Table 1. Characteristics of the Patients at Baseline (Intention-to-Treat Population).*.
| Characteristic | Hydroxychloroquine plus Azithromycin (N=217) |
Hydroxychloroquine (N=221) |
Control (N=227) |
Total (N=665) |
|---|---|---|---|---|
| Age — yr | 49.6±14.2 | 51.3±14.5 | 49.9±15.1 | 50.3±14.6 |
| Male sex — no. (%) | 123 (56.7) | 142 (64.3) | 123 (54.2) | 388 (58.3) |
| Coexisting condition — no. (%) | ||||
| Hypertension | 81 (37.3) | 94 (42.5) | 83 (36.6) | 258 (38.8) |
| Diabetes | 40 (18.4) | 47 (21.3) | 40 (17.6) | 127 (19.1) |
| Current or former smoking | 17 (7.8) | 12 (5.4) | 15 (6.6) | 44 (6.6) |
| Obesity | 29 (13.4) | 37 (16.7) | 37 (16.3) | 103 (15.5) |
| Cancer | 7 (3.2) | 4 (1.8) | 8 (3.5) | 19 (2.9) |
| Heart failure | 4 (1.8) | 3 (1.4) | 3 (1.3) | 10 (1.5) |
| COPD | 4 (1.8) | 4 (1.8) | 4 (1.8) | 12 (1.8) |
| AIDS | 1 (0.5) | 0 | 3 (1.3) | 4 (0.6) |
| Chronic renal disease | 2 (0.9) | 1 (0.5) | 2 (0.9) | 5 (0.8) |
| Asthma | 16 (7.4) | 9 (4.1) | 15 (6.6) | 40 (6.0) |
| Previous medication use — no. (%) | ||||
| Glucocorticoid | 4 (1.8) | 1 (0.5) | 3 (1.3) | 8 (1.2) |
| ACE inhibitor | 16 (7.4) | 19 (8.6) | 13 (5.7) | 48 (7.2) |
| Angiotensin II–receptor antagonist | 39 (18.0) | 36 (16.3) | 41 (18.1) | 116 (17.4) |
| NSAID | 8 (3.7) | 12 (5.4) | 9 (4.0) | 29 (4.4) |
| Randomization location — no. (%) | ||||
| Emergency department or ward | 187 (86.2) | 189 (85.5) | 197 (86.8) | 573 (86.2) |
| ICU | 30 (13.8) | 32 (14.5) | 30 (13.2) | 92 (13.8) |
| Testing for Covid-19 — no. (%) | ||||
| Positive on RT-PCR | 172 (79.3) | 159 (71.9) | 173 (76.2) | 504 (75.8) |
| Negative on RT-PCR or unavailable | 45 (20.7) | 62 (28.1) | 54 (23.8) | 161 (24.2) |
| Score on seven-level ordinal scale — no. (%)† | ||||
| 3: Hospitalized and not receiving supplemental oxygen | 125 (57.6) | 132 (59.7) | 130 (57.3) | 387 (58.2) |
| 4: Hospitalized and receiving supplemental oxygen | 92 (42.4) | 89 (40.3) | 97 (42.7) | 278 (41.8) |
| Use of trial medication‡ | ||||
| Hydroxychloroquine — no. (%) | 23 (10.6) | 20 (9.0) | 19 (8.4) | 62 (9.3) |
| Azithromycin — no./total no. (%) | 74/217 (34.1) | 76/221 (34.4) | 90/226 (39.8) | 240/664 (36.1) |
| Median time from admission to randomization (IQR) — days | 1 (0–1) | 1 (0–1) | 1 (0–1) | 1 (0–1) |
| Median time from symptom onset to randomization (IQR) — days | 7 (5–9) | 7 (5–8) | 7 (4–9) | 7 (5–9) |
Plus-minus values are means ±SD. The intention-to-treat population included all the patients who had undergone randomization. Information on coexisting conditions was obtained from the medical records. The values shown are based on available data. Percentages may not total 100 because of rounding. ACE denotes angiotensin-converting enzyme, AIDS acquired immunodeficiency syndrome, COPD chronic obstructive pulmonary disease, ICU intensive care unit, IQR interquartile range, NSAID nonsteroidal antiinflammatory drug, and RT-PCR reverse transcriptase–polymerase chain reaction.
Only hospitalized patients who were not receiving supplemental oxygen or who were receiving up to 4 liters per minute of supplemental oxygen were eligible for the trial. Patients who had scores on other levels of the seven-level ordinal scale were not eligible.
Use of trial medication was defined as the use of hydroxychloroquine or azithromycin during the 24-hour period before randomization.