Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.

BACKGROUND: The efficacy of early treatment with convalescent plasma in patients with COVID-19 is debated. Nothing is known about the potential effect of other plasma components other than anti-SARS-CoV-2 antibodies. METHODS: To determine whether convalescent or standard plasma would improve outcomes for adults in early phase of Covid19 respiratory impairment we designed this randomized, three-arms, clinical trial (PLACO COVID) blinded on interventional arms that was conducted from June 2020 to August 2021. It was a multicentric trial at 19 Italian hospitals. We enrolled 180 hospitalized adult patients with COVID-19 pneumonia within 5 days from the onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard of care (n = 60) or standard of care + three units of standard plasma (n = 60) or standard of care + three units of high-titre convalescent plasma (n = 60) administered on days 1, 3, 5 after randomization. Primary outcome was 30-days mortality. Secondary outcomes were: incidence of mechanical ventilation or death at day 30, 6-month mortality, proportion of days with mechanical ventilation on total length of hospital stay, IgG anti-SARS-CoV-2 seroconversion, viral clearance from plasma and respiratory tract samples, and variations in Sequential Organ Failure Assessment score. The trial was analysed according to the intention-to-treat principle. RESULTS: 180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57-73]) were enrolled a median of 8 days from onset of symptoms. At enrollment, 88.9% of patients showed moderate/severe respiratory failure. 30-days mortality was 20% in Control arm, 23% in Convalescent (risk ratio [RR] 1.13; 95% confidence interval [CI], 0.61-2.13, P = 0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63-2.37, P = 0.544). Time to viral clearance from respiratory tract was 21 days for Convalescent, 28 for Standard plasma and 23 in Control arm but differences were not statistically significant. No differences for other secondary endpoints were seen in the three arms. Serious adverse events were reported in 1.7%, 3.3% and 5% of patients in Control, Standard and Convalescent plasma arms respectively. CONCLUSIONS: Neither high-titer Convalescent nor Standard plasma improve outcomes of COVID-19 patients with acute respiratory failure. Trial Registration Clinicaltrials.gov Identifier: NCT04428021. First posted: 11/06/2020.

Blood bank preparedness for mass casualty incidents and disasters: a pilot study in the Piedmont region, Italy.

BACKGROUND AND OBJECTIVES: Blood is a critical resource for responding to mass casualty incidents (MCI). The main framework for transfusion preparedness is the American Association of Blood Bank (AABB) Disaster Operation Handbook. A disaster preparedness plan for co-ordinated blood supply was issued in Italy in 2016. AIM: To assess the level of preparedness of the Transfusion Centers (TS) in the Piedmont region, to evaluate the applicability of AABB checklist and to evaluate the application of the Italian plan. MATERIALS AND METHODS: We surveyed all the Regional Transfusion Centers (TS) using the AABB checklist, addressing 74 priority action items grouped according to 16 preparedness domains. The Italian 2016 plan has been considered the regulatory cut-off and hospitals were stratified based on the type and the TS workload. A principal component analysis (PCA) was conducted to summarize the variance among centres. RESULTS: Twenty-one out of 25 TS agreed to participate. Eighty-one % were at high and 18% were at medium level of preparedness. All but two centres were above the cut-off determined by the Italian law. A significant better preparedness was found in medium size hospitals compared to bigger and smaller hospitals. Other than that, the different TS showed a quite homogeneous distribution of preparedness variance. CONCLUSIONS: This study demonstrated a good level of preparedness in the Piemonte TS, above the Italian law requirements in the majority of TS. The AABB checklist could be used to highlight gaps and needs in the regional TS networks in case of emergency crisis.