Table 3a. Anti-SARS-CoV-2 Monoclonal Antibodies: Selected Clinical Data

Last Updated: October 19, 2021

This table describes only clinical trials that have evaluated anti-SARS-CoV-2 mAbs for the treatment of COVID-19. Please refer to the Prevention of SARS-CoV-2 Infection section for a discussion of clinical trials that have evaluated anti-SARS-CoV-2 mAbs for PEP of SARS-CoV-2 infection.

Table 3a. Anti-SARS-CoV-2 Monoclonal Antibodies: Selected Clinical Data
Methods Results Limitations and Interpretation
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.
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.
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.
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.