TABLE 1

Subject Disposition & Baseline Information (FAS/SS)

Full Analysis Set=Safety SetStatisticAZITHRO + SOCSOCTotal
Total Number of PatientsN11964183
Demographics
 Age [y]Mean (SD)63 (15)59 (15)62 (15)
 Femalen/N (%)40/119 (33.61%)30/ 64 (46.88%)70/183 (38.25%)
  Ethnicity
-­ Caucasiann/N (%)104/119 (87.39%)55/64 (85.94%)159/183 (86.89%)
-­ North African and Middle Eastn/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%)
-­ Othern/N (%)1/119 (0.84%)3/64 (4.68%)4/183 (2.19%)
Medical History
 Diabetes Mellitusn/N (%)22/119 (18.49%)9/ 64 (14.06%)31/183 (16.94%)
 Arterial Hypertensionn/N (%)55/119 (46.22%)27/ 64 (42.19%)82/183 (44.81%)
 Arrhythmian/N (%)19/119 (15.97%)12/ 64 (18.75%)31/183 (16.94%)
  Smoking Status
   Activen/N (%)5/110 (4.55%)4/55 (7.27%)9/165 (5.45%)
   Formern/N (%)37/110 (33.64%)20/55 (36.36%)57/165 (34.55%)
   Nevern/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%)
  COPDn/N (%)7/119 (5.88%)8/ 64 (12.50%)15/183 (8.20%)
  Asthman/N (%)10/119 (8.40%)5/ 64 (7.81%)15/183 (8.20%)
  Heart Failuren/N (%)8/119 (6.72%)3/ 64 (4.69%)11/183 (6.01%)
  Ischemic Heart Diseasen/N (%)10/119 (8.40%)8/ 64 (12.50%)18/183 (9.84%)
  Chronic Kidney Diseasen/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 ventilationn/N (%)5/119 (4.20%)4/ 64 (6.25%)9/183 (4.92%)
-­ Mechanical Ventilationn/N (%)0/119 (0.00%)3/ 64 (4.69%)3/183 (1.64%)
-­ ECMOn/N (%)1/119 (0.84%)0/ 64 (0.00%)1/183 (0.55%)
Clinical Status at Baseline
3. Hosp., not requiring supplemental oxygenn/N (%)22/119 (18.49%)14/64 (21.88%)36/183 (19.67%)
4. Hosp., requiring supplemental oxygenn/N (%)88/119 (73.95%)43/64 (67.19%)131/183 (71.58%)
5. Hosp., on non-invasive ventilationn/N (%)9/119 (7.56%)5/64 (7.81%)14/183 (7.65%)
6. Hosp., on inv. MV or ECMOn/N (%)0/119 (0.00%)2/64 (3.13%)2/183 (1.09%)
7. Deathn/N (%)0/119 (0.00%)0/64 (0.00%)0/183 (0.00%)
Laboratory Parameters at Baseline
 CRP [mg/L] Ref. ≤ 5Median (Q1; Q3)73.8 (35.2; 125.8)59.5 (23.5; 93.3)68.0 (33.1; 119.2)
 WBC [109/L]Ref. 4.0–10.0Median (Q1; Q3)6.0 (4.2; 8.0)5.6 (4.1; 8.0)5.8 (4.2; 8.0)
 Lymphocytes [109/L]Ref. 1.2–3.6Median (Q1; Q3)1.0 (0.7; 1.4)1.0 (0.7; 1.3)1.0 (0.7; 1.4)
 Neutrophils [109/L]Ref. 2.5–7.8Median (Q1; Q3)4.4 (2.9; 6.5)4.5 (3.4; 6.7)4.5 (3.0; 6.6)
 Ferritin [µg/L]Ref. 30–400Median (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. ≤ 500Median (Q1; Q3)743.0 (466.0; 1174.0)670.0 (378.0; 958.0)723.5 (455.5; 1160.0)
 Fibrinogen [g/L]Ref. 2.0–3.93Median (Q1; Q3)7.7 (5.6; 560.0)139.2 (4.5; 547.0)9.3 (5.3; 547.0)
 eGFR [mL/min]Ref. ≥ 60Median (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.