tetano
Editor, Senior Moderator
Clin Infect Dis
. 2024 Jul 17:ciae324.
doi: 10.1093/cid/ciae324. Online ahead of print. Severe Acute Respiratory Syndrome Coronavirus 2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With Coronavirus Disease 2019
Nikolaus Jilg[SUP] 1 [/SUP], Mark J Giganti[SUP] 2 [/SUP], Kara W Chew[SUP] 3 [/SUP], Katy Shaw-Saliba[SUP] 4 [/SUP], Justin Ritz[SUP] 2 [/SUP], Carlee Moser[SUP] 2 [/SUP], Teresa H Evering[SUP] 5 [/SUP], Eric S Daar[SUP] 6 [/SUP], Joseph J Eron[SUP] 7 [/SUP], Judith S Currier[SUP] 3 [/SUP], Michael D Hughes[SUP] 2 [/SUP], H Cliff Lane[SUP] 4 [/SUP], Robin Dewar[SUP] 8 [/SUP], Davey M Smith[SUP] 9 [/SUP], Jonathan Z Li[SUP] 1 [/SUP]
Affiliations
Background: Reliable biomarkers of coronavirus disease 2019 (COVID-19) outcomes are critically needed. We evaluated associations of spike antibody (Ab) and plasma nucleocapsid antigen (N Ag) with clinical outcomes in nonhospitalized persons with mild-to-moderate COVID-19.
Methods: Participants were nonhospitalized adults with mild-to-moderate COVID-19 enrolled in ACTIV-2 between January and July 2021 and randomized to placebo. We used quantitative assays for severe acute respiratory syndrome coronavirus 2 spike Ab and N Ag in blood and determined numbers of hospitalization/death events within 28 days and time to symptom improvement.
Results: Of 209 participants, 77 (37%) had quantifiable spike Ab and 139 (67%) quantifiable N Ag. Median age was 50 years; 111 (53%) were female, 182 (87%) White, and 105 (50%) Hispanic/Latino. Higher risk of hospitalization/death was seen with unquantifiable (22/132 [16.7%]) versus quantifiable (1/77 [1.3%]) spike Ab (risk ratio [RR], 12.83 [95% confidence interval {CI}, 1.76-93.34]) and quantifiable (22/139 [15.8%]) vs unquantifiable (1/70 [1.4%]) N Ag (RR, 11.08 [95% CI, 1.52-80.51]). Increasing risk of hospitalizations/deaths was seen with increasing N Ag levels. Time to symptom improvement was longer with unquantifiable versus quantifiable spike Ab (median, 14 [interquartile range {IQR}, 8 to >27] vs 8 [IQR, 4-22] days; adjusted hazard ratio [aHR], 0.66 [95% CI, .45-.96]) and with quantifiable versus unquantifiable N Ag (median, 12 [7 to >27] vs 10 [5-22] days; aHR, 0.79 [95% CI, .52-1.21]).
Conclusions: Absence of spike Ab and presence of plasma N Ag predicted hospitalization/death and delayed symptom improvement in COVID-19 outpatients.
Keywords: COVID-19; SARS-CoV-2; biomarker; nucleocapsid; spike antibody.
. 2024 Jul 17:ciae324.
doi: 10.1093/cid/ciae324. Online ahead of print. Severe Acute Respiratory Syndrome Coronavirus 2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With Coronavirus Disease 2019
Nikolaus Jilg[SUP] 1 [/SUP], Mark J Giganti[SUP] 2 [/SUP], Kara W Chew[SUP] 3 [/SUP], Katy Shaw-Saliba[SUP] 4 [/SUP], Justin Ritz[SUP] 2 [/SUP], Carlee Moser[SUP] 2 [/SUP], Teresa H Evering[SUP] 5 [/SUP], Eric S Daar[SUP] 6 [/SUP], Joseph J Eron[SUP] 7 [/SUP], Judith S Currier[SUP] 3 [/SUP], Michael D Hughes[SUP] 2 [/SUP], H Cliff Lane[SUP] 4 [/SUP], Robin Dewar[SUP] 8 [/SUP], Davey M Smith[SUP] 9 [/SUP], Jonathan Z Li[SUP] 1 [/SUP]
Affiliations
- PMID: 39018444
- DOI: 10.1093/cid/ciae324
Background: Reliable biomarkers of coronavirus disease 2019 (COVID-19) outcomes are critically needed. We evaluated associations of spike antibody (Ab) and plasma nucleocapsid antigen (N Ag) with clinical outcomes in nonhospitalized persons with mild-to-moderate COVID-19.
Methods: Participants were nonhospitalized adults with mild-to-moderate COVID-19 enrolled in ACTIV-2 between January and July 2021 and randomized to placebo. We used quantitative assays for severe acute respiratory syndrome coronavirus 2 spike Ab and N Ag in blood and determined numbers of hospitalization/death events within 28 days and time to symptom improvement.
Results: Of 209 participants, 77 (37%) had quantifiable spike Ab and 139 (67%) quantifiable N Ag. Median age was 50 years; 111 (53%) were female, 182 (87%) White, and 105 (50%) Hispanic/Latino. Higher risk of hospitalization/death was seen with unquantifiable (22/132 [16.7%]) versus quantifiable (1/77 [1.3%]) spike Ab (risk ratio [RR], 12.83 [95% confidence interval {CI}, 1.76-93.34]) and quantifiable (22/139 [15.8%]) vs unquantifiable (1/70 [1.4%]) N Ag (RR, 11.08 [95% CI, 1.52-80.51]). Increasing risk of hospitalizations/deaths was seen with increasing N Ag levels. Time to symptom improvement was longer with unquantifiable versus quantifiable spike Ab (median, 14 [interquartile range {IQR}, 8 to >27] vs 8 [IQR, 4-22] days; adjusted hazard ratio [aHR], 0.66 [95% CI, .45-.96]) and with quantifiable versus unquantifiable N Ag (median, 12 [7 to >27] vs 10 [5-22] days; aHR, 0.79 [95% CI, .52-1.21]).
Conclusions: Absence of spike Ab and presence of plasma N Ag predicted hospitalization/death and delayed symptom improvement in COVID-19 outpatients.
Keywords: COVID-19; SARS-CoV-2; biomarker; nucleocapsid; spike antibody.