ABSTRACT
Background: Providing monoclonal antibody therapy infusions requires challenging logistics, resources, and technology, hindering availability across the United States. Early identification and treatment of COVID-positive patients can reduce hospitalizations. Objective: This study aimed to describe the referral, selection process, and deployment of outpatient monoclonal infusion clinics, as well as the impact of monoclonal antibody therapy in COVID-positive patients on the rate of emergency department (ED) visits and hospitalization. Methods: This is a retrospective cohort study that used screening of all COVID-positive ambulatory patients using a unique scoring rubric embedded in the emergency medical response for appropriateness for therapy between November 2020 and January 2021. Participants included all outpatients testing positive for COVID-19 were screened, and those eligible were referred for treatment with bamlanivimab. Of the 443 patients referred for treatment, 252 patients were treated with bamlanivimab compared with 191 patients who declined treatment. Patients were treated either in 1 of the 2 outpatient infusion centers (74%) or the ED (26%.) Results: Of 443 patients with positive COVID-19 diagnoses who were eligible for treatment based on a risk assessment rubric, 252 received bamlanivimab. There was a significant reduction in hospitalization of the treatment versus control group (6.7% vs 13.6%, P < 0.05). No significant differences were noted in risk score at screening, ED visits after infusion, days of symptom onset at screening or infusion, or death. Conclusions and Relevance: The efficacy of monoclonal antibody therapy on reducing hospitalization was demonstrated. Rapid development of screening technology, scheduling and operational logistics, and physical space can overcome the challenges in the current environment.
ABSTRACT
Background Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe coronavirus disease in 2019 (COVID-19). COVID-19 convalescent plasma (CCP) has been proposed as a specific therapy for patients with COVID-19. Our goal is to assess changes in oxygenation and inflammatory markers in patients after receiving CCP. Methods This is a retrospective, health system-based, a case-control study comparing hospitalized patients with COVID-19 who received CCP and were discharged (survivors) to patients who died after receiving CCP (non-survivors). We analyzed the severity of ARDS, oxygenation, and inflammatory markers of 295 patients, comparing 202 survivors to 93 non-survivors with COVID-19 who received CCP. Demographic information and laboratory data were collected on the day of the admission (initial), the day of the plasma infusion (D1), and post-infusion days 3, 7, 15, and 30 (when available). Results Survivors were younger (52.48 y versus 64.02 y;p<0.001) with no pre-existing conditions (25.2% versus 13.9%;p=0.03) compared to non-survivors. Severe ARDS (PaO2/FiO2 <100) was predictive of increased mortality after CCP in non-survivors (p<0.001). Survivors with mild (20%) or moderate (46%) ARDS on D1 had a 54% resolution of ARDS on D7 after CCP (p<0.001). After 72 hours of transfusion, supplemental oxygen requirements decreased by 63% of the survivors, compared to 33% of non-survivors (p<0.001). Inflammatory markers, including white blood cells, absolute neutrophils, platelets, C-reactive protein (CRP), lactate dehydrogenase (LDH), and creatinine, improved within three days in survivors after CCP (p<0.05). Baseline findings associated with a poor prognosis on D1 include a lower platelet count (219.02 versus 281.64, p<0.001), higher blood urea nitrogen (BUN) (35.41 versus 21.48, p<0.001), higher creatinine (2.24 versus 1.26, p<0.001), higher D-dimer (5.88 versus 2.46, p<0.001) and elevated lactate dehydrogenase (LDH) (698.3 versus 464.51, p<0.001) when comparing non-survivors to survivors, respectively. After 72 hours post-transfusion, the following changes were remarkable: normalization of creatinine with a mean of 1.07 in survivors versus 1.92 in non-survivors (p<0.001), a significant decrease in CRP improving from 129.27 to 84.25 in survivors versus 139.11 to 130.0 in non-survivors (p<0.001), and lower lactate dehydrogenase (LDH) in survivors (459.47) versus non-survivors (674.56, p<0.001). Conclusion In this retrospective, health system-based, case-control study, we found that the improvement in oxygenation, resolution of ARDS, and reduced inflammatory markers are seen in survivor patients after early COVID-19 convalescent plasma transfusion. These parameters can be used to assess response to COVID-19 convalescent plasma after 72 hours of the transfusion and could help physicians in the decision-making when administering CCP, especially if resources are scarce. [Formula presented] Disclosures: No relevant conflicts of interest to declare.