Clinical outcomes in patients with severe respiratory failure due to novel coronavirus disease 2019 treated with non-invasive respiratory support: observational, prospective study

BACKGROUND: In the present study we aimed to analyze the response to non-invasive respiratory support in patients stratified with acute respiratory failure due to novel coronavirus disease. METHODS: A prospective, observational study was carried out in Hospital Universitario Rey Juan Carlos from February 1st to June 30th, 2020. The study was approved by the Ethics Committee of the Fundacion Jimenez Diaz. We included patients over 18 years of age with confirmed SARS-CoV-2 infection who required non-invasive respiratory support (N.=130). We classified patients included in the sample according to the three clinical scenarios established by the Spanish Respiratory Society. RESULTS: The mean age of the patients was 64.3 +/- 12.9 years;43.8% were older than 70, and the majority were male (N.=88;67.7%). Eighty percent of the study population (N.=104) presented comorbidities. The most used device was the continuous positive airway pressure (54.6%, N.=71). Non-invasive respiratory support-based treatment avoided Intensive Care Unit admission in 68% of the acute respiratory failure cases studied. Treatment-failure occurred in 43.8% of patients (37% clinical scenario 1, de-novo acute respiratory failure, P=0.04) and the overall rate of mortality was 36.2% (14.8% clinical scenario 1, P<0.00001). CONCLUSIONS: The used of non-invasive respiratory support was safe and clinically effective treatment (68% of ICU admissions prevented, lower rate of TF than that reported for other viral pneumonias, and a mortality rate of 14.8% within clinical scenario 1). Non-invasive respiratory support may be considered a first-line therapy for patients with severe COVID-19.

[Evaluation of the validity of Ag PANBIO-COVID19 in the diagnosis of SARS-CoV-2 infection in asymptomatic or mildly infected patients]. / Evaluación de la validez del Ag PANBIO-COVID19 de Abbott en el diagnóstico de la infección por SARS-CoV-2 en pacientes asintomáticos o con infección leve.

OBJECTIVE: To assess the validity of SARS-CoV-2 Antigen (Ag) detection for the diagnosis of SARS-CoV-2 infection in mildly infected or asymptomatic patients. METHODS: Observational study to evaluate diagnostic tests. Non-hospitalized patients with indication for diagnostic testing for SARS-CoV-2 infection were included. The diagnostic test to be evaluated was the determination of Ag and as a reference standard to determine the presence of viral RNA the RT-PCR was used. RESULTS: A total of 494 patients were included. Of these 71.5% (353/494) had symptoms and 28.5% (141/494) were asymptomatic (presurgery screening (35/494) and confirmed case-contact (106/494). The overall sensitivity of the Ag test was 61.1% and the specificity was 99.7%. The sensitivity and specificity in the asymptomatic group were 40% and 100% respectively, and in the symptomatic group 63.5% and 99.6% respectively. In turn, the sensitivity and specificity in the group of symptomatic patients varied according to the time of symptom evolution: in patients with recent symptoms, they were 71.4% and 99.6% respectively, while in patients with symptoms of more than 5 days of evolution, they were 26.7% and 100% respectively. In all groups studied, the presence of antigen is associated with a high viral load (Ct<30 cycles). CONCLUSIONS: The use of Ag detection test is not indicated for the diagnosis of SARS-CoV-2 infection in asymptomatic patients or with symptoms of more than 5 days of evolution, but it could be useful in patients with symptoms of 1-5 days of evolution.