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Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19
- 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;
- Hosey, Lara;
- Roa, Jhoanna;
- Patel, Nilam;
- Greninger, Alexander;
- Degli-Angeli, Emily;
- Goecker, Erin;
- Daza, Glenda;
- Harb, Socorro;
- Dragavon, Joan;
- Aldrovandi, Grace;
- Murtaugh, William;
- Science, Frontier;
- Cooper, Marlene;
- Gutzman, Howard;
- Knowles, Kevin;
- Bowman, Rachel;
- Erhardt, Bill;
- Waring, Lorraine;
- Hessinger, Diane;
- Adams, Stacey
- et al.
Published Web Location
https://doi.org/10.1093/infdis/jiad287Abstract
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.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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