Subject disposition and baseline information: full analysis set/safety set
| Full analysis set=safety set | Statistic | AZITHRO + SOC | SOC | Total | |
| Total number of patients | n | 119 | 64 | 183 | |
| Demographics | |||||
| Age years | Mean±sd | 63±15 | 59±15 | 62±15 | |
| Female | n/N (%) | 40/119 (33.61) | 30/64 (46.88) | 70/183 (38.25) | |
| Ethnicity | |||||
| Caucasian | n/N (%) | 104/119 (87.39) | 55/64 (85.94) | 159/183 (86.89) | |
| North Africa and Middle East | n/N (%) | 11/119 (9.24) | 5/64 (7.69) | 16/183 (8.74) | |
| Black or sub-Sahara (Africa) | n/N (%) | 3/119 (2.52) | 1/64 (1.56) | 4/183 (2.19) | |
| Other | n/N (%) | 1/119 (0.84) | 3/64 (4.68) | 4/183 (2.19) | |
| Medical history | |||||
| Diabetes mellitus | n/N (%) | 22/119 (18.49) | 9/64 (14.06) | 31/183 (16.94) | |
| Arterial hypertension | n/N (%) | 55/119 (46.22) | 27/64 (42.19) | 82/183 (44.81) | |
| Arrhythmia | n/N (%) | 19/119 (15.97) | 12/64 (18.75) | 31/183 (16.94) | |
| Smoking status | |||||
| Active | n/N (%) | 5/110 (4.55) | 4/55 (7.27) | 9/165 (5.45) | |
| Former | n/N (%) | 37/110 (33.64) | 20/55 (36.36) | 57/165 (34.55) | |
| Never | n/N (%) | 68/110 (61.82) | 31/55 (56.36) | 99/165 (60.00) | |
| Chronic pulmonary disease# | n/N (%) | 4/119 (3.36) | 2/63 (3.17) | 6/182 (3.30) | |
| COPD | n/N (%) | 7/119 (5.88) | 8/64 (12.50) | 15/183 (8.20) | |
| Asthma | n/N (%) | 10/119 (8.40) | 5/64 (7.81) | 15/183 (8.20) | |
| Heart failure | n/N (%) | 8/119 (6.72) | 3/64 (4.69) | 11/183 (6.01) | |
| Ischaemic heart disease | n/N (%) | 10/119 (8.40) | 8/64 (12.50) | 18/183 (9.84) | |
| Chronic kidney disease | n/N (%) | 10/119 (8.40) | 6/64 (9.38) | 16/183 (8.74) | |
| Respiratory status at first presentation | |||||
| Signs of respiratory distress at first presentation (i.e. oxygen saturation <93%, PaO2/FIO2 <300 mmHg, respiratory rate >30 breaths·min−1) | n/N (%) | 57/119 (47.90) | 33/61 (54.10) | 90/180 (50.00) | |
| Respiratory support within first 2 h | |||||
| Oxygen support (oxygen mask or nasal prongs) | n/N (%) | 89/119 (74.79) | 46/63 (73.02) | 135/182 (74.18) | |
| High-flow oxygen support or noninvasive ventilation | n/N (%) | 5/119 (4.20) | 4/64 (6.25) | 9/183 (4.92) | |
| Mechanical ventilation | n/N (%) | 0/119 (0.00) | 3/64 (4.69) | 3/183 (1.64) | |
| ECMO | n/N (%) | 1/119 (0.84) | 0/64 (0.00) | 1/183 (0.55) | |
| Clinical status at baseline | |||||
| 3) Hosp., not requiring supplemental oxygen | n/N (%) | 22/119 (18.49) | 14/64 (21.88) | 36/183 (19.67) | |
| 4) Hosp., requiring supplemental oxygen | n/N (%) | 88/119 (73.95) | 43/64 (67.19) | 131/183 (71.58) | |
| 5) Hosp., on noninvasive ventilation | n/N (%) | 9/119 (7.56) | 5/64 (7.81) | 14/183 (7.65) | |
| 6) Hosp., on invasive MV or ECMO | n/N (%) | 0/119 (0.00) | 2/64 (3.13) | 2/183 (1.09) | |
| 7) Death | n/N (%) | 0/119 (0.00) | 0/64 (0.00) | 0/183 (0.00) | |
| Laboratory parameters at baseline | |||||
| CRP mg·L−1 | Ref. ≤5 | Median (Q1–Q3) | 73.8 (35.2–125.8) | 59.5 (23.5–93.3) | 68.0 (33.1–119.2) |
| WBC 109/L | Ref. 4.0–10.0 | Median (Q1–Q3) | 6.0 (4.2–8.0) | 5.6 (4.1–8.0) | 5.8 (4.2–8.0) |
| Lymphocytes 109/L | Ref. 1.2–3.6 | Median (Q1–Q3) | 1.0 (0.7–1.4) | 1.0 (0.7–1.3) | 1.0 (0.7–1.4) |
| Neutrophils 109/L | Ref. 2.5–7.8 | Median (Q1–Q3) | 4.4 (2.9–6.5) | 4.5 (3.4–6.7) | 4.5 (3.0–6.6) |
| Ferritin µg·L−1 | Ref. 30–400 | Median (Q1–Q3) | 722.5 (408.0–1057.0) | 748.0 (529.0–1420.0) | 736.0 (492.0–1259.0) |
| D-dimer µg·L−1 | Ref. ≤500 | Median (Q1–Q3) | 743.0 (466.0–1174.0) | 670.0 (378.0–958.0) | 723.5 (455.5–1160.0) |
| Fibrinogen g·L−1 | Ref. 2.0–3.93 | Median (Q1–Q3) | 7.7 (5.6–560.0) | 139.2 (4.5–547.0) | 9.3 (5.3–547.0) |
| eGFR mL·min−1 | Ref. ≥60 | Median (Q1–Q3) | 82.0 (64.0–90.0) | 88.0 (74.0–90.0) | 85.0 (65.0–90.0) |
| ECG at baseline | |||||
| QTc (MS) (Fridericia formula) | n, mean±sd | n=111, 418.9±25.3 | n=57, 416.5±28.6 | n=168, 418.1±26.4 | |
| Symptom onset | |||||
| Time from symptom onset to randomisation, days | Median (Q1–Q3) | 7 (4–10) | 7 (5–10) | 7 (5–10) | |
AZITHRO: azithromycin; SOC: standard of care; PaO2: arterial oxygen tension; FIO2: inspiratory oxygen fraction; ECMO: extracorporeal membrane oxygenation; Hosp.: hospitalised; MV: mechanical ventilation; Ref: reference value; CRP: C-reactive protein; WBC: white blood cell count; eGFR: estimated glomerular filtration rate. #: not COPD or asthma.