TABLE 3.
Status of inflammatory cytokines and chemokines in serum and RNA levels of inflammatory markers in whole blood determined by qRT-PCR and linear regression analyses on change from baseline scores in adults recently diagnosed with COVID-19 in the LEV and CON groups (n = 30/group)1
| Change in outcome measures associated with LEV treatment2 | ||||
|---|---|---|---|---|
| Measure: treatment | Baseline | Week 4 | Estimate (95% CI) | P value |
| GM-CSF, pg/mL | −0.12 (–0.51, 0.27) | 0.55 | ||
| CON | 17.7 ± 39.5 | 29.18 ± 51.9 | ||
| LEV | 11.4 ± 21.8 | 17.72 ± 35.3 | ||
| IFN-γ, pg/mL | −0.15 (–0.40, 0.10) | 0.24 | ||
| CON | 2.98 ± 3.34 | 3.92 ± 4.33 | ||
| LEV | 3.27 ± 4.00 | 3.43 ± 3.84 | ||
| IL-1β, pg/mL | −22.9 (−42.4, −3.40) | 0.0222 | ||
| CON | 51.5 ± 98.2 | 59.42 ± 105.5 | ||
| LEV | 46.4 ± 76.8 | 35.08 ± 50.4 | ||
| IL-1Ra, pg/mL | −0.12 (–0.30, 0.05) | 0.16 | ||
| CON | 20.0 ± 30.6 | 15.88 ± 22.3 | ||
| LEV | 13.7 ± 13.9 | 9.88 ± 8.64 | ||
| IL-2, pg/mL | −1.73 (−3.45, –0.065) | 0.0492 | ||
| CON | 2.04 ± 4.05 | 2.62 ± 4.57 | ||
| LEV | 2.98 ± 6.37 | 2.21 ± 3.73 | ||
| IL-4, pg/mL | −0.13 (–0.78, 0.52) | 0.69 | ||
| CON | 1.52 ± 2.20 | 2.03 ± 2.85 | ||
| LEV | 0.90 ± 0.82 | 1.17 ± 1.21 | ||
| IL-5, pg/mL | 0.05 (–0.10, 0.21) | 0.50 | ||
| CON | 4.01 ± 3.28 | 4.60 ± 4.05 | ||
| LEV | 3.72 ± 2.74 | 4.87 ± 3.55 | ||
| IL-8, pg/mL | 0.01 (–0.12, 0.15) | 0.86 | ||
| CON | 7.48 ± 3.46 | 6.72 ± 3.42 | ||
| LEV | 7.83 ± 5.49 | 7.57 ± 4.51 | ||
| IL-10, pg/mL | −0.03 (–0.56, 0.51) | 0.92 | ||
| CON | 2.02 ± 5.39 | 2.55 ± 5.10 | ||
| LEV | 2.03 ± 7.47 | 1.12 ± 1.72 | ||
| IL-12p40, pg/mL | −0.07 (–0.21, 0.07) | 0.31 | ||
| CON | 112 ± 74.9 | 126 ± 85.6 | ||
| LEV | 136 ± 152 | 129 ± 103 | ||
| IL-12p70, pg/mL | −0.11 (–0.62, 0.41) | 0.68 | ||
| CON | 11.7 ± 16.6 | 13.9 ± 16.6 | ||
| LEV | 8.7 ± 12.0 | 12.3 ± 17.1 | ||
| IL-13, pg/mL | −0.06 (–0.33, 0.21) | 0.65 | ||
| CON | 71.0 ± 71.8 | 84.0 ± 86.6 | ||
| LEV | 55.3 ± 42.2 | 67.2 ± 55.9 | ||
| MCP-1, pg/mL | 0.04 (–0.08, 0.16) | 0.54 | ||
| CON | 313 ± 104 | 258 ± 115 | ||
| LEV | 354 ± 132 | 316 ± 144 | ||
| TNF-α, pg/mL | −0.98 (−18.6, 16.6) | 0.91 | ||
| CON | 59.8 ± 38.5 | 59.9 ± 49.20 | ||
| LEV | 49.7 ± 23.7 | 52.6 ± 34.03 | ||
| RNA level | ||||
| NF-κB | −0.04 (–0.35, 0.28) | 0.82 | ||
| CON | 10.4 ± 0.92 | 10.4 ± 0.72 | ||
| LEV | 10.3 ± 0.92 | 10.3 ± 0.81 | ||
| IL-6 | −0.07 (–0.31, 0.17) | 0.57 | ||
| CON | 11.8 ± 0.62 | 11.9 ± 0.57 | ||
| LEV | 11.80 ± 0.74 | 11.7 ± 0.80 | ||
| CD177 | −0.10 (–0.88, 0.67) | 0.79 | ||
| CON | 8.26 ± 1.54 | 8.26 ± 1.78 | ||
| LEV | 8.72 ± 1.83 | 8.66 ± 1.74 | ||
Data are presented as mean ± SD. Data were analyzed by multiple linear regression models with the change from baseline as the response variable regressed on the treatment group, adjusting for age, sex, BMI, and existing conditions. CON, placebo; COVID-19, coronavirus disease 2019; GM-CSF, granulocyte-macrophage colony-stimulating factor; LEV, 600 mg Levagen + twice daily; MCP-1, monocyte chemoattractant protein 1.
Data are presented as regression estimate (95% CI) of the estimate for the group assignment variable from each model. Secondary outcome measures were not adjusted for multiplicity.