Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.

Mean Change in 6-point Ordinal Scale for Clinical Improvement

description: The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal Membrane Oxygenation) ; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome
time_frame: at Baseline, at Day 6

Number of Days in Hospital

time_frame: through study completion, an average of 5 months

Number of Participants With Nosocomial Infection no./Total no (%)

time_frame: during hospital admission (up to 28 days)

Death

time_frame: at 28 days

Number of Participants Progressed to Mechanical Ventilation and/or ARDS

time_frame: during hospital admission (up to 28 days)

Time to Clinical Sign Score < 6 for at Least 24h

description: Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = <37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = >39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome
time_frame: During hospital admission (up to 28 days)

Change in Clinical Sign Score

description: Clinical Sign score (0-18) by scoring 6 clinical signs from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe): Fever (0 = <37°C; 1 = 37.1-38°C; 2 = 38.1-39°C; 3 = >39°C) last 24h; Cough; Fatigue; Shortness of breath; Diarrhea; Body pain. Higher values represent a worse outcome.
time_frame: at baseline, at day 6

Change in (National Early Warning Score2) NEWS2 Score

description: The NEWS2 score standardises the assessment and response to acute illness. Six physiological parameters form the basis of the scoring system:
respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk
time_frame: at baseline, at day 6

Change in Sequential Organ Failure Assessment (SOFA Score)

description: The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). Score ranges from 0 (best) to 24 (worst) points.
time_frame: at baseline, at day 6

Change in Ferritin Level

time_frame: at baseline, at day 6

Change in D-dimer Level

time_frame: at baseline, at day 6

Change in CRP Level

time_frame: at baseline, at day 6

Change in Lymphocyte Count

time_frame: at baseline, at day 6

Change in Eosinophil Count

time_frame: at baseline, at day 6

HRCT (High-Resolution Computed Tomography) Fibrosis Score

description: The HRCT fibrosis score is a subjective assessment of the overall extent of normal attenuation, reticular abnormalities, honeycombing and traction bronchiectasis . The HRCT findings are graded on a scale of 1-4 based on the classification system: 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing. The presence of each of the above four HRCT findings is assessed independently in three (upper, middle and lower) zones of each lung. The extent of each HRCT finding was determined by visually estimating the percentage (to the nearest 5%) of parenchymal involvement in each zone. The score for each zone was calculated by multiplying the percentage of the area by the grading scale score (i.e. 1. normal attenuation; 2. reticular abnormality; 3. traction bronchiectasis; and 4. honeycombing). The six zone scores were averaged to determine the total score for each patient. The score ranges from 100 to 400, higher values represent more fibrosis.
time_frame: at follow-up, 10-20 weeks after day 10 or discharge, whichever comes first ^[2]