Casirivimab

An anti-Spike (SARS-CoV-2) antibody.

Phase of research

Emergency use authorization

How it helps

Antiviral

Drug status

Experimental

4
Supporting references
11
Contradictory references
20
Clinical trials

General information

Casirivimab is a fully human monoclonal antibody targeting and neutralizing SARS-CoV-2 Spike protein (Hansen et al., 2020).

On November 21, 2020, FDA issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.


Synonyms

REGN10933


Supporting references

Link Tested on Impact factor Notes Publication date DB entry date
Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum
Antibody Biophysical assay Crystallization DNA In vitro Mixed substance Protein factor RNA Spike protein Spike variant
in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients and vaccinated adults; Vero cells; HEK293T/17-hACE2 cells; SARS-CoV-2 (Victoria, Alpha, Beta, and Delta); (HIV-1) SARS-CoV-2 Spike-pseudotyped virus (various variants) 41.58 (2020)

The antibody neutralized the Delta variant of SARS-CoV-2 in vitro. 

Jun/17/2021 Mar/11/2022
SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies
Antibody In vitro Mixed substance Peptide RNA Small molecule Spike protein
Caco-2 cells; Vero cells; Sera of vaccinated individuals; (VSV) SARS-CoV-2 Spike-pseudotyped virus (WT, B.1.1.7, B.1.351, ant P.1 variants) 38.64

Casirivimab displayed in vitro inhibition of SARS-CoV-2 Spike-pseudotyped virus infection for all tested emergent Spike variants (B.1.1.7, B.1.351, and P.1); however, the efficacy against B.1.351 and P.1 variants was lower.

Mar/20/2021 Apr/05/2021
Reduced neutralization of SARS-CoV-2 B.1.1.7 variant by convalescent and vaccine sera
Antibody Crystallization In vitro Mechanism Protein factor Spike protein Spike variant
in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients or vaccinated adults; Vero cells; SARS-CoV-2 (SARS-CoV-2/human/AUS/VIC01/2020 and SAR-CoV-2/B.1.1.7) 41.58 (2020)

The antibody displayed only a slight reduction in B.1.1.7 variant neutralization. 

Feb/18/2021 Mar/11/2022
Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies
Spike protein Antibody
Vero E6 cells 41.85 (2019)

REGN10987+REGN10933 antibody cocktail

Nov/23/2020 Nov/23/2020

Contradictory references

Link Tested on Impact factor Notes Publication date DB entry date
Efficacy of Antibodies and Antiviral Drugs against Covid-19 Omicron Variant
Spike protein Spike variant Protein factor In vitro Antibody
Vero E6-TMPRSS2 cells; SARS-CoV-2 strains (SARS-CoV-2/UT-NC002-1T/Human/2020/Tokyo, alpha, beta, gamma, delta, omicron) 91.25 (2020)

Casirivimab neutralized the omicron variant of SARS-CoV-2 with a very high FRNT50 only in vitro. 

Jan/26/2022 Feb/22/2022
A non-ACE2-blocking neutralizing antibody against Omicron-included SARS-CoV-2 variants
ACE2 Animal model Antibody Cryo-EM In vitro Mechanism Protein factor Spike protein Spike variant
Huh-7 cells; hACE2 mice; (VSV) SARS-CoV-2 Spike-pseudotyped virus (various strains) 18.19 (2020)

A significant loss of binding affinity of the antibody to Omicron SARS-CoV-2 Spike RBD was observed in vitro. 

Jan/25/2022 Feb/22/2022
Structural basis of SARS-CoV-2 Omicron immune evasion and receptor engagement
Antibody Biophysical assay Cryo-EM Crystallization In vitro Protein factor Spike protein Spike variant
In vitro 47.73 (2020)

The antibody’s affinity for B.1.1.529 (Omicron) variant Spike of SARS-CoV-2 was significantly reduced in vitro. 

Jan/25/2022 Feb/18/2022
An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies
Spike protein Spike variant Protein factor In vitro Antibody
Vero-TMPRSS2 cells; Vero-hACE2-TMPRSS2 cells; SARS-CoV-2 strains WA1/2020 and hCoV-19/USA/WI-WSLH-221686/2021 (Omicron) 53.44 (2020)

The antibody failed to neutralize B.1.1.529 (Omicron) variant of SARS-CoV-2 in vitro. 

Jan/19/2022 Feb/18/2022
Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies
Spike protein Spike variant Protein factor In vitro Antibody Screening
Huh-7 cells; SARS-CoV-2 Spike-pseudotyped viruses (various strains/mutations) 49.96 (2020)

The antibody was inefficient in Omicrom (SARS-Cov-2) neutralization in vitro. 

Dec/23/2021 Feb/22/2022
The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic
Spike protein Spike variant Protein factor Viral vector In vitro Antibody
293T cells; A549-ACE2 cells; BHK-21 cells; Vero cells; Huh-7 cells; Calu-3 cells; Caco-2 cells; (VSV) SARS-CoV-2 Spike pseudoviruses (B.1, Alpha, Beta, Gamma, Delta, or Omicron) 41.58 (2020)

The antibody was inefficient in neutralizing Omicron variant of SARS-CoV-2 and in combination with Imdevimab it was inefficient in preventing Spike-mediated cell entry in vitro. 

