Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)
Scientific reports. 2022;12(1):2552
There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.
Water administration and the risk of syncope and presyncope during blood donation: a randomized clinical trial
BACKGROUND Blood centers rely heavily on adolescent donors to meet blood demand, but presyncope and syncope are more frequent in younger donors. Studies have suggested administration of water before donation may reduce syncope and/or presyncope in this group. STUDY DESIGN AND METHODS We conducted a randomized, controlled trial to establish the effect of preloading with 500mL of water on the rate of syncope and presyncope in adolescent donors. School collection sites in Eastern Cape Province of South Africa were randomized to receive water or not. Incidence of syncope and presyncope was compared between randomization groups using multivariable logistic regression. RESULTS Of 2464 study participants, 1337 received water and 1127 did not; groups differed slightly by sex and race. Syncope or presyncope was seen in 23 (1.7%) of the treatment and 18 (1.6%) of the control arm subjects. After adjusting for race, sex, age, and donation history, there was no difference in outcome between the water versus no water arms (adjusted odds ratio [OR],0.80; 95% confidence interval [CI], 0.42-1.53). Black donors had sevenfold lower odds of syncope or presyncope than their white counterparts (adjusted OR, 0.14; 95% CI, 0.04-0.47). CONCLUSION Preloading adolescent donors with 500mL of water did not have a major effect in reducing syncope and presyncope in South African adolescent donors. Our adolescent donors had lower overall syncope and presyncope rates than similar populations in the United States, limiting the statistical power of the study. We confirmed much lower rates of syncope and presyncope among young black donors. 2012 American Association of Blood Banks.