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Abstract Introduction : The COVID-19 vaccine became an effec tive instrument to prevent severe SARS-CoV-2 infections. However, 5% of vaccinated patients will have moderate or severe disease. Objective: to compare mortality and days between the symptom onset to the peak disease severity, in vaccinated vs. unvaccinated COVID-19 hos pitalized patients. Methods : Retrospective observational study in 36 hospitals in Argentina. COVID-19 adults admitted to general wards between January 1, 2021, and May 31, 2022 were included. Days between symptoms onset to peak of severity were compared between vaccinated vs. unvaccinated patients with Cox regression, adjusted by Propensity Score Matching (PSM). Results in patients with one and two doses were also compared. Results : A total of 3663 patients were included (3001 [81.9%] unvaccinated and 662 [18%] vaccinated). Time from symptom onset to peak severity was 7 days (IQR 4-12) vs. 7 days (IQR 4-11) in unvaccinated and vacci nated. In crude Cox regression analysis and matched population, no significant differences were observed. Regarding mortality, a Risk Ratio (RR) of 1.51 (IC95% 1.29-1.77) was observed in vaccinated patients, but in the PSM cohort, the RR was 0.73 (IC95% 0.60-0.88). RR in patients with one COVID-19 vaccine dose in PSM adjusted population was 0.7 (IC95% 0.45-1.03), and with two doses 0.6 (IC95% 0.46-0.79). Discussion : The time elapsed between the onset of COVID-19 symptoms to the highest severity was simi lar in vaccinated and unvaccinated patients. However, hospitalized vaccinated patients had a lower risk of mortality than unvaccinated patients.
Resumen Introducción : A pesar de la eficacia de la vacuna contra el COVID-19 el 5% de los pacientes vacunados presentaran una enfermedad moderada o grave. El ob jetivo del presente estudio fue comparar los días entre el inicio de los síntomas y la gravedad máxima de la enfermedad, en pacientes con COVID-19 vacunados vs. no vacunados. Métodos : Estudio observacional retrospectivo en 36 hospitales de Argentina. Se incluyeron adultos con CO VID-19 hospitalizados entre el 1/01/2021 y 31/5/2022. Se recolectaron datos demográficos, comorbilidades y progresión clínica de la enfermedad. Se compararon los días entre el inicio de los síntomas y el pico de gravedad entre vacunados y no vacunados mediante regresión de Cox, ajustada por emparejamiento por Propensity Score Matching (PSM). En un análisis de subgrupos, se compararon los resultados en pacientes con una y dos dosis de vacuna. Resultados : Se incluyeron 3663 pacientes (3001 [81.9%] no vacunados y 662 [18%] vacunados). El tiempo transcurrido desde el inicio de los síntomas hasta el pico de gravedad fue de 7 días (IQR 4 - 12) en no vacunados, y de 7 días (IQR 4-11) en vacunados. Tanto en el análisis de regresión de Cox crudo como en el ajustado, no se observaron diferencias significativas entre ambos grupos (HR ajustado 1.08 [IC 95% 0.82-1.4; p = 0.56]). En cuanto a la mortalidad, el Riesgo Relativo (RR) fue 1.51 (IC95% 1.29-1.77) en los pacientes vacunados, pero en la cohorte ajustada por Propensity Score, el RR fue de 0.73 (IC95% 0.60-0.88). El RR en el grupo con una dosis de vacuna COVID-19 en el análisis PSM fue 0.7 (IC95% 0.45-1.03), y con dos dosis 0.6 (IC95% 0.46-0.79). Discusión : El tiempo entre el inicio de los síntomas de COVID-19 y el pico de severidad fue igual en vacu nados y no vacunados. Sin embargo, los pacientes va cunados hospitalizados presentaron menor mortalidad tras el ajuste por confundidores.
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Abstract Objective To estimate the effect of tocilizumab or glucocorticoids in preventing death and intubation in patients hospitalized with SARS-CoV-2 pneumonia. Methods This was a retrospective cohort study enrolling all consecutive patients hospitalized at Reggio Emilia AUSL between February the 11th and April 14th 2020 for severe COVID-19 and treated with tocilizumab or glucocorticoids (at least 80 mg/day of methylprednisolone or equivalent for at least 3 days). The primary outcome was death within 30 days from the start of the considered therapies. The secondary outcome was a composite outcome of death and/or intubation. All patients have been followed-up until May 19th 2020, with a follow-up of at least 30 days for every patient. To reduce confounding due to potential non-comparability of the two groups, those receiving tocilizumab and those receiving glucocorticoids, a propensity score was calculated as the inverse probability weighting of receiving treatment conditional on the baseline covariates. Results and conclusion Therapy with tocilizumab alone was associated with a reduction of deaths (OR 0.49, 95% CI 0.21-1.17) and of the composite outcome death/intubation (OR 0.35, 95% CI 0.13-0.90) compared to glucocorticoids alone. Nevertheless, this result should be cautiously interpreted due to a potential prescription bias.
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ABSTRACT Introduction: In the current standard of care (SoC) RT-PCR method for COVID-19, the patient's swab was extracted in viral transport media (VTM). For the PanbioTM COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the PanbioTM COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result. Methods: The study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results. Results: For the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98]. Conclusion: The study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RTPCR without the need for new swab collections.