TABLE 1.
Baseline demographic, clinical, and laboratory results at randomizationa
| Characteristics | Total (n = 101) | MP (n = 49) | Placebo (n = 52) | P value |
|---|---|---|---|---|
| Age, years, median (IQR) | 60 (49–69) | 60 (46–69) | 60 (50.5–72) | 0.646 |
| BMI, kg/m2, median (IQR) | 28 (25.4–31.0) | 27.8 (24.6–31.1) | 28.4 (25.8–31.0) | 0.409 |
| Sex | ||||
| Female, n/N (%) | 32 (31.7) | 15 (30.6) | 17 (32.7) | 0.822 |
| Male, n/N (%) | 69 (68.3) | 34 (69.4) | 35 (67.3) | |
| Race, n/N (%) | ||||
| White | 9 (8.9) | 3 (6.1) | 6 (11.5) | 0.195 |
| Mixed race (Brown) | 80 (79.2) | 43 (87.8) | 37 (71.2) | |
| Black | 6 (5.9) | 1 (2.0) | 5 (9.6) | |
| Amerindian/Indigenous | 6 (5.9) | 2 (4.1) | 4 (7.7) | |
| Days from illness onset to randomization, median (IQR) | 11.5 (8–15) | 12 (8–15) | 11 (8–14) | 0.416 |
| Pre-existing morbidities, n/N (%) | 92/101 (91.1) | 46/49 (93.9) | 46/52 (88.5) | 0.340 |
| Hypertension | 55/92 (59.8) | 26/46 (56.52) | 29/46 (63.0) | 0.524 |
| Obesity | 34/92 (37.0) | 16/46 (34.8) | 18/46 (39.1) | 0.666 |
| Diabetes | 27/92 (29.4) | 11/46 (23.9) | 16/46 (34.8) | 0.252 |
| Alcohol use | 19/92 (20.7) | 12/46 (26.1) | 7/46 (15.2) | 0.344 |
| Liver disease | 10/92 (10.9) | 2/46 (4.4) | 8/46 (17.4) | 0.074 |
| Smoking (currently) | 4/92 (4.4) | 3/46 (6.5) | 1/46 (2.2) | 0.753 |
| Coronary heart disease | 9/92 (9.8) | 4/46 (8.9) | 5/46 (10.9) | 0.726 |
| Chronic respiratory disease | 4/92 (4.4) | 2/46 (4.4) | 2/46 (4.4) | >0.999 |
| Previous TB | 3/92 (3.3) | 2/46 (4.4) | 1/46 (2.2) | 0.502 |
| TB in treatment | 1/92 (1.1) | 1/46 (2.2) | 0/46 (0) | >0.999 |
| Chronic hematological disease | 2/92 (2.2) | 2/46 (4.4) | 0/46 (0) | 0.495 |
| Neurological disease | 2/92 (2.2) | 1/46 (2.2) | 1/46 (2.2) | >0.999 |
| Medication use, n/N (%) | 101/101 (100) | 49/49 (100) | 52/52 (100) | >0.999 |
| Antibiotics | 76/101 (75.3) | 38/49 (77.6) | 38/52 (73.1) | 0.603 |
| Azithromycin | 57/73 (78.1) | 27/37 (73.0) | 30/36 (83.3) | 0.285 |
| ACE inhibitors | 48/101 (47.5) | 19/49 (38.8) | 29/52 (55.8) | 0.087 |
| Bronchodilators | 10/101 (9.9) | 4/49 (8.2) | 6/52 (11.5) | 0.570 |
| Statins | 5/101 (5.0) | 2/49 (4.1) | 3/52 (5.8) | >0.999 |
| Calcium blockers | 3/101 (3.0) | 3/49 (6.1) | 0/52 (0) | 0.111 |
| Other remedies | 99/101 (98.0) | 47/49 (95.9) | 52/52 (100) | 0.141 |
a
BMI, body mass index; IQR, interquartile range; MP, methylprednisolone; N, sample size number; TB, tuberculosis.