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

Last Updated: April 29, 2022

This table describes only the clinical trials that have evaluated anti-SARS-CoV-2 mAbs for the treatment of COVID-19. Please see Prevention of SARS-CoV-2 Infection for a discussion of the 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 RCT of Bamlanivimab 700 mg Plus Etesevimab 1,400 mg in Nonhospitalized Patients With Mild to Moderate COVID-19 in the United States and Puerto Rico1
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:

  • COVID-19-related hospitalization (defined as ≥24 hours of acute care) or death from any cause by Day 29

Participant Characteristics:

  • Median age 56 years; 30% aged ≥65 years; 53% women
  • 87% White, 27% Hispanic/Latinx, 8% Black/African American
  • Mean duration of symptoms was 4 days
  • 76% with mild COVID-19, 24% with 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 (5.8%) in placebo arm (change of -5.0%; 95% CI, -8.0% to -2.1%; P < 0.001)
  • All-cause deaths by Day 29: 0 in BAM plus ETE arm vs. 4 (1.6%) in placebo arm
Key Limitation: 
  • Conducted before widespread circulation of the Omicron VOC

Interpretation:

  • Compared to placebo, BAM plus ETE significantly reduced the number of COVID-19-related hospitalizations and all-cause deaths in high-risk patients.
BLAZE-4, Treatment Arms 9–11: Double-Blind RCT of Bamlanivimab Plus Etesevimab Plus Bebtelovimab Versus Bebtelovimab Alone Versus Placebo in Low-Risk, Nonhospitalized Patients With Mild to Moderate COVID-192
Key Inclusion Criteria:
  • Aged 18–64 years
  • No risk factors for progression to severe COVID-19

Key Exclusion Criteria:

  • ≥1 of the following:
    • SpO2 ≤93% on room air
    • Respiratory rate ≥30 breaths/min
    • Heart rate ≥125 bpm

Interventions:

  • Within 3 days of a positive SARS-CoV-2 test result, single infusion of:
    • BAM 700 mg plus ETE 1,400 mg plus BEB 175 mg (n = 127)
    • BEB 175 mg (n = 125)
    • Placebo (n = 128)

Primary Endpoint:

  • Proportion of patients with PHVL (defined as SARS-CoV-2 VL >5.82 log10 by Day 7)

Key Secondary Endpoints:

  • Mean change in VL from baseline to Days 3, 5, 7, and 11
  • COVID-19-related hospitalization or death from any cause by Day 29
  • Time to sustained symptom resolution

Participant Characteristics:

  • Median age 35 years; 56% women
  • 36% Hispanic/Latinx, 19% Black/African American
  • Mean duration of symptoms prior to enrollment was 3.6 days

Primary Outcomes:

  • Proportion with PHVL:
    • 13% in BAM plus ETE plus BEB arm vs. 21% in placebo arm (P = 0.098), with a relative reduction of 38% (95% CI, -9% to 65%)
    • 14% in BEB arm vs. 21% in placebo arm (P = 0.147), with a relative reduction of 34% (95% CI, -15% to 62%)

Secondary Outcomes:

  • Mean decline in VL greater in mAb arms vs. placebo arm at Day 5 but not at Days 3, 7, or 11
  • COVID-19-related hospitalizations or all-cause deaths by Day 29:
    • 3 (2.4%) in BAM plus ETE plus BEB arm, including 1 death
    • 2 (1.6%) in BEB arm 
    • 2 (1.6%) in placebo arm
  • Median time to sustained symptom resolution:
    • 7 days in BAM plus ETE plus BEB arm vs. 8 days in placebo arm (P = 0.289)
    • 6 days in BEB arm vs. 8 days in placebo arm (P = 0.003)

Key Limitations:

  • Only low-risk patients included 
  • Not powered to assess hospitalizations and deaths
  • Conducted before widespread circulation of the Omicron VOC

Interpretations:

  • There were no differences in the proportion of patients with PHVL across the arms.
  • Few COVID-19-related hospitalizations or deaths from any cause occurred by Day 29 across the arms, as is expected for a population of individuals who were at low risk of severe COVID-19.
  • Compared to placebo, the median time to sustained symptom resolution was shorter in the BEB arm. 
BLAZE-4, Treatment Arms 12 and 13: Open-Label RCT of Bamlanivimab Plus Etesevimab Plus Bebtelovimab and Bebtelovimab Alone in High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-192

