학술논문
Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19.
Document Type
Article
Author
Giganti, Mark J; Chew, Kara W; Eron, Joseph J; Li, Jonathan Z; Pinilla, Mauricio; Moser, Carlee; Javan, Arzhang Cyrus; Fischer, William A; Klekotka, Paul; Margolis, David; Wohl, David Alain; Coombs, Robert W; Daar, Eric S; Smith, Davey M; Currier, Judith S; Hughes, Michael D; Team, for the ACTIV-2/A5401 Study
Source
Subject
*SARS-CoV-2
*COVID-19
*CLINICAL trial registries
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Language
ISSN
0022-1899
Abstract
Background There is little information regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA as a predictor for clinical outcomes in outpatients with mild-to-moderate coronavirus disease 2019 (COVID-19). Methods Anterior nasal (AN) and plasma SARS-CoV-2 RNA data from 2115 nonhospitalized adults who received monoclonal antibodies (mAbs) or placebo in the ACTIV-2/A5401 trial were analyzed for associations with hospitalization or death. Results One hundred two participants were hospitalized or died through 28 days of follow-up. Higher day 0 (pretreatment) AN RNA was associated with increasing risk of hospitalization/death (risk ratio [RR], 1.24 per log10 copies/mL [95% confidence interval {CI}, 1.04–1.49]) among placebo recipients, ranging from 3% to 16% for <2 to ≥6 log10 copies/mL. Although only 1% had quantifiable levels, there was a similar trend across day 0 plasma RNA categories. Higher day 3 AN RNA was associated with subsequent hospitalization/death among placebo recipients (RR, 1.42 per log10 copies/mL [95% CI, 1.00–2.03]), but not mAb recipients (RR, 1.02 per log10 copies/mL [95% CI, 0.68–1.56]). The proportion of treatment effect (reduction in hospitalizations/deaths after day 3 for mAb vs placebo) explained by day 3 AN RNA was 8%. Conclusions SARS-CoV-2 RNA levels are predictive of hospitalization/death in the natural history setting, but AN RNA levels may not be a reliable surrogate marker of mAb treatment effect in COVID-19 trials. Clinical Trials Registration. NCT04518410. [ABSTRACT FROM AUTHOR]