COVID-19 News

Using Active Surveillance to Identify Monoclonal Antibody Candidates Among COVID-19–Positive Veterans in the Atlanta VA Health Care System 

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Background: Strategies for optimizing identification and outreach to potential candidates for monoclonal antibody (Mab) therapy for COVID-19 are not clear. Using a centralized, active surveillance system, the Atlanta Veterans Affairs Health Care System (AVAHCS) infectious disease (ID) team identified candidates for Mab infusion and provided treatment.

Observations: As part of a quality improvement project from December 28, 2020, to August 31, 2021, a clinical team consisting of ID pharmacists and physicians reviewed each outpatient with a positive COVID-19 polymerase chain reaction test daily at the AVAHCS. The clinical team used Emergency Use Authorization (EUA) criteria to determine eligibility. Eligible patients were contacted on the same day of review via telephone to confirm eligibility and obtain verbal consent. Telehealth follow-up occurred on day 1 and day 7 postinfusion to assess for adverse events. In total, 2028 patients with COVID-19 were identified; 289 patients (14%) were eligible, and 132 (46%) received Mab therapy. Similar to AVAHCS demographics, a majority of those who received Mab therapy were non-Hispanic Black patients (65%). The most common comorbidities were hypertension (59%) and diabetes (37%). The median time from symptom onset to positive COVID-19 polymerase chain reaction (PCR) test result was 6 days (range, 0-9), and the median time from positive COVID-19 PCR test result to Mab infusion was 2 days (range, 0-8). Twelve patients (9%) required hospitalization for worsening COVID-19 symptoms postinfusion. No deaths occurred.

Conclusions: Combining laboratory surveillance and active screening led to high uptake of Mab therapy and minimized delay from symptom onset to Mab infusion, thereby optimizing outpatient treatment of COVID-19. This approach also successfully screened and treated Black patients in the AVAHCS population.


 

References

Early in the COVID-19 pandemic, monoclonal antibody (Mab) therapy was the only outpatient therapy for patients with COVID-19 experiencing mild-to-moderate symptoms. The Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE-1) and the REGN-COV2 (Regeneron) clinical trials found participants treated with Mab had a shorter duration of symptoms and fewer hospitalizations compared with those receiving placebo.1,2 Mab therapy was most efficacious early in the disease course, and the initial US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of Mab therapies required use within 10 days of symptom onset.3

The impact of the COVID-19 pandemic has been felt disproportionately among marginalized racial and ethnic groups in the US. The COVID-19 Associated Hospitalization Surveillance Network found that non-Hispanic Black persons have significantly higher rates of hospitalization and death by COVID-19 compared with White persons.4-7 However, marginalized groups are underrepresented in the receipt of therapeutic agents for COVID-19. From March 2020 through August 2021, the mean monthly Mab use among Black patients (2.8%) was lower compared with White patients (4.0%), and Black patients received Mab 22.4% less often than White patients.7

The Mab clinical trials BLAZE-1 and REGN-COV2 study populations consisted of > 80% White participants.1,2 Receipt of COVID-19 outpatient treatments may not align with the disease burden in marginalized racial and ethnic groups, leading to health disparities. Although not exhaustive, reasons for these disparities include patient, health care practitioner, and systems-level issues: patient awareness, trust, and engagement with the health care system; health care practitioner awareness and advocacy to pursue COVID-19 treatment for the patient; and health care capacity to provide the medication and service.7

Here, we describe a novel, quality improvement initiative at the Atlanta Veterans Affairs Health Care System (AVAHCS) in Georgia that paired a proactive laboratory-based surveillance strategy to identify and engage veterans for Mab. By centralizing the surveillance and outreach process, we sought to reduce barriers to the Mab referral process and optimize access to life-saving medication.

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