Evidence map›Paper›PMID 35169169›Full record

Trial reportScientific reports2022

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 and 20 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 8 pooled it
3.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 8 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Pooled it
  5. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Coagulation Profile of Convalescent Plasma Donors and Recipients.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Trial
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 9 institutions in 2 countries.

Karin van den BergMedical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa. Karin.vandenberg@sanbs.org.za.
Tanya Nadia GlattMedical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa.
Marion VermeulenDivision of Clinical Haematology, Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa.
Francesca LittleDepartment of Statistical Sciences, University of Cape Town, Observatory, South Africa.
Ronel SwanevelderMedical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa.
Claire BarrettSchool of Clinical Medicine, University of the Free State, Bloemfontein, South Africa.
Richard CourtDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Observatory, South Africa.
Marise BremerWellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
Cynthia NyoniMedical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa.
Avril SwartsMedical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa.
Cordelia MmenuOperations Division, Operations Testing Department, South African National Blood Service, Roodepoort, South Africa.
Thomas CredeMitchells Plain Hospital and the University of Cape Town's Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa.
Gerdien KritzingerDivision of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa.
Jonathan NaudeMitchells Plain Hospital and the University of Cape Town's Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa.
Patryk SzymanskiMitchells Plain Hospital and the University of Cape Town's Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa.
James CowleyOperations Division, Processing Department, South African National Blood Service, Roodepoort, South Africa.
Thandeka Moyo-GweteNational Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Penny L MooreNational Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
John BlackDepartment of Medicine, Walter Sisulu University, Livingstone Hospital, Gqeberha, South Africa.
Jaimendra SinghCapital Haematology Hospital and Bone Marrow Transplant Unit, Durban, South Africa.
Jinal N BhimanCentre for Respiratory Diseases and Meningitis (CRDM), National Institute for Communicable Diseases, Johannesburg, South Africa.
Prinita BaijnathLife Westville Hospital, Westville, South Africa.
Priyesh ModyLife Westville Hospital, Westville, South Africa.
Jacques MalherbeSchool of Clinical Medicine, University of the Free State, Bloemfontein, South Africa.
Samantha PotgieterDivision of Infectious Diseases, Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa.
Cloete van Vuuren3 Military Hospital and Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa.
Shaun MaasdorpPulmonology and Critical Care, Universitas Academic Hospital and Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa.
Robert J WilkinsonWellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
Vernon J Louw *Division of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa.
Sean Wasserman *Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
South African National Blood Service · ZAUniversity of Cape Town · ZAUniversity of the Free State · ZANational Health Laboratory Service · ZAUniversity of KwaZulu-Natal · ZAWellcome Centre for Infectious Diseases Research in Africa · ZAImperial College London · GBLivingstone Hospital · ZARespiratory and Meningeal Pathogens Research Unit · ZA

Funding

Research training in HIV-related transfusion medicine and hematology in South AfricaD43TW010345 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI UTE JENTSCH, EDWARD L MURPHY · 2017 to 2026
$3.0M
Characterizing the pharmacokinetics of high dose rifampicin and linezolid in a randomized controlled trial for HIV-associated tuberculous meningitisK43TW011421 · FIC · UNIVERSITY OF CAPE TOWN · PI WASSERMAN, SEAN ADAM · 2019 to 2022
$404k
Cancer Research UK FC0010218FIC NIH HHS D43 TW010345FIC NIH HHS K43 TW011421Medical Research Council FC0010218National Institute of Health, South Africa K43TW011421NIH Fogarty International Center Training Grant 1D43-TW010345South African Research Chairs Initiative of the Department of Science and Innovation and the National Research Foundation 98341Wellcome Trust 202254Wellcome Trust 203135Wellcome Trust 203135/Z/16/ZWellcome Trust FC0010218
6 · The paper itself

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.

Indexed as

AdultCOVID-19COVID-19 SerotherapyDouble-Blind MethodFemaleHIV InfectionsHospitals, PublicHumansImmunization, PassiveKaplan-Meier EstimateMaleMiddle AgedPlacebo EffectSARS-CoV-2Severity of Illness IndexSouth Africa

Identifiers

PMID35169169
PMCPMC8847351
OpenAlexW4213151746

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.