Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.

BACKGROUND: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. METHODS: GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. RESULTS: After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34-3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22-.68, P = .001). CONCLUSIONS: In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. CLINICAL TRIALS REGISTRATION: NCT04292899 and EUPAS34303.

[Validation of the Spanish version of the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Its usefulness and that of FEV1/FEV6 for the diagnosis of COPD]. / Validación de la versión traducida del Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Su utilidad y la del FEV1/FEV6 para el diagnóstico de enfermedad pulmonar obstructiva crónica.

BACKGROUND AND OBJECTIVES: The chronic obstructive pulmonary disease (COPD) is a highly undiagnosed disease. The use of short screening questionnaires designed to detect chronic airflow obstruction may help to the early diagnosis of COPD. PATIENTS AND METHOD: This was an observational, cross-sectional epidemiological study aimed to validate the translated into Spanish version of the COPD-PS questionnaire. Socio-demographic and clinical data of participants were collected, as well as their answers to the COPD-PS and EQ-5D questionnaires. The ratio FEV(1)/FEV(6) was measured with the COPD-6 device. The psychometric properties of the questionnaire and the diagnostic yield of the FEV(1)/FEV(6) ratio were analysed, both referred to the gold standard of post-bronchodilator FEV(1)/FVC < 0.7. RESULTS: Ten primary care centers participated in the study and included 94 controls and 79 cases with chronic airflow obstruction. Questionnaire characteristics were: feasibility, 2.3% of participants did not answer at least one item; mean time to fill the questionnaire was 47.7 seconds; 4.7% of individuals had a 0 score. Validity, moderate correlation with EQ-5D scores and moderate-high with FEV(1); the scores of COPD-PS were related to all parameters associated with COPD. A cut off of 4 units had the best sensitivity/specificity ratio and correctly classified 78% of participants. For the FEV(1)/FEV(6) ratio, a cut off of 0.75 correctly classified 85% of individuals. CONCLUSIONS: The COPD-PS questionnaire demonstrated good psychometric properties. A cut off score of 4 has excellent predictive value. A ratio of 0.75 in the FEV(1)/FEV(6) provides an excellent correlation with the ratio FEV(1)/FVC and is useful for the identification of individuals with chronic airflow obstruction.