Key Inclusion Criteria:

  • Aged ≥12 years
  • Weight ≥40 kg
  • ≥1 risk factor for progression to severe COVID-19

Key Exclusion Criteria:

  • ≥1 of the following:
    • SpO2 ≤93% on room air
    • Respiratory rate ≥30 breaths/min
    • Heart rate ≥125 bpm

Interventions:

  • Within 3 days of a positive SARS-CoV-2 test result, single infusion of:
    • BAM 700 mg plus ETE 1,400 mg plus BEB 175 mg (n = 50)
    • BEB 175 mg (n = 100)

Efficacy Endpoints:

  • COVID-19-related hospitalization or death from any cause by Day 29
  • Mean change in VL from baseline to Days 3, 5, 7, and 11

Participant Characteristics:

  • Median age 50 years; 52% women
  • 18% Hispanic/Latinx, 18% Black/African American
  • Mean duration of symptoms prior to enrollment was 4.7 days 
  • 21% had at least 1 dose of COVID-19 vaccine

Efficacy Outcomes:

  • COVID-19-related hospitalization or death from any cause by Day 29: 2 (4%) in BAM plus ETE plus BEB arm vs. 3 (3%) in BEB arm 
  • Mean decline in VL greater in BAM plus ETE plus BEB arm vs. BEB arm at Day 5 but not at Days 3, 7, or 11

Key Limitations:

  • Open-label study
  • No placebo arm
  • Not powered to assess hospitalizations and deaths
  • Conducted before widespread circulation of the Omicron VOC

Interpretation:

  • There was no difference in the proportion of patients who were hospitalized or who died between the arms.
Double-Blind RCT of Casirivimab Plus Imdevimab in Nonhospitalized Patients With Mild to Moderate COVID-193

Key Inclusion Criteria:

  • Aged ≥18 years
  • Laboratory-confirmed SARS-CoV-2 infection 
  • 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:

  • ≥1 COVID-19-related hospitalization or death from any cause by 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

Key Limitation: 

  • Conducted before widespread circulation of the Omicron VOC

Interpretation:

  • Compared to placebo, CAS 600 mg plus IMD 600 mg and CAS 1,200 mg plus IMD 1,200 mg reduced the risk of COVID-19-related hospitalizations or all-cause deaths in patients with mild to moderate COVID-19.
COMET-ICE: Double-Blind RCT of Sotrovimab in Nonhospitalized Patients With Mild to Moderate COVID-19 in Brazil, Canada, Peru, Spain, and the United States4

Key Inclusion Criteria:

  • Aged ≥18 years
  • ≥1 comorbidity or aged ≥55 years
  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • Symptom onset ≤5 days before enrollment

Key Exclusion Criteria:

  • Hospitalized or required supplemental oxygen
  • Severely immunocompromised

Interventions:

  • SOT 500 mg IV (n = 528)
  • Placebo (n = 529)

Primary Endpoint:

  • Hospitalization or death from any cause by Day 29

Participant Characteristics:

  • Median age 53 years; 20% aged ≥65 years; 54% women
  • 65% Hispanic/Latinx, 8% Black/African American
  • 63% with obesity; 22% with DM; 17% with moderate to severe asthma 

Primary Outcome:

  • Hospitalizations or all-cause deaths by Day 29: 6 (1%) in SOT arm vs. 30 (6%) in placebo arm, including 2 deaths (adjusted relative risk 0.21; 95% CI, 0.09–0.50; absolute difference -4.53%; 95% CI, -6.70% to -2.37%; P < 0.001) 

Key Limitation: 

  • Conducted before widespread circulation of the Omicron VOC

Interpretation:

  • Compared to placebo, SOT reduced the incidence of all-cause hospitalizations and deaths among patients with mild to moderate COVID-19.

References

  1. Dougan M, Azizad M, Mocherla B, et al. A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load. Clin Infect Dis. 2021;Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34718468.
  2. Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. 2022. Available at: https://www.fda.gov/media/156152/download.
  3. Weinreich DM, Sivapalasingam S, Norton T, et al. REGEN-COV antibody combination and outcomes in outpatients with COVID-19. N Engl J Med. 2021;385(23):e81. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34587383.
  4. Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Effect of sotrovimab on hospitalization or death among high-risk patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2022;327(13):1236-1246. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35285853.