{"doi":"10.17615/jgjx-bf38","title":"Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19","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.","journal":"UNC Libraries","year":2025,"id":561542,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":0.0,"corpus_rank":10062,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":true,"is_dataset_confidence":0.6296,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1006550,"name":"ACTIV- A Study Team","orcid":null,"position":1,"is_corresponding":false},{"id":109932,"name":"William A. Fischer","orcid":"0000-0002-4900-098X","position":2,"is_corresponding":false},{"id":108340,"name":"Jonathan Z. Li","orcid":"0000-0001-9914-9662","position":3,"is_corresponding":false},{"id":315361,"name":"Kara W Chew","orcid":"0000-0003-4865-4348","position":4,"is_corresponding":false},{"id":806068,"name":"Arzhang Cyrus Javan","orcid":null,"position":5,"is_corresponding":false},{"id":474421,"name":"Mauricio Pinilla","orcid":null,"position":6,"is_corresponding":false},{"id":387866,"name":"Mark J Giganti","orcid":"0000-0003-2255-9756","position":7,"is_corresponding":false},{"id":36878,"name":"Davey M. Smith","orcid":"0000-0003-3603-1733","position":8,"is_corresponding":false},{"id":396976,"name":"Judith S. Currier","orcid":"0000-0003-4279-4737","position":9,"is_corresponding":false},{"id":419481,"name":"Carlee Moser","orcid":"0000-0001-5601-9112","position":10,"is_corresponding":false},{"id":65752,"name":"Michael D. Hughes","orcid":"0000-0001-8562-2316","position":11,"is_corresponding":false},{"id":351140,"name":"Eric S. Daar","orcid":"0000-0003-1880-7331","position":12,"is_corresponding":false},{"id":65748,"name":"Robert W. Coombs","orcid":"0000-0003-2709-0512","position":13,"is_corresponding":false},{"id":340150,"name":"David A. Wohl","orcid":"0000-0002-7764-0212","position":14,"is_corresponding":false},{"id":105520,"name":"David M. Margolis","orcid":"0000-0001-5714-0002","position":15,"is_corresponding":false},{"id":249713,"name":"Joseph J. Eron","orcid":"0000-0002-4938-0644","position":16,"is_corresponding":false},{"id":647421,"name":"Paul Klekotka","orcid":null,"position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T02:55:58.259104Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}