TABLE I.
Patient Baselinea Characteristics and Other Treatments During Study
| Characteristics | Sargramostim arm (n = 78) | SOC arm (n = 44) | Total (N = 122) |
|---|---|---|---|
| Age at randomization, mean (SD), years | 61.7 (13.0) | 58.2 (10.6) | 60.4 (12.3) |
| Age ≥65 years, n (%) | 31 (39.7) | 14 (31.8) | 45 (36.9) |
| Sex, M, n (%) | 35 (44.9) | 26 (59.1) | 61 (50.0) |
| Race, n (%) | |||
| American Indian or Alaska Native | 2 (2.6) | 0 | 2 (1.6) |
| Asian | 2 (2.6) | 0 | 2 (1.6) |
| Black or African-American | 6 (7.7) | 1 (2.3) | 7 (5.7) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (2.3) | 1 (0.8) |
| White | 48 (61.5) | 33 (75.0) | 81 (66.4) |
| Others | 20 (25.6) | 9 (20.5) | 29 (23.8) |
| Ethnicity, n (%) | |||
| Hispanic/Latino | 24 (30.8) | 11 (25.0) | 35 (28.7) |
| Patients assessed for BMI at baseline, n | 73 | 43 | 116 |
| BMI, mean (SD), kg/m2 | 34.9 (9.0) | 35.4 (9.6) | 35.1 (9.2) |
| Obesity (BMI ≥30), n (%) | 49 (67.1) | 31 (72.1) | 80 (69.0) |
| Baseline comorbidity (reported medical history) | |||
| Hypertension, n (%) | 53 (67.9) | 29 (65.9) | 82 (67.2) |
| Disorders related to glucose metabolism (diabetes mellitus, hyperglycemia, impaired glucose tolerance), n (%) | 47 (60.3) | 19 (43.2) | 66 (62.3) |
| Diabetes mellitusb | 36 (46.2) | 15 (34.1) | 51 (41.8) |
| Disorders related to lipid metabolism | 36 (46.2) | 14 (31.8) | 50 (41.0) |
| Hyperlipidemia, n (%) | 33 (42.3) | 13 (29.5) | 46 (37.7) |
| Dyslipidemia, n (%) | 3 (3.8) | 1 (2.3) | 4 (3.3) |
| Respiratory, thoracic, and mediastinal disorders, n (%) | 52 (66.7) | 19 (43.2) | 71 (58.2) |
| Asthma | 16 (20.5) | 5 (11.4) | 21 (17.2) |
| Respiratory failurec | 19 (24.4) | 9 (20.5) | 28 (23.0) |
| Sleep apnea syndrome | 15 (19.2) | 5 (11.4) | 20 (16.4) |
| Baseline SOFA score, mean (SD) | 2.3 (0.6) | 2.4 (1.0) | 2.4 (0.8) |
| Baseline ordinal score, n (%)d | |||
| 4 | 40 (51.3) | 22 (50.0) | 62 (50.8) |
| 5 | 38 (48.7) | 22 (50.0) | 60 (49.2) |
| Baseline oxygenation, n | 71 | 41 | 112 |
| PaO2/FiO2 ratio, mean (SD) | 146.8 (79.3) | 132.8 (61.1) | 141.7 (73.2) |
| P(A–a)O2, mean (SD), mmHg | 293.8 (181.5) | 322.1 (175.1) | 304.2 (178.9) |
| Other COVID-directed treatments at any time during the studye | |||
| Systemic corticosteroid, n (%) | 72 (92.3) | 43 (97.7) | 115 (94.3) |
| Remdesivir, n (%) | 59 (75.6) | 36 (81.8) | 95 (77.9) |
| Convalescent plasma, n (%) | 13 (16.7) | 10 (22.7) | 23 (18.9) |
| Baricitinib | 2 (2.6) | 2 (4.5) | 4 (3.3) |
| Tocilizumab | 2 (2.6) | 1 (2.3) | 3 (2.5) |
| Hydroxychloroquine | 0 | 1 (2.3) | 1 (0.8) |
Abbreviations: BMI = body mass index; FiO2 = fraction of inspired oxygen; M = male; PaO2 = partial pressure of oxygen; P(A–a)O2 = alveolar–arterial oxygen gradient; SOC = standard of care; SOFA = sequential organ failure assessment.
Baseline is defined as the last assessment before administration of study drug for sargramostim, or up to and including the randomization date for the SOC arm.
“Diabetes mellitus” includes preferred terms “Diabetes mellitus,” “Type 1 diabetes mellitus,” “Type 2 diabetes mellitus,” “Insulin-requiring type 2 diabetes mellitus,” and “Diabetic complication/type 2 diabetes mellitus with complications.”
“Respiratory failure” includes preferred terms “Respiratory failure,” “Acute respiratory failure,” and “Chronic respiratory failure.”
Ordinal scores are based on a 9-point scoring system, ranging from 0 (no hospitalization) to 8 (death), where 4 is defined as “Hospitalized, requiring supplemental oxygen by mask or nasal prongs” and 5 is defined as “Hospitalized, requiring high-flow oxygen therapy, noninvasive mechanical ventilation, or both” (additional details on the ordinal scale in Supplementary Methods). Of note, noninvasive ventilation (CPAP, BiPAP, for hypoxemia) was an exclusion criterion for this study.
Institutional SOC before and during the study was not limited and may have included antibiotics, antivirals, corticosteroids, and convalescent plasma. Other drugs/classes received by >5% of patients included azithromycin (11.5%) and doxycycline (13.1%). One patient on the sargramostim arm received a COVID-19 vaccine. One patient on the SOC arm received hydroxychloroquine.