Other substances

Regdanvimab

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

Phase of research

Authorized

How it helps

Antiviral

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Regdanvimab is a human monoclonal antibody (reformatted into IgG). It was identified using phage display for its affinity to SARS-CoV-2 Spike RBD. It neutralizes D614G variant of SARS-CoV-2 in vitro (Kim et al, 2021).

As it has been demonstrated that regdanvimab reduces the risk of progression into a severe disease, it has been authorized for the use in mild or moderate COVID-19 patients at increased risk of disease progression by EMA in the EU.

Regdanvimab on DrugBank
Regdanvimab on Wikipedia

Synonyms

CT-P59

Marketed as

REGKINORA

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Real-World Efficacy of Regdanvimab on Clinical Outcomes in Patients with Mild to Moderate COVID-19 Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study	Patients	4.24	The treatment was safe and reduced the need for the use of remdesivir, dexamethasone and supplemental oxygen. Symptom alleviation was not observed, however. Sample size: 89 + 63 control. Dosage: A single infusion of 40 mg/kg of body weight.	Mar/04/2022
A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Spike protein Biophysical assay Protein factor In vitro Antibody	Vero E6 cells; SARS-CoV-2 strains BetaCoV/Korea/KCDC03/2020 and hCoV-19/South Korea/KUMC17/2020	14.92	The antibody neutralized SARS-CoV-2 D614G variant in vitro with an IC50 of 5.7 ng/ml.	Jan/12/2021
Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease Spike protein Protein factor Antibody Mild severity Cohort study	High-risk patients	7.56	The treatment was associated with a lower risk of progression into a severe disease, even after propensity score-matching. Sample size: 234 + 544 control. Main outcome: Oxygen supplementation and disease progression.	Nov/23/2021
Regdanvimab in patients with mild-to-moderate SARS-CoV-2 infection: A propensity score–matched retrospective cohort study Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study	Patients	4.93	The treatment was safe. It was associated with a lower risk of progression into a severe disease, even after propensity score-matching. The duration of supplemental oxygen use and hospitalization were shorter, as well. Sample size: 113 + 161 control (after propensity score-matching). Main outcome: Disease progression or death by the day 28.	Feb/04/2022
Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: .............. Spike protein Protein factor Phase I clinical trial Randomized controlled double-blind trial Antibody Mild severity	Healthy individuals; patients	3.39	The formulation showed a good safety profile. Some observations suggested its efficacy, as well (e. g. a shorter mean time to clinical recovery compared to placebo treatment). Sample size: Trial A: four dosing groups of 6 + a single placebo group of 8. Trial B: three dosing groups of 5 + a single placebo group of 3. Dosage: A single (ascending) dose of 10, 20, 40, or 80 mg/kg. Main outcome: Safety and tolerability.	Aug/22/2021
Haploidentical CD3+ TCR αβ/CD19+–depleted HSCT for MHC class II deficiency and persistent SARS-CoV-2 pneumonitis Spike protein RdRpol Cell-based therapy Adoptive cell therapy Protein factor Children Small molecule Case report Antibody Mixed substance	An immunodeficient juvenile patient	10.79	In a juvenile patient experiencing severe immunodeficiency after hematopoietic stem cell transplantation and COVID-19, decrease in viral load, expansion of CD3 lymphocytes and clinical/radiological improvement were observed after treatment with CD45RO+ memory T cells, remdesivir, and regdanvimab. Sample size: 1. Dosage: 40 mg/kg.	Jan/18/2023

