Abstract
Introduction
Several clinical trials have demonstrated that REGEN-COV (casirivimab and imdevimab) decreases the risk of hospitalization and death among COVID-19 patients. However, these trials did not evaluate the optimal timing of its administration, and evidence is limited regarding the relationship between the timing of administration and progression to severe COVID-19 among patients who receive REGEN-COV in a real-world setting. We examined the association between the timing of REGEN-COV administration and progression to severe COVID-19 among patients who received REGEN-COV in Japan.
Methods
We included a total of 342 COVID-19 patients (37 hospitals) who received REGEN-COV between July 19 and September 30, 2021. We calculated the difference between the date of symptom onset and the date of administration as an indicator of the timing of REGEN-COV administration and determined progression to severe COVID-19 after REGEN-COV administration. We conducted a logistic regression analysis, adjusting for potential confounders.
Results
The proportion of cases progressing to severe COVID-19 increased daily from symptom onset and sharply increased from day 5 of onset. The early administration (days 0–4) decreased the risk of progression to severity compared with late administration (after day 5), with an adjusted odds ratio of 0.29 (95% confidence interval: 0.11–0.56).
Conclusions
The early administration of REGEN-COV was associated with a decreased risk of progression to severe COVID-19 when the delta variant was dominant. The present epidemiological findings indicate that this monoclonal antibody therapy should be implemented very early in the clinical course probably even for emerging variants such as omicron BA.2.
【저자키워드】 COVID-19, Epidemiology, REGEN-COV, severe disease, Timing of administration, 【초록키워드】 clinical trial, therapy, Trial, severe COVID-19, Hospitalization, severity, monoclonal antibody, variant, risk, progression, hospitals, Clinical course, Patient, death, Japan, COVID-19 patients, association, Evidence, administration, COVID-19 patient, symptom onset, adjusted odds ratio, Logistic regression analysis, confounders, early administration, dominant, decrease, Result, evaluate, examined, proportion, conducted, calculated, demonstrated, receive, epidemiological finding, the timing, 【제목키워드】 severe COVID-19, progression, administration,