Abstract
To date, there is no severe acute respiratory syndrome coronavirus 2-(SARS-CoV-2)-specific prognostic biomarker available. We assessed whether SARS-CoV-2 cycle threshold (Ct) value at diagnosis could predict novel CoronaVirus Disease 2019 (COVID-19) severity, clinical manifestations, and six-month sequelae. Hospitalized and outpatient cases were randomly sampled from the diagnoses of March 2020 and data collected at 6 months by interview and from the regional database for COVID-19 emergency. Patients were stratified according to their RNA-dependent-RNA-polymerase Ct in the nasopharyngeal swab at diagnosis as follows: Group A ≤ 20.0, 20.0 < group B ≤ 28.0, and Group C > 28.0. Disease severity was classified according to a composite scale evaluating hospital admission, worst oxygen support required, and survival. Two hundred patients were included, 27.5% in Groups A and B both, 45.0% in Group C; 90% of patients were symptomatic and 63.7% were hospitalized. The median time from COVID-19 onset to swab collection was five days. Lethality, disease severity, type, and number of signs and symptoms, as well as six-month sequelae distributed inversely among the groups with respect to SARS-CoV-2 Ct. After controlling for confounding, SARS-CoV-2 Ct at diagnosis was still associated with COVID-19-related death (p = 0.023), disease severity (p = 0.023), number of signs and symptoms (p < 0.01), and presence of six-month sequelae (p < 0.01). Early quantification of SARS-CoV-2 may be a useful predictive marker to inform differential strategies of clinical management and resource allocation.
Highlights
Most cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are asymptomatic or experience self-limiting flu-like manifestations [1]
We assessed whether SARS-CoV-2 cycle threshold (Ct) value at diagnosis could predict novel CoronaVirus Disease 2019 (COVID-19) severity, clinical manifestations, and six-month sequelae
Among symptomatic hospitalized and outpatient COVID-19 cases at the beginning of the pandemic in Italy, we observed that disease severity, death, six-month sequelae, and the number of signs and symptoms at diagnosis distributed according to the amount of nasopharyngeal SARS-CoV-2 detected within the first week from disease onset, independently from other known determinants of COVID-19 severity
Summary
Most cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are asymptomatic or experience self-limiting flu-like manifestations [1]. In order to properly manage patients presenting with a newly discovered positive swab, several prognostic scores are under evaluation to predict in-hospital death and to discriminate between patients requiring hospital admission or not [3,4]. These scores rely upon variables that are extremely dependent on the timing of the evaluation along COVID-19 course, with the potential of sudden changes in a few hours. Reliance upon indicators providing better prognostic predictions would be critical in order to properly select patients requiring hospital admission, especially when exponentially increasing numbers of infections occur in a short time interval and hospitals become crowded
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