Table 1.
Characteristics of the Patients at Baseline (Modified Intention-to-Treat Population).*
| Characteristic | Metformin | Ivermectin | Fluvoxamine† | |||
|---|---|---|---|---|---|---|
| Active (N = 663) | Control (N = 660) | Active (N = 410) | Control (N = 398) | Active (N = 334) | Control (N = 327) | |
| Demographic | ||||||
| Median age (IQR) —yr | 46 (38–55) | 45 (37–55) | 46 (39–55) | 45 (37–56) | 46 (38–53) | 43 (37–53) |
| Female sex — no. (%)† | 359 (54.1) | 382 (57.9) | 216 (52.7) | 226 (56.8) | 170 (50.9) | 188 (57.5) |
| Race or ethnic group‡ | ||||||
| Native American | 10 (1.5) | 17(2.6) | 7 (1.7) | 9 (2.3) | 8 (2.4) | 9 (2.8) |
| Asian | 25 (3.8) | 26 (3.9) | 19 (4.6) | 18 (4.5) | 9 (2.7) | 12 (3.7) |
| Hawaiian or Pacific Islander | 5 (0.8) | 4 (0.6) | 2 (0.5) | 3 (0.8) | 2 (0.6) | 3 (0.9) |
| Black | 55 (8.3) | 45 (6.8) | 30 (7.3) | 29 (7.3) | 28 (8.4) | 23 (7.0) |
| White | 545 (82.2) | 546 (82.7) | 340 (82.9) | 322 (80.9) | 272 (81.4) | 267 (81.7) |
| Other | 43 (6.5) | 37 (5.6) | 24 (5.9) | 29 (7.3) | 21 (6.3) | 23 (7.0) |
| Latinx | 76 (11.5) | 84 (12.7) | 41 (10.0) | 57(14.3) | 42 (12.6) | 46 (14.1) |
| Medical history | ||||||
| Body-mass index | ||||||
| Median (IQR) | 30 (27–34) | 30 (27–34) | 30 (27–34) | 30 (27–34) | 29 (27–34) | 30 (27–34) |
| ≥30 — no. (%) | 316 (47.7) | 330 (50.0) | 194 (47.3) | 189 (47.5) | 155 (46.4) | 157 (48.0) |
| Cardiovascular disease§ | 178 (26.8) | 175 (26.5) | 94 (22.9) | 90 (22.6) | 104 (31.1) | 74 (22.6) |
| Diabetes | 10(1.5) | 16 (2.4) | 8 (2.0) | 5 (1.3) | 4 (1.2) | 3 (0.9) |
| Primary series of vaccines | 359 (54.1) | 331 (50.2) | 222 (54.1) | 227 (57.0) | 186 (55.7) | 187 (57.2) |
| Symptom duration | ||||||
| No. of days | 4.8±1.9 | 4.8±1.9 | 4.6±l.9 | 4.8±1.8 | 5.0±2.2 | 4.7±1.8 |
| ≤4 days — no./total no. (%) | 298/653 (45.6) | 305/642 (47.5) | 199/406 (49.0) | 174/391 (44.5) | 147/330 (44.5) | 146/322 (45.3) |
| Predominant variant — no. (%) | ||||||
| Alpha before 6/19/21 | 79 (11.9) | 80(12.1) | 11 (2.7) | 11 (2.8) | 12 (3.6) | 11 (3.4) |
| Delta from 6/19/21 to 12/12/21 | 440 (66.4) | 431 (65.3) | 278 (67.8) | 275 (69.1) | 278 (83.2) | 275 (84.1) |
| Omicron after 12/12/21 | 144 (21.7) | 149 (22.6) | 121 (29.5) | 112 (28.1) | 46 (14.0) ¶ | 41 (12.5)¶ |
| Insurance status — no. (%) | ||||||
| Medicaid | 92 (13.9) | 108 (16.4) | 70 (17.1) | 60 (15.1) | 43 (12.9) | 42 (12.8) |
| Medicare | 52 (7.8) | 48 (7.3) | 27 (6.6) | 31 (7.8) | 27 (8.1) | 21 (6.4) |
| Private | 410 (61.8) | 413 (62.6) | 257 (62.7) | 230 (57.8) | 206 (61.7) | 197 (60.2) |
| None | 97 (14.6) | 81 (12.3) | 52 (12.7) | 67 (16.8) | 55 (16.5) | 58 (17.7) |
*
Plus-minus values are means ±SD. IQR denotes interquartile range.
†
A total of 6% of the women were pregnant during the trial.
‡
Race or ethnic group was reported by the patients. The category of “other” included patients for whom data were not provided.
§
Cardiovascular disease defined as hypertension, hyperlipidemia, coronary artery disease, past myocardial infarction, heart failure, pacemaker placement, arrhythmias or pulmonary hypertension.
¶
Enrollment in the fluvoxamine group was stopped on January 7, 2022, by the data and safety monitoring board for a lack of conditional power.