AI-suggested references

Link	Publication date
Changes in Shooting Incidence in Philadelphia, Pennsylvania, Between March and November 2020.	Feb/02/2022
Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study	Apr/04/2022
Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2	Aug/23/2021
Regdanvimab: First Approval	Feb/06/2022
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.	Sep/02/2021
Clinical Effectiveness of Regdanvimab Treatment for Mild to Moderate COVID-19: A Retrospective Cohort Study.	May/16/2022
In Silico Analyses on the Comparative Potential of Therapeutic Human Monoclonal Antibodies Against Newly Emerged SARS-CoV-2 Variants Bearing Mutant Spike Protein	Jan/10/2022
Perspectives on passive antibody therapy and peptide-based vaccines against emerging pathogens like SARS-CoV-2.	Jun/02/2021
A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein	Jan/12/2021
Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant.	Jun/07/2021
Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline	Dec/16/2020
Effectiveness of Regdanvimab at Preventing the Need for Oxygen Therapy in Patients with Mild-to-Moderate COVID-19: A Retrospective Cohort Study	Jul/04/2022
The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study	Mar/18/2022
Omicron: A Heavily Mutated SARS-CoV-2 Variant Exhibits Stronger Binding to ACE2 and Potently Escapes Approved COVID-19 Therapeutic Antibodies	Dec/28/2021
Fruitful Neutralizing Antibody Pipeline Brings Hope To Defeat SARS-Cov-2	Jul/31/2020
In-Silico Analysis of Monoclonal Antibodies against SARS-CoV-2 Omicron	Feb/14/2022
Regdanvimab in patients with mild-to-moderate SARS-CoV-2 infection: A propensity score-matched retrospective cohort study	Feb/04/2022
Real World Experience with Regdanvimab Treatment of Mild-to-Moderate Coronavirus Disease-19 in a COVID-19 Designated Hospital of Korea	Dec/16/2020
The in vitro and in vivo efficacy of CT-P59 against Gamma, Delta and its associated variants of SARS-CoV-2	Jan/08/2022

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04602000	To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19	Completed	Phase 2\|Phase 3	Sep/25/2020	Oct/20/2021
Alternative id - CT-P59 3.2 Interventions - Biological: CT-P59/Placebo Study type - Interventional Study results - No Results Available Locations - Chungnam National University Hospital, Daejeon, Jung-gu, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 1642 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II)\|Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II)\|Time to clinical recovery for Part 1 (Phase II)\|Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 1 (Phase II)\|Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection in high-risk patients for Part 2 (Phase III)\|Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection for Part 1 and Part 2\|Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection for Part 1 and Part 2\|Proportion of patients with all-cause mortality for Part 1 and Part 2\|Time to clinical recovery for Part 1 and Part 2\|Duration of fever for Part 1 and Part 2\|Proportion of patients with hospital admission due to SARS-CoV-2 infection for Part 1 and Part 2\|Proportion of mechanical ventilation due to SARS-CoV-2 infection for Part 1 and Part 2\|Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 and Part 2\|Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture for Part 1 and Part 2\|Proportion of patients requiring rescue therapy due to SARS-CoV-2 infection for Part 1 and Part 2\|Time to national early warning score 2 (NEWS2) of 0 for Part 1 and Part 2\|Scores of other known SARS-CoV-2 infection symptoms such as vomiting, diarrhea, loss of taste or smell for Part 1 and Part 2\|Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 2\|Time to clinical recovery in high-risk patients for Part 2
NCT04593641	This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)	Active, not recruiting	Phase 1	Sep/04/2020	Dec/23/2020
Alternative id - CT-P59 1.2\|2020-003165-19 Interventions - Biological: CT-P59 Study type - Interventional Study results - No Results Available Locations - Incheon Medical Center, Incheon, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 18 Age - 18 Years to 60 Years (Adult) Outcome measures - To evaluate the preliminary safety and tolerability of CT-P59 up to Day 14 of the last enrolled subject\|To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59\|To evaluate the efficacy of CT-P59\|To evaluate the Pharmacokinetics of CT-P59
NCT04525079	To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects	Completed	Phase 1	Jul/18/2020	Nov/05/2020
Alternative id - CT-P59 1.1\|2020-003065-19 Interventions - Drug: CT-P59\|Drug: Placebo Study type - Interventional Study results - Has Results Locations - Chungnam National University Hospital, Daejeon, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Screening Enrollment - 32 Age - 19 Years to 55 Years (Adult) Outcome measures - Preliminary Safety and Tolerability of CT-P59\|Additional Safety of CT-P59 Including Immunogenicity\|Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last\|Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose\|Pharmacokinetic (PK) Parameter: Cmax\|Pharmacokinetic (PK) Parameter: Cmax/Dose\|Pharmacokinetic (PK) Parameter: Tmax\|Pharmacokinetic (PK) Parameter: t1/2\|Pharmacokinetic (PK) Parameter: %AUCext\|Pharmacokinetic (PK) Parameter: λz\|Pharmacokinetic (PK) Parameter: CL\|Pharmacokinetic (PK) Parameter: Vz

Export (.csv)