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

Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial). van den Berg, K., Glatt, T. N., Vermeulen, M., Little, F., Swanevelder, R., Barrett, C., Court, R., Bremer, M., Nyoni, C., Swarts, A., Mmenu, C., Crede, T., Kritzinger, G., Naude, J., Szymanski, P., Cowley, J., Moyo-Gwete, T., Moore, P. L, Black, J., Singh, J., Bhiman, J. N, Baijnath, P., Mody, P., Malherbe, J., Potgieter, S., van Vuuren, C., Maasdorp, S., Wilkinson, R. J, Louw, V. J, & Wasserman, S. Scientific Reports, 12(1):2552, Nature Publishing Group, dec, 2022.

Paper doi abstract bibtex

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.

@article{VandenBerg2022,
abstract = {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.},
author = {van den Berg, Karin and Glatt, Tanya Nadia and Vermeulen, Marion and Little, Francesca and Swanevelder, Ronel and Barrett, Claire and Court, Richard and Bremer, Marise and Nyoni, Cynthia and Swarts, Avril and Mmenu, Cordelia and Crede, Thomas and Kritzinger, Gerdien and Naude, Jonathan and Szymanski, Patryk and Cowley, James and Moyo-Gwete, Thandeka and Moore, Penny L and Black, John and Singh, Jaimendra and Bhiman, Jinal N and Baijnath, Prinita and Mody, Priyesh and Malherbe, Jacques and Potgieter, Samantha and van Vuuren, Cloete and Maasdorp, Shaun and Wilkinson, Robert J and Louw, Vernon J and Wasserman, Sean},
doi = {10.1038/s41598-022-06221-8},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/van den Berg et al. - 2022 - Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia a randomized controlled trial.pdf:pdf},
isbn = {0123456789},
issn = {2045-2322},
journal = {Scientific Reports},
keywords = {Clinical trial design,Clinical trials,OA,OA{\_}PMC,Randomized controlled trials,fund{\_}ack,genomics{\_}fund{\_}ack,original},
mendeley-tags = {OA,OA{\_}PMC,fund{\_}ack,genomics{\_}fund{\_}ack,original},
month = {dec},
number = {1},
pages = {2552},
pmid = {35169169},
publisher = {Nature Publishing Group},
title = {{Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)}},
url = {https://www.nature.com/articles/s41598-022-06221-8},
volume = {12},
year = {2022}
}

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