine and Infectious Disease
DuBois, Pennsylvania, 15801
Urgent Care Clinical Trials @ AFC Urgent Care - Easley
Easley, South Carolina, 29640
Invesclinic US LLC
Edinburg, Texas, 78539
Revive Research Institute, Inc.
Farmington Hills, Michigan, 48334
Invesclinic US, LLC.
Fort Lauderdale, Florida, 33308
Indago Research & Health Center, Inc. (Subject Visits Only)
Hialeah, Florida, 33012
Encore Medical Research
Hollywood, Florida, 33021
Dorrington Medical Associates
Houston, Texas, 77030
Encore Imaging & Medical Research
Houston, Texas, 77065
Excel Clinical Research
Las Vegas, Nevada, 89109
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
SMS Clinical Research, LLC
Mesquite, Texas, 75149
Monroe Biomedical Research
Monroe, North Carolina, 28112
Great Plains Health
North Platte, Nebraska, 69101
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
IMIC Inc.
Palmetto Bay, Florida, 33157
Novotrial Research Group
Pearland, Texas, 77584
West Valley Research Clinic, LLC
Phoenix, Arizona, 85031
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
University of Utah Health
Salt Lake City, Utah, 84108
Sun Research Institute
San Antonio, Texas, 78215
Richmond University Medical Center
Staten Island, New York, 10310
Revival Research Institute, LLC.
Sterling Heights, Michigan, 48312
Encore Medical Research of Weston
Weston, Florida, 33331
Argentina3 sites
Sanatorio Santa Barbara
Buenos Aires, C1414DTK
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
About this study
Official title: A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19
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.
Read the detailed 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.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Sargramostim, Placebo
- Keywords
- COVID-19, SARS-CoV2, sargramostim, Leukine, (recombinant human) GM-CSF, immune modulator, SCOPE
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SargramostimDrug
Also called Leukine, GM-CSF
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sargramostim Arm | Experimental | Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Receives: Drug: Sargramostim |
| Placebo Arm | Placebo comparator | Day 1 - 5: Placebo treatment in addition to standard of care for COVID-19 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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.
Measured: Day 28 and Day 60
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.
Measured: Day 28 and Day 60
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.
Measured: Day 7, 14, and 28
Number of Participants With Adverse Events
Adverse events up to Day 60
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start27 Apr 2021
- Primary completion28 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Partner Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Fiona Garner, PhD, Study director, Partner Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707664
- Sponsor's protocol ID
- PTX-001-003
- Acronym
- SCOPE
- Status last verified
- Dec 2022
- First submitted
- 11 Jan 2021
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19
- ClinicalTrials.gov ID
- NCT04707664
- Acronym / sponsor ID
- SCOPE / PTX-001-003
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- COVID-19, SARS-CoV2, sargramostim, Leukine, (recombinant human) GM-CSF, immune modulator, SCOPE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Partner Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Sargramostim Arm | Experimental | Drug: SargramostimDay 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 |
| Placebo Arm | Placebo comparator | Drug: PlaceboDay 1 - 5: Placebo treatment in addition to standard of care for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
- Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 days prior to randomization:
- At higher risk for progression to more severe COVID-19
- 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
- Negative pregnancy test (if woman of childbearing potential)
Key exclusion criteria (11 listed)
- Hospitalized patients
- 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
- Patients enrolled in interventional clinical trials for other experimental therapies
- Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions
- Patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SargramostimAlso: Leukine, GM-CSFAll 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. | Drug | Sargramostim Arm |
| PlaceboAll 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. | Drug | Placebo Arm |
Primary outcome
Number of Participants With an Emergency Room Visit or Hospitalization, or Death by Day 28
Time frame: 28 days
Percentage of patients who experience any emergency room visit or hospitalization, or death
4 secondary outcomes
Disease Progression Based on NIAID Score
Time frame: Day 28 and Day 60
Time to Disease Progression Based on NIAID Score
Time frame: Day 28 and Day 60
Change From Baseline in Overall Symptom Scores
Time frame: Day 7, 14, and 28
Number of Participants With Adverse Events
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Garner, PhD study director
Partner Therapeutics, Inc.
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sargramostim in people with Covid19 and SARS-CoV Infection, run by Partner Therapeutics, Inc. at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Emergency Room Visit or Hospitalization, or Death by Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.