| BLAZE-1: Double-Blind, Phase 3 RCT of Bamlanivimab 700 mg Plus Etesevimab 1,400 mg in Nonhospitalized Patients With Mild to Moderate COVID-191 |
Key Inclusion Criteria: - Aged ≥12 years
- At high risk for severe COVID-19 or hospitalization
Interventions: - Within 3 days of a positive SARS-CoV-2 test result, single infusion of:
- BAM 700 mg plus ETE 1,400 mg (n = 511)
- Placebo (n = 258)
Primary Endpoint: - Proportion of patients with COVID-19-related hospitalization (defined as ≥24 hours of acute care) or all-cause death by Day 29
| Participant Characteristics: - Median age 56 years; 30% ≥65 years; 53% female
- 87% White; 27% Hispanic/Latinx; 8% Black/African American
- Mean duration of symptoms was 4 days.
- 76% had mild COVID-19 and 24% had moderate COVID-19.
Primary Outcomes: - COVID-19-related hospitalizations or all-cause deaths by Day 29: 4 (0.8%) in BAM plus ETE arm vs. 15 (6%) in placebo arm; relative risk difference: 87%; P <0.0001.
- All-cause deaths by Day 29: 0 in BAM plus ETE arm vs. 4 (1.6%) in placebo arm; P = 0.01.
| Key Limitation: - Trial results not yet published in peer-reviewed journal
Interpretation: - Compared to placebo, receipt of BAM plus ETE was associated with 5% absolute reduction and 87% relative reduction in COVID-19-related hospitalizations or all-cause deaths.
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| BLAZE-1: Double-Blind, Phase 3 RCT of Bamlanivimab 2,800 mg Plus Etesevimab 2,800 mg in Nonhospitalized Patients With Mild to Moderate COVID-192 |
Key Inclusion Criteria: - Aged ≥12 years
- At high risk for severe COVID-19 or hospitalization
Key Exclusion Criteria: - SpO2 ≤93% on room air, or
- Respiratory rate ≥30 breaths/min, or
- Heart rate ≥125 bpm
Interventions: - Within 3 days of a positive SARS-CoV-2 test result, single infusion of:
- BAM 2,800 mg plus ETE 2,800 mg (n = 518)
- Placebo (n = 517)
Primary Endpoint: - Proportion of patients with COVID-19-related hospitalization or all-cause death by Day 29
Secondary Endpoint: - Proportion of patients with SARS-CoV-2 VL >5.27 log10 copies/mL at Day 7
| Participant Characteristics: - Mean age 53.8 years; 31% ≥65 years; 52% female; 48% male
- 87% White; 29% Hispanic/Latinx; 8% Black/African American
- Median days from symptom onset to infusion was 4 days.
- 77% had mild COVID-19.
Primary Outcomes: - COVID-19-related hospitalizations or all-cause deaths by Day 29: 11 (2.1%) in BAM plus ETE arm vs. 36 (7.0%) in placebo arm; relative risk difference: 70%; P < 0.001.
- All-cause deaths by Day 29: 0 in BAM plus ETE arm vs. 10 (1.9%) in placebo arm.
Secondary Outcome: - Proportion of patients with high VL at Day 7: 9.8% in BAM plus ETE arm vs. 29.5% in placebo arm (P < 0.001)
| Interpretation: - Compared to placebo, receipt of BAM plus ETE was associated with 4.8% absolute reduction and 70% relative reduction in COVID-19-related hospitalizations or all-cause deaths.
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| Double-Blind, Phase 3 RCT of Casirivimab Plus Imdevimab in Nonhospitalized Patients With Mild to Moderate COVID-193 |
Key Inclusion Criteria: - Aged ≥18 years
- Positive SARS-CoV-2 diagnostic test result
- Symptom onset within 7 days of randomization
- For patients included in the modified full analysis only:
- ≥1 risk factor for severe COVID-19
- Positive SARS-CoV-2 RT-PCR result at baseline
Interventions: - Single IV infusion of:
- CAS 600 mg plus IMD 600 mg (n = 736) or placebo (n = 748)
- CAS 1,200 mg plus IMD 1,200 mg (n = 1,355) or placebo (n = 1,341)
Primary Endpoint: - Proportion of patients with COVID-19-related hospitalization or all-cause death through Day 29
| Participant Characteristics: - Median age 50 years; 35% Hispanic/Latinx; 5% Black/African American
- Median duration of symptoms prior to enrollment was 3 days.
Primary Outcomes: - COVID-19-related hospitalizations or all-cause deaths through Day 29:
- 7 (1.0%) in CAS 600 mg plus IMD 600 mg arm vs. 24 (3.2%) in placebo arm (P = 0.002).
- 18 (1.3%) in CAS 1,200 mg plus IMD 1,200 mg arm vs. 62 (4.6%) in placebo arm (P < 0.001).
- All-cause deaths:
- 1 (0.1%) in CAS 600 mg plus IMD 600 mg arm vs. 1 (0.1%) in placebo arm.
- 1 (< 0.1%) in CAS 1,200 mg plus IMD 1,200 mg arm vs. 3 (0.2%) in placebo arm.
| Interpretation: - Compared to placebo, receipt of CAS 600 mg plus IMD 600 mg was associated with 2.2% absolute reduction and 70% relative risk reduction in COVID-19-related hospitalizations or all-cause deaths.
- Compared to placebo, receipt of CAS 1,200 mg plus IMD 1,200 mg was associated with 3.3% absolute reduction and 71% relative risk reduction in COVID-19-related hospitalizations or all-cause deaths.
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| COMET-ICE: Double-Blind, Phase 3 RCT of Sotrovimab in Nonhospitalized Patients With Mild to Moderate COVID-19 Interim Analysis4 |
Key Inclusion Criteria: - Aged ≥18 years with ≥1 comorbidity or aged ≥55 years regardless of comorbidities
- Laboratory-confirmed COVID-19
- Symptom onset ≤5 days before enrollment
Key Exclusion Criteria: - Hospitalized or requiring supplemental oxygen
- Severely immunocompromised
Interventions: - SOT 500 mg IV (n = 291)
- Placebo (n = 292)
Primary Endpoint: - Proportion of patients with all-cause hospitalization or death by Day 29
| Participant Characteristics: - Median age 53 years; 22% ≥65 years
- 63% Hispanic/Latinx; 7% Black/African American
Primary Outcome: - All-cause hospitalizations or deaths by Day 29: 3 (1%) in SOT arm vs. 21 (7%) in placebo arm (P = 0.002).
| Key Limitation: - Trial results not yet published in peer-reviewed journal
Interpretation: - Compared to placebo, receipt of SOT was associated with 6% absolute reduction and 85% relative risk reduction in all-cause hospitalizations or deaths.
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