SIGNIFICANCE OF ELEVATED SARS-CoV-2 ANTIGEN LEVELS DURING EARLY HOSPITALIZATION
Topics in Antiviral Medicine
; 31(2):288-289, 2023.
Article
in English
| EMBASE | ID: covidwho-2315663
ABSTRACT
Background:
Patients hospitalized with COVID-19 randomized to standard of care (SoC) plus placebo or SoC plus monoclonal antibody (mAb)[bamlanivimab, sotrovimab, amburvimab-romlusevimab, or tixagevimab-cilgagavimab] as separate arms of TICO/ACTIV-3 did not show differences in the time to sustained recovery through day 90. Combining these cohorts, we assessed if early changes in plasma nucleocapsid antigen(pNA) were associated with clinical outcomes. Method(s) TICO/ACTIV-3 enrolled 2,254 patients between 8/5/2020 to 9/30/2021. We used the Quanterix assay to measure pNA of stored samples. We selected those with pNA in the top quartile at baseline through day 5 and examined the association with baseline factors and clinical outcomes through day 90 using regression methods (proportional odds logistic, Cox proportional hazard, and Fine-Gray competing risk models as appropriate). Result(s) Of the 2,149 patients with a baseline value and at least one measurement of pNA on Days 1-5, we found a median age 57 (IQR 46-68), 58% male, 64.9% with one or more co-morbidities, 82.1% unvaccinated, 37.6% with delta variant, median symptom duration 8 days (IQR 6-10), and 9.2% on high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV). Participants with pNA in the top quartile (>4693.5 ng/L at baseline and >29.9 ng/L at day 5) occurred more commonly among those with baseline renal impairment [OR 4.1 (95% CI 2.8 to 5.9)], and pulmonary severity of illness requiring oxygen of < 4 L/min [OR 2.2 (95 %CI 1.5 to 3.4)], >4 L/min [OR 4.9(95% CI 3.3, to 7.4)], and HFNO/NIV [OR 5.3 (95% CI 3.1 to 9.0)] compared to those not using supplemental oxygen at study entry. Patients with positive anti-spike antibody at baseline had lower odds of persistently high pNA [OR 0.15 (95%CI 0.10 to 0.20)]. Participants with pNA levels in the top quartile through day 5 were associated with increased risk of all-cause day 90 mortality [HR 4.4 (95% CI 3.2, 5.9)], and reduced incidence of sustained recovery through day 90 [RRR 0.40 (95% CI 0.35 to 0.45)]. Conclusion(s) PNA levels in the top quartile over the first 5 days were associated with elevated risk for death and reduced recovery. This group includes those with renal impairment, use of oxygen for COVID-19, and negative for anti-spike antibody. Top quartile pNA in early infection identified subjects on lower level of oxygen that were high risk for poor outcomes potentially identifying those that would benefit from additional treatment. (Figure Presented).
adult; clinical outcome; comorbidity; conference abstract; controlled study; coronavirus disease 2019; drug therapy; female; hospitalization; human; human tissue; incidence; kidney disease; major clinical study; male; middle aged; mortality; nonhuman; noninvasive ventilation; outcome assessment; risk model; Severe acute respiratory syndrome coronavirus 2; spike; virus nucleocapsid; antigen; oxygen
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Collection:
Databases of international organizations
Database:
EMBASE
Language:
English
Journal:
Topics in Antiviral Medicine
Year:
2023
Document Type:
Article
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