Table 1.
Key clinical outcomes from the phase 2 and phase 3 portions of the BLAZE-1 trial of bamlanivimab and etesevimab together for patients with mild-to-moderate COVID-19
| BLAZE-1 clinical trial | ||||
|---|---|---|---|---|
| Phase 2 portion | Phase 3 portion1 | |||
| Bamlanivimab and etesevimab (2800/2800 mg) |
Placebo | Bamlanivimab and etesevimab (2800/2800 mg) |
Placebo | |
| Entire cohort (N = 112) |
(N = 156) | High-risk cohort (N = 512) |
(N = 517) | |
| Hospitalization, ED visits, and deaths | ||||
| Proportion of patients with COVID-19-related hospitalization, ER visits, or deaths, % |
0.9 p = 0.075 |
5.8 |
2.3 p < 0.001 |
7.0 |
| Mean duration of hospitalization, days (SD) | 0 | 9.6 (5.5) | 7.3 (6.4) | 11.2 (10.1) |
| Deaths | 0 | 0 | 0 | 10 |
| Viral load | ||||
| Change in log viral load from baseline to day 7, LSM (SE) |
− 3.78 (0.175) p < 0.001 |
− 2.66 (0.144) |
− 3.66 (0.090) p < 0.001 |
− 2.46 (0.095) |
| Median time to viral clearance, days | 21 | 24 | ||
| Symptomology2 | ||||
| Change in symptomology viral load from baseline to day 7, LSM (SE) |
− 4.19 (0.287) p < 0.001 |
− 3.88 (0.246) | ||
|
Proportion of patients with symptomology Improvement at day 7, % |
45.9 | 40.8 | 34.4 | 26.5 |
|
Proportion of patients with symptomology Resolution at day 7, % |
34.9 | 31.6 | 44.1 | 35.5 |
| Time to sustained symptomology resolution, days | 9 | 12 | 8 | 9 |
ER emergency room, LSM least squares mean, SE standard error, SD standard deviation, N number of patients in cohort, n proportion of cohort, p p value versus placebo
1Endpoints differed in phase 2 and phase 3 portions of BLAZE-1 trial, therefore not all data available across phases. The median time to viral clearance is not available as less than 50% of each cohort of patients achieved viral clearance within the observation period (29 days). Phase 3 data for the patients who received bamlanivimab and etesevimab together (700/1400 mg) is not yet published
2Symptom presence and severity of COVID-19 were assessed using a symptoms questionnaire and included symptoms of cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite. Symptom severity was scored as 0, 1, 2, or 3 corresponding to the symptom being absent, mild, moderate, or severe, respectively. Participants also rated changes in taste and smell with a yes/no response. Change in symptomology was evaluated on the basis of the total symptom questionnaire score (the sum of individual symptom scores). The definition of symptomatology resolution was an absence of all symptoms (phase 2), though it was amended for phase 3 data analysis to exclude a mild cough or fatigue