High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial.

BACKGROUND: Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence. We aimed to assess whether early treatment with convalescent plasma reduces the risk of hospitalisation and reduces SARS-CoV-2 viral load among outpatients with COVID-19. METHODS: We did a multicentre, double-blind, randomised, placebo-controlled trial in four health-care centres in Catalonia, Spain. Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment. Participants were randomly assigned (1:1) to receive one intravenous infusion of either 250-300 mL of ABO-compatible high anti-SARS-CoV-2 IgG titres (EUROIMMUN ratio ≥6) methylene blue-treated convalescent plasma (experimental group) or 250 mL of sterile 0·9% saline solution (control). Randomisation was done with the use of a central web-based system with concealment of the trial group assignment and no stratification. To preserve masking, we used opaque tubular bags that covered the investigational product and the infusion catheter. The coprimary endpoints were the incidence of hospitalisation within 28 days from baseline and the mean change in viral load (in log10 copies per mL) in nasopharyngeal swabs from baseline to day 7. The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccine. Primary efficacy analyses were done in the intention-to-treat population, safety was assessed in all patients who received the investigational product. This study is registered with ClinicalTrials.gov, NCT04621123. FINDINGS: Between Nov 10, 2020, and July 28, 2021, we assessed 909 patients with confirmed COVID-19 for inclusion in the trial, 376 of whom were eligible and were randomly assigned to treatment (convalescent plasma n=188 [serum antibody-negative n=160]; placebo n=188 [serum antibody-negative n=166]). Median age was 56 years (IQR 52-62) and the mean symptom duration was 4·4 days (SD 1·4) before random assignment. In the intention-to-treat population, hospitalisation within 28 days from baseline occurred in 22 (12%) participants who received convalescent plasma versus 21 (11%) who received placebo (relative risk 1·05 [95% CI 0·78 to 1·41]). The mean change in viral load from baseline to day 7 was -2·41 log10 copies per mL (SD 1·32) with convalescent plasma and -2·32 log10 copies per mL (1·43) with placebo (crude difference -0·10 log10 copies per mL [95% CI -0·35 to 0·15]). One participant with mild COVID-19 developed a thromboembolic event 7 days after convalescent plasma infusion, which was reported as a serious adverse event possibly related to COVID-19 or to the experimental intervention. INTERPRETATION: Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19. Therefore, formal recommendations to support the use of convalescent plasma in outpatients with COVID-19 cannot be concluded. FUNDING: Grifols, Crowdfunding campaign YoMeCorono.

Reestructuración del funcionamiento de la Unidad de Hospitalización a Domicilio del Hospital Universitario Germans Trias I Pujol para el manejo de pacientes COVID y no COVID ingresados durante la pandemia del COVID-19 en España / Restructuring the Operation of the Home Care Unit of the Germans Trias I Pujol University Hospital for the management of patients COVID and no COVID Admitted during the COVID-19 Pandemic in Spain

INTRODUCCIÓN: La Unidad de Hospitalización a Domicilio del Hospital Universitari Germans Trias I Pujol, ante la grave situación sanitaria generada por el COVID-19 optó por varias estrategias para la atención de los pacientes ingresados con o sin diagnóstico de COVID optimizando los recursos de atención sanitaria. MÉTODO: Estudio descriptivo sobre la reorganización de la Unidad de Hospitalización a Domicilio (UHAD) durante la pandemia del COVID-19 en el período comprendido entre el 14 de Marzo y 31 de Mayo del 2020. Una ampliación del número de camas virtuales, así como de los turnos e incorporación de personal sanitario (médico/enfermeros) fue necesario, activándose paralelamente 2 plataformas de telemedicina para monitorización y contacto con los pacientes (COVIDApp para los pacientes COVID y Revita para los pacientes no COVID). RESULTADOS: Un total de 781 pacientes referidos del área de hospitalización, urgencias y atención primaria fueron incluidos, 584 (74,8%) ingresados con diagnóstico de COVID-19 (por PCR = polymerase chain reaction) y 197 (25,2%) pacientes ingresados por otras patologías (no-COVID) provenientes de la zona Metropolitana Nord de Barcelona y Maresme. Un 24,6% de los pacientes no-COVID y un 2,5% de los pacientes COVID eran pacientes crónicos complejos. El porcentaje de reingreso hospitalario fue mayor en los pacientes no-COVID (11.6%) que en los pacientes COVID (4,28%). El porcentaje de altas de la UHAD aumentó hasta un 35,34%. Ambas plataformas permitieron realizar seguimiento estrecho de los pacientes. CONCLUSIONES: La pandemia del COVID-19 ha remarcado la necesidad de optimizar y reestructurar los recursos del sistema sanitario, siendo las plataformas de Telemedicina COVIDApp y Revita de ayuda como herramientas innovadoras

INTRODUCTION: The COVID-19 pandemic made that the Home Care Unit of the Germans Trias I Pujol University Hospital implement strategies for the management of patients admitted with or without COVID-19, optimizing health care resources. METHOD: A descriptive study of patients with and without COVID-19 was conducted between March 14th and May 31th, 2020. An increase in the number of virtual beds, as well as extension of working hour and incorporation of personnel health (doctor/nurses) was necessary, activating 2 telemedicine platforms for monitoring of patients (COVIDApp for COVID patients and Revita for non-COVID patients). RESULTS: A total of 781 patients referred from the hospitalization, emergency and primary care were included, 584 (74.8%) admitted with a diagnosis of COVID-19 (by PCR) and 197 (25.2%) patients admitted by other pathologies (non-COVID) from the Nord Metropolitan area of Barcelona and Maresme. 24.6% of non-COVID patients and 2.5% of COVID patients were complex chronic patients. The percentage of hospital readmission was higher in non-COVID patients (11.6%) than in COVID patients (4.28%). The percentage of discharges from the UHAD increased to 35.34%. Both platforms allowed for close monitoring of patients. CONCLUSIONS: The COVID-19 pandemic has highlighted the need to optimize and restructure the resources of the health system, with the Telemedicine platforms COVIDApp and Revita as innovative tools

Tratamiento antibiótico por vía intravenosa domiciliario y hospitalización a domicilio / Home intravenous antibiotic treatment and home hospitalization

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