May 11, 2022

Clinical outcomes of using regdanvimab in patients with mild to moderate COVID-19

In a recent study published in the Journal of Clinical Medicinea team of researchers evaluated the efficacy of regdanvimab on clinical outcomes in patients with mild to moderate coronavirus disease 2019 (COVID-19).

Study: Actual efficacy of regdanvimab on clinical outcomes in patients with mild to moderate COVID-19. Image Credit: plo/Shutterstock

Remdesivir received Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in May 2020 and June 2020, respectively. Since then, several therapeutic options, including antiviral agents, monoclonal antibodies (mAbs), etc., have been developed to improve outcomes in COVID-19. However, given the limited treatment options, remdesivir and dexamethasone remain the most potent drugs for treating hospitalized COVID-19 patients requiring supplemental oxygen.

Several previous studies have demonstrated that an mAb Regdanvimab reduces hospitalization in patients with mild to moderate COVID-19. Subsequently, in September 2021, it received approval from Korea’s Ministry of Food and Drug Safety for use in patients at risk of progression to a severe form of COVID-19. Although strongly recommended, data regarding its efficacy and safety in clinical practice are scarce.

About the study

In the present retrospective observational study, researchers recruited 152 patients admitted to the Armed Forces Hospital in Goyang, South Korea, between August and October 2021 who were diagnosed with mild to moderate COVID-19.

Of these 152 study participants, 89 patients receiving regdanvimab formed the regdanvimab group, while another 63 formed the non-regdanvimab group. The researchers compared the clinical outcomes of using regdanvimab in the two study groups, simultaneously studying its safety profile.

They used a linear mixed-effects model (LMEM) to test the effectiveness of regdanvimab use on symptom severity score (SSS) and laboratory test results. The researchers performed all laboratory tests on hospitalization days (HD) 1, 4, and 7 as part of routine clinical practice.; similarly, all patients completed a questionnaire asking for SSS on these HDs to help researchers monitor symptoms related to COVID-19. Patients in the regdanvimab group received a single intravenous infusion of 40 mg/kg over 60 minutes on hospitalization day (HD) 2.

Additionally, using a multivariate logistic regression model, the researchers calculated the odds ratio (OR) for additional treatment options, such as remdesivir, dexamethasone, and supplemental oxygen, specifically the effect of the use of regdanvimab on the initiation of these treatments. This model was adjusted for all possible clinical variables, including age, gender, Charlson Comorbidity Index (CCI) score, vaccination status, body mass index, body temperature of base, etc., and other variables between regdanvimab and non-regdanvimab groups.

Study results

Study results revealed that compared to the non-regdanvimab group, patients who received regdanvimab were older, had higher vaccination rate, CCI score, basal body temperature and pneumonia percentages. at admission.

As demonstrated by LMEM analysis, the use of regdanvimab showed no interactive effect on SSS and laboratory results; however, its use decreased the likelihood of requiring additional treatments. The need for dexamethasone, remdesivir, and supplemental oxygen after regdanvimab use was 85.8%, 90.3%, and 89.8%, respectively. Additionally, older age, male gender, obesity, elevated baseline body temperature, and presence of pneumonia at admission were associated with increased ORs for the use of these additional treatments.

This finding is consistent with previous studies; for example, in another study, the use of regdanvimab reduced deaths, oxygen supplementation and the need for intensive care by 83.1%. However, it is possible that since the age of the patients receiving regdanvimab was lower in the present study (46.9 versus 61), slightly fewer patients experienced severe disease progression.

In the regdanvimab and non-regdanvimab groups, LMEM analysis showed decreasing trends for creatinine, C-reactive protein, and lactate dehydrogenase. However, safety profiles based on laboratory tests showed no significant difference between these two groups.

Estimated SSS of respiratory and non-respiratory symptoms showed no association between regdanvimab use and symptom improvement, as demonstrated by the LMEM model.

Conclusion

Several other mAbs have shown promise as a treatment for mild to moderate COVID-19, including a combination of bamlanivimab plus etesevimab, the REGN-COV2 antibody cocktail, to name a few. Even a lab-designed mAb, sotrovimab, has been shown to reduce the need for hospitalization or death in COVID-19 patients by 85%, with no safety concerns.

The present study demonstrated the potential of using regdanvimab. It was well tolerated and decreased the likelihood of requiring remdesivir, dexamethasone, and oxygen therapy in mild to moderately ill COVID-19 patients. However, SSS was not significantly reduced by drug use. It should be noted here that a previous study showed an improvement in clinical symptoms in regdanvimab-treated animals that were infected with the D614G variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

In the future, studies using larger sample sizes and a machine learning-based prediction model or clustering algorithm may provide better insights into predicting which patients will specifically respond to regdanvimab treatment.


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