Study of Sargramostim in Patients With COVID-19
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Sargramostim; Standard of care
Intervention description: Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.; Standard of care for COVID-19
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This Phase 2, randomized, open-label study will enroll approximately 120 patients with COVID-19 associated acute hypoxemia. It is a randomized 2:1 study to evaluate sargramostim treatment plus institutional standard of care compared to institutional standard of care alone.
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; sargramostim; Leukine; rhu-GM-CSF; acute hypoxemia; iLeukPulm; SARS-CoV-2

Summary:

      The purpose of this research is to find out if a drug (sargramostim) also known as Leukine®
      could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from
      the effects of COVID-19, and this research study will help to find this out.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged ≥ 18 years

          -  Patients (or legally authorized decision maker) must provide informed consent

          -  Test positive for SARS-CoV-2 virus by PCR

          -  Admitted to hospital

          -  Presence of acute hypoxemia defined as (either or both)

               -  saturation below 93% on ≥ 2 L/min oxygen supplementation

               -  PaO2/FiO2 below 350

        Exclusion Criteria:

          -  Patients requiring invasive (mechanical ventilation) or non-invasive (CPAP, BiPAP for
             hypoxemia) ventilation or ECMO (Note: oxygen supplementation using high flow oxygen
             systems or low flow oxygen systems would not exclude patients from this study)

          -  Intractable metabolic acidosis

          -  Cardiogenic pulmonary edema

          -  Hypotension requiring use of vasopressors

          -  Hyperferritinemia (serum ferritin ≥2,000 mcg/L)

          -  White blood cell count > 50,000/mm3

          -  Participation in another interventional clinical trial for COVID-19 therapy

          -  Highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24
             hours prior to first dose of sargramostim

          -  Known or suspected intolerance or hypersensitivity to sargramostim, or any component
             of the product

          -  Previous experience of severe and unexplained side effects during aerosol delivery of
             any kind of medical product

          -  Presence of any preexisting illness that, in the opinion of the Investigator, would
             place the patient at an unreasonably increased risk through participation in this
             study

          -  Pregnant or breastfeeding females

          -  Severe or uncontrolled pulmonary comorbid conditions, including systemic steroid
             dependent asthma, systemic steroid dependent COPD, oxygen dependent COPD, lung
             transplant, known interstitial lung disease, or cystic fibrosis