Dec/23/2021 Feb/18/2022
Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift
Spike protein Spike variant Protein factor In vitro Antibody
Vero E6-TMPRSS2 cells; SARS-CoV-2 Spike-pseudotyped viruses (including WA1/2020 D614G or Omicron) 49.96 (2020)

Lost its neutralization potency against Omicron variant of SARS-CoV-2 in vitro. 

Dec/23/2021 Feb/18/2022
The Impact on Infectivity and Neutralization Efficiency of SARS-CoV-2 Lineage B.1.351 Pseudovirus
Spike protein Spike variant In vitro Antibody In silico
in silico; 293T-ACE2 cells; SARS-CoV-2 Spike-psudotype virus variants. 3.82

The antibody had significantly reduced capacity to block SARS-CoV-2 Spike B.1.351 variant-pseudotyped infection in vitro.

Apr/07/2021 Aug/14/2021
Antibody evasion by the P.1 strain of SARS-CoV-2
Antibody Biophysical assay Crystallization DNA In vitro Mixed substance Protein factor RNA Spike protein Spike variant
in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients and vaccinated adults; Vero cells; SARS-CoV-2 (Victoria, Alpha, Beta, and Gamma) 41.58 (2020)

A significant loss in neutralization potency against Beta and Gamma strains of SARS-CoV-2 was observed. 

Mar/30/2021 Mar/11/2022
Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity
Antibody Biophysical assay Crystallization In silico In vitro Protein factor Spike protein Spike variant
Vero E6 cells; Vero E6-hACE2(-TMPRSS2) cells; (VSV) SARS-CoV-2 Spike-pseudotyped virus 41.58 (2020)

Significant decrease in Spike K417V and N439K/K417V neutralization was observed. 

Mar/04/2021 Feb/22/2022
Evidence of escape of SARS-CoV-2 variant B.1.351 from natural and vaccine-induced sera
Antibody Biophysical assay DNA In vitro Mixed substance Protein factor RNA Spike protein Spike variant
in vitro biophysical assay; plasma of COVID-19 (Beta strain) convalescent patients or vaccinated adults; Vero cells; SARS-CoV-2 (SARS-CoV-2/human/AUS/VIC01/2020 and SARS-CoV-2/B.1.351) 41.58 (2020)

SARS-CoV-2 Beta RBD binding and viral neutralization are severy impaired. 

Feb/23/2021 Mar/11/2022

Clinical trials

ID Title Status Phase Start date Completion date
NCT05181683 COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers Active, not recruiting Phase 1 Jan/07/2022 May/11/2022
NCT05157997 Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail Not yet recruiting Phase 1 Jan/01/2022 Jan/01/2025
NCT05092581 COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 Active, not recruiting Phase 1 Dec/16/2021 Jun/15/2022
NCT05195060 TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2 Recruiting Dec/14/2021 Jun/14/2024
NCT05205759 Non-inferiority Trial on Monoclonal Antibodies in COVID-19 Recruiting Phase 3 Dec/09/2021 Jul/01/2022
NCT05081388 COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease Active, not recruiting Phase 1|Phase 2 Nov/08/2021 Jul/08/2022
NCT05074433 A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults Active, not recruiting Phase 3 Oct/25/2021 May/25/2022
NCT05268601 COVID-19 and Disease Progression to the Severe Form: A Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 Recruiting Oct/14/2021 May/31/2024
NCT05149300 COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age Recruiting Phase 2 Sep/13/2021 Nov/17/2022
NCT04992273 COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age Active, not recruiting Phase 2 Sep/13/2021 Nov/17/2022
NCT04852978 COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers Active, not recruiting Phase 2 Apr/29/2021 Nov/25/2022
NCT04790786 UPMC OPTIMISE-C19 Trial, a COVID-19 Study Recruiting Phase 3 Mar/10/2021 Dec/01/2023
NCT04666441 COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection Completed Phase 2 Dec/15/2020 Sep/21/2021
NCT04840459 Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting Recruiting Phase 2 Nov/20/2020 Jan/31/2022
NCT04518410 ACTIV-2: A Study for Outpatients With COVID-19 Recruiting Phase 2|Phase 3 Aug/19/2020 Dec/31/2023
NCT04519437 Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19 Completed Phase 1 Jul/26/2020 Nov/22/2021
NCT04452318 COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay Completed Phase 3 Jul/13/2020 Oct/04/2021
NCT04425629 Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 Active, not recruiting Phase 3 Jun/16/2020 Jun/09/2022
NCT04426695 Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 Completed Phase 1|Phase 2 Jun/11/2020 Oct/22/2021
NCT04617535 Compassionate Use of REGN-COV2 for the Treatment of COVID-19 Available Jan/01/1970 Jan/01/1970