Your browser doesn't support javascript.
Association between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death for Non-Hospitalized Adults with Mild-to-Moderate COVID-19
Open Forum Infectious Diseases ; 9(Supplement 2):S44, 2022.
Article in English | EMBASE | ID: covidwho-2189512
ABSTRACT
Background. Data are currently limited on the performance of SARS-CoV-2 RNA levels as predictors or surrogate markers for clinical outcomes in outpatients with mild-to-moderate COVID-19. Methods. This exploratory analysis used data from 2205 non-hospitalized adults who enrolled between August 2020 and July 2021 and participated in placebocontrolled evaluations of two monoclonal antibody (mAb) agents (bamlanivimab [n=317] or amubarvimab/romlusevimab [n=837]), and an open-label cohort of bamlanivimab recipients [n=1051] as part of the ACTIV-2/A5401 platform trial. SARS-CoV-2 RNA levels were measured in anterior nasal (AN) swabs and plasma at day 0 (pre-treatment) and AN at day 3. We fit regression models to estimate the association between RNA level or detection and subsequent hospitalization/death within 28 days of enrollment. Results. One-hundred four participants (53/571 [9%] on placebo and 51/ 1634 [3%] on mAb) died or were hospitalized through day 28. Median AN RNA levels were lower at day 3 compared to day 0 in both placebo (2.5 vs 4.0 log10 copies/mL [cp/mL]) and mAb (2.3 vs 4.9) groups. For placebo recipients, higher Day 0 AN RNA was associated with an increasing risk of hospitalization/ death, ranging from 3% to 16% for < 2 and >= 6 log10 cp/mL, respectively. Although only 1% had quantifiable plasma SARS-CoV-2 RNA, there was a similar trend for day 0 plasma RNA 5% hospitalizations/death for undetectable RNA, 16% for detectable but not quantifiable RNA, and 80% for >= 2 log10 cp/mL. Among 485 placebo recipients with days 0 and 3 ANRNA results, the risk of subsequent hospitalization/death was highest among those with >= 5.0 log10 cp/mL at both days [8/78;10%] and lowest for those with unquantifiable levels at both days [0/124;0%]. Higher AN RNA at day 3 (adjusted for day 0 RNA) was associated with subsequent hospitalization/death among placebo recipients (relative risk (RR) 1.4 per log10 cp/mL;95%CI 1.0, 2.1), but not mAb recipients (RR 1.0;95%CI 0.7, 1.6). Conclusion. These findings suggest that AN and plasma SARS-CoV-2 RNA levels are predictive of hospitalization/death in the natural history setting. However, different associations for mAb and placebo recipients raises concerns for using AN RNA as a surrogate for clinical outcomes in mAb trials. (Table Presented).
Keywords

Full text: Available Collection: Databases of international organizations Database: EMBASE Language: English Journal: Open Forum Infectious Diseases Year: 2022 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: Databases of international organizations Database: EMBASE Language: English Journal: Open Forum Infectious Diseases Year: 2022 Document Type: Article