Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI).

Background: Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19. Methods: We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086. Findings: Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (n = 42), Low-volume (n = 43) or High-volume (n = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion. Interpretation: In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits. Funding: Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.

Comparison of different polishing methods on the surface roughness of microhybrid, microfill, and nanofill composite resins.

AIM: The aim of the present study was to evaluate the effect of different polishing methods on the surface roughness of resin-based composites subjected to a thermocycling procedure. METHODS: A total of 192 specimens were divided into 24 groups, according to composite materials (Filtek Z250, Point 4, Renamel Nanofill, Filtek Supreme Plus, Renamel Microfill, and Premise) and finishing and polishing systems (Sof-Lex Pop On, Super Snap, Flexidisc, and Flexidisc+Enamelize). The specimens were subjected to thermocycling (5000 cycles). RESULTS: Filtek Supreme Plus showed the lowest surface roughness values before thermocycling. After thermocycling, Filtek Supreme Plus continued to have the lowest surface roughness, with a statistically-significant difference for the other materials. After thermocycling, there was no statistically-significant difference among all the polishing techniques studied. CONCLUSIONS: The thermocycling was concluded as being able to change composite resins' surface roughness, whereas different finishing and polishing methods did not result in surface roughness changes after thermocycling.