Subject Disposition & Baseline Information (FAS/SS)
| Full Analysis Set=Safety Set | Statistic | AZITHRO + SOC | SOC | Total | |
| Total Number of Patients | N | 119 | 64 | 183 | |
| Demographics | |||||
| Age [y] | 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 African 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%) | |
| Ischemic 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/min) | n/N (%) | 57/119 (47.90%) | 33/ 61 (54.10%) | 90/180 (50.00%) | |
| Respiratory Support within First 2 Hours | |||||
| - 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 non-invasive 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 non-invasive ventilation | n/N (%) | 9/119 (7.56%) | 5/64 (7.81%) | 14/183 (7.65%) | |
| 6. Hosp., on inv. 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] | 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] | 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] | 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] | 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] | 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) | [111] 418.9 (25.3) | [57] 416.5 (28.6) | [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) | |
Abbreviations: Ref: reference value, CRP: C-reactive protein, WBC: white blood cell count.