A randomized, double-blind, controlled trial of convalescent plasma in adults with severe COVID-19

BackgroundAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited. ObjectiveTo evaluate the clinical efficacy and safety of convalescent plasma among adults hospitalized with severe and critical COVID-19. DesignRandomized, double-blind, controlled, multicenter, phase 2 trial conducted from April 21st to November 27th, 2020. SettingFive hospitals in New York City (NY, USA) and Rio de Janeiro (Brazil). ParticipantsHospitalized patients aged [≥]18 years with laboratory-confirmed COVID-19, infiltrates on chest imaging and oxygen saturation [≤] 94% on room air or requirement for supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. InterventionParticipants were randomized 2:1 to a single transfusion of either 1 unit of convalescent or normal control plasma. MeasurementsThe primary outcome was clinical status at 28 days, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population. ResultsOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to normal control plasma. At 28 days, no significant improvement in clinical status was observed in participants randomized to convalescent plasma (with an odds ratio (OR) of a 1-point improvement in the scale: 1.50, 95% confidence interval (CI) 0.83-2.68, p=0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, p=0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples (n=40) from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected. Serious adverse events occurred in 39/147 (27%) participants who received convalescent plasma and 26/72 (36%) participants who received control plasma. LimitationsSome participants did not receive high-titer convalescent plasma. ConclusionIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in 28 days clinical status. The significant reduction in mortality associated with convalescent plasma, however, may warrant further evaluation. RegistrationClinicalTrials.gov, NCT04359810 FundingAmazon Foundation Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT04359810

PREP Profilaxia e pré exposição ao HIV

Já imaginou tomar um comprimido por dia e diminuir de maneira significativa as chances de contrair o HIV em caso de uma exposição? É basicamente assim que funciona o novo método de prevenção ao HIV oferecido pelo Ministério da Saúde. A Profilaxia Pré-Exposição, ou PrEP, como é mais conhecida, é um dos componentes da abordagem adotada pelo Ministério para combater o HIV, chamada de prevenção combinada, onde a pessoa tem a opção de usar um método de prevenção ou combinar vários que se ajustem às suas necessidades, características individuais ou momentos de vida. É dentro desse contexto que o SUS passa a oferecer a pílula que combina o medicamento tenofovir e o entricitabina. Um único medicamento por dia é tomado regularmente, mesmo que não haja suspeita de exposição, pois o objetivo é que ela funcione como uma barreira para o HIV antes da pessoa ter contato com o vírus. A apresentadora Mônica Bittencourt conversa com a Diretora do INI/Fiocruz, Valdiléa Veloso sobre a PrEP. Participante: Júlio Moreira, diretor sóciocultural do Grupo Arco-íris.