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All Studies   All Outcomes    Recent:   
0 0.5 1 1.5 2+ Mortality 17% Improvement Relative Risk Ventilation 67% Improvement 5% Discharge -3% Conv. Plasma  PROTECT-Patient  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 103 patients in South Africa (September 2020 - January 2021) Lower ventilation with convalescent plasma (not stat. sig., p=0.36) c19early.org van den Berg et al., Scientific Reports, Feb 2022 Favors conv. plasma Favors control

Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)

van den Berg et al., Scientific Reports, doi:10.1038/s41598-022-06221-8, PROTECT-Patient, NCT04516811
Feb 2022  
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RCT 103 hospitalized patients in South Africa, showing no significant difference in outcomes with convalescent plasma.
risk of death, 17.0% lower, RR 0.83, p = 0.65, treatment 11 of 52 (21.2%), control 13 of 51 (25.5%), NNT 23, day 28.
risk of mechanical ventilation, 67.3% lower, RR 0.33, p = 0.36, treatment 1 of 52 (1.9%), control 3 of 51 (5.9%), NNT 25.
risk of no improvement, 5.4% lower, RR 0.95, p = 1.00, treatment 16 of 47 (34.0%), control 18 of 50 (36.0%), NNT 51, day 28.
risk of no hospital discharge, 3.0% higher, RR 1.03, p = 1.00, treatment 18 of 46 (39.1%), control 19 of 50 (38.0%), day 28.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
van den Berg et al., 15 Feb 2022, Randomized Controlled Trial, placebo-controlled, South Africa, peer-reviewed, 30 authors, study period 30 September, 2020 - 14 January, 2021, average treatment delay 9.0 days, trial NCT04516811 (history) (PROTECT-Patient). Contact: karin.vandenberg@sanbs.org.za.
This PaperConv. PlasmaAll
Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)
Karin Van Den Berg, Tanya Nadia Glatt, Marion Vermeulen, Francesca Little, Ronel Swanevelder, Claire Barrett, Richard Court, Marise Bremer, Cynthia Nyoni, Avril Swarts, Cordelia Mmenu, Thomas Crede, Gerdien Kritzinger, Jonathan Naude, Patryk Szymanski, James Cowley, Thandeka Moyo-Gwete, Penny L Moore, John Black, Jaimendra Singh, Jinal N Bhiman, Prinita Baijnath, Priyesh Mody, Jacques Malherbe, Samantha Potgieter, Cloete Van Vuuren, Shaun Maasdorp, Robert J Wilkinson, Vernon J Louw, Sean Wasserman
Scientific Reports, doi:10.1038/s41598-022-06221-8
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
www.nature.com/scientificreports/ definitive conclusions, absence of a major safety signal is somewhat reassuring. In line with experience in other settings 11 , CCP use was safe in our overall cohort, supporting future evaluation for different indications in high HIV burden populations. The premature termination of the PROTECT trial illustrates the complexity of undertaking clinical research in a rapidly evolving global pandemic. Inconsistent case numbers, viral evolution, and rapidly changing evidence during the trial period contributed to this challenge. Despite this, our trial demonstrated the feasibility of deploying CCP in a resource-limited setting and contributed knowledge on the use of this therapeutic strategy for COVID-19 pneumonia. Our experience highlights the necessity of globally networked clinical trial sites and harmonised study protocols to more efficiently evaluate interventions among diverse populations during a pandemic. Competing interests The authors declare no competing interests.
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The primary outcome measure was hospital discharge and/or improvement ' 'of\u2009≥\u20092 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\xa0participants 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\xa0AU/mL). 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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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