Table 1. Baseline Patient Characteristics.
| Characteristic | No. (%) | |
|---|---|---|
| Hydroxychloroquine (n = 242) | Placebo (n = 237) | |
| Age, median (IQR), y | 58 (45-69) | 57 (43-68) |
| Sex | ||
| Female | 107 (44.2) | 105 (44.3) |
| Male | 135 (55.8) | 132 (55.7) |
| Race/ethnicity | n = 232 | n = 227 |
| Hispanic/Latinx | 91 (39.2) | 87 (38.3) |
| Non-Hispanic | ||
| White | 72 (31.0) | 65 (28.6) |
| Black | 57 (24.6) | 55 (24.2) |
| American Indian or Alaska Native | 5 (2.2) | 8 (3.5) |
| Asian | 4 (1.7) | 7 (3.1) |
| Native Hawaiian or Other Pacific Islander | 2 (0.9) | 4 (1.8) |
| Multirace | 1 (0.4) | 1 (0.4) |
| Living at home in the community prior to hospitalization | 190 (78.5) | 183 (77.2) |
| Body mass index, median (IQR)a | 31.3 (26.4-37.2) | 31.1 (27.2-36.5) |
| No. | 226 | 219 |
| Chronic conditions | ||
| Hypertension | 136 (56.2) | 117 (49.4) |
| Diabetes | 88 (36.4) | 78 (32.9) |
| Chronic kidney disease | 28 (11.6) | 14 (5.9) |
| Coronary artery disease | 19 (7.9) | 23 (9.7) |
| Chronic obstructive pulmonary disease | 18 (7.4) | 21 (8.9) |
| Location at time of randomization | n = 228 | n = 224 |
| Hospital ward | 157 (68.9) | 132 (58.9) |
| Intensive care unit | 37 (16.2) | 54 (24.1) |
| Emergency department | 34 (14.9) | 38 (17.0) |
| Symptoms of acute respiratory infection | ||
| Shortness of breath | 175 (72.3) | 168 (70.9) |
| Cough | 143 (59.1) | 140 (59.1) |
| Fever (temperature >37.5 °C) | 138 (57.0) | 132 (55.7) |
| Duration of symptoms prior to randomization, median (IQR), d | 5 (3-7) | 5 (3-7) |
| Time between hospital presentation and randomization, median (IQR), hb | 22.2 (14.6-33.1) | 22.7 (14.1-29.9) |
| No. | 240 | 234 |
| COVID Outcomes Scale category at randomizationc | ||
| 2: Hospitalized, receiving ECMO or invasive mechanical ventilation | 13 (5.4) | 19 (8.0) |
| 3: Hospitalized, receiving noninvasive ventilation or nasal high-flow oxygen | 28 (11.6) | 27 (11.4) |
| 4: Hospitalized, receiving supplemental oxygen without positive pressure or high flow | 116 (47.9) | 108 (45.6) |
| 5: Hospitalized, not receiving supplemental oxygen | 85 (35.1) | 83 (35.0) |
| Vasopressor use at enrollment | 8 (3.3) | 20 (8.4) |
| Total SOFA score at enrollment, median (IQR)d | 2 (1-4) | 2 (1-4) |
| Laboratory measurementse | ||
| White blood cell count, median (IQR), ×103/μL (normal range, 3.9-10.7) | 6.0 (4.3-7.9) | 5.9 (4.1-7.7) |
| No. | 224 | 218 |
| Platelet count, median (IQR), ×103/μL (normal range, 135-371) | 199 (151-247) | 200 (147-251) |
| No. | 237 | 230 |
| Creatinine, median (IQR), mg/dL (normal range, 0.57-1.11) | 0.90 (0.75-1.47) | 0.90 (0.75-1.25) |
| No. | 235 | 231 |
| Aspartate aminotransferase, median (IQR), U/L (normal range, 5-40) | 39 (29-62) | 45 (31-70) |
| No. | 173 | 184 |
| Alanine aminotransferase, median (IQR), U/L (normal range, 0-55) | 30 (18-47) | 34 (23-62) |
| No. | 174 | 183 |
| Bilateral infiltrates on chest imagingf | 147/230 (63.9) | 145/230 (63.0) |
| QTc interval, median (IQR), msg | 430 (414-452) | 435 (416-452) |
| No. | 242 | 236 |
Abbreviations: COVID, coronavirus disease; ECMO, extracorporeal membrane oxygenation; IQR, interquartile range; SOFA, Sequential Organ Failure Assessment.
SI conversion factors: To convert aspartate aminotransferase and alanine aminotransferase to μkat/L, multiply by 0.0167; creatinine to μmol/L, multiply by 88.4.
Calculated as weight in kilograms divided by height in meters squared.
Defined as the time of the first contact with an acute care hospital during the health care episode that resulted in the hospitalization during which the patient was enrolled. For patients who initially presented to the emergency department, time of hospital presentation was the time of emergency department arrival. For patients directly hospitalized without presenting to the emergency department, time of hospital presentation was the time of arrival at the admission unit.
The COVID Outcomes Scale is a 7-category ordinal scale that classifies a patient’s clinical status.19 Lower scores indicate more severely ill clinical status. Patients in the following categories at baseline were not eligible for enrollment: category 1 (death); category 6 (not hospitalized and unable to perform normal activities); and category 7 (not hospitalized and able to perform normal activities).
The SOFA score23 categorizes illness severity based on organ dysfunction across 6 organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and kidney. SOFA scores range from 0 to 24, with higher scores indicating greater illness severity. A SOFA score of 2 indicates moderate dysfunction in 1 organ system or mild dysfunction in 2 organ systems.
Laboratory normal ranges were reported base on the clinical laboratory normal ranges from Vanderbilt University Medical Center. Normal ranges may vary across laboratories.
Reported chest imaging interpretations were based on final interpretation from radiologists.
Reported QTc was based on automated readings.