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Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma

Devos et al., European Respiratory Journal, doi:10.1183/13993003.01724-2021, DAWn-plasma, NCT04429854
Aug 2021  
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Mortality 1% Improvement Relative Risk Ventilation -8% ICU admission 0% Conv. Plasma  DAWn-plasma  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 483 patients in Belgium (May 2020 - January 2021) No significant difference in outcomes seen c19early.org Devos et al., European Respiratory J., Aug 2021 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 489 hospitalized COVID-19 patients in Belgium, showing no significant difference in outcomes with convalescent plasma.
risk of death, 1.0% lower, HR 0.99, p = 0.98, treatment 320, control 163.
risk of mechanical ventilation, 8.0% higher, HR 1.08, p = 0.78, treatment 320, control 163.
risk of ICU admission, no change, HR 1.00, p = 1.00, treatment 320, control 163.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Devos et al., 26 Aug 2021, Randomized Controlled Trial, Belgium, peer-reviewed, 26 authors, study period 2 May, 2020 - 26 January, 2021, average treatment delay 7.0 days, trial NCT04429854 (history) (DAWn-plasma). Contact: geert.meyfroidt@uzleuven.be.
This PaperConv. PlasmaAll
Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma
Timothy Devos, Quentin Van Thillo, Veerle Compernolle, Tomé Najdovski, Marta Romano, Nicolas Dauby, Laurent Jadot, Mathias Leys, Evelyne Maillart, Sarah Loof, Lucie Seyler, Martial Moonen, Michel Moutschen, Niels Van Regenmortel, Kevin K Ariën, Cyril Barbezange, Albrecht Betrains, Mutien Garigliany, Matthias M Engelen, Iwein Gyselinck, Piet Maes, Alexander Schauwvlieghe, Laurens Liesenborghs, Ann Belmans, Peter Verhamme, Geert Meyfroidt
European Respiratory Journal, doi:10.1183/13993003.01724-2021
Early transfusion of 4 units of high neutralising antibody titre convalescent plasma in hospitalised COVID-19 patients does not reduce mortality or the need for mechanical ventilation https://bit.ly/ 3fiRY2I
References
Abani, Abbas, Abbas, Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial, Lancet
Agarwal, Mukherjee, Kumar, Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial), BMJ
Beigel, Tomashek, Dodd, Remdesivir for the treatment of Covid-19 -final report, N Engl J Med
Betrains, Godinas, Woei-A-Jin, Convalescent plasma treatment of persistent severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in patients with lymphoma with impaired humoral immunity and lack of neutralising antibodies, Br J Haematol
Devos, Geukens, Schauwvlieghe, A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial, Trials
Gharbharan, Jordans, Geurtsvankessel, Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection, Nat Commun
Goldberg, Zvi, Sheena, A real-life setting evaluation of the effect of remdesivir on viral load in COVID-19 patients admitted to a large tertiary centre in Israel, Clin Microbiol Infect
Grasselli, Pesenti, Cecconi, Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response, JAMA
Guimarães, Quirk, Furtado, Tofacitinib in patients hospitalized with Covid-19 pneumonia, N Engl J Med
Hueso, Pouderoux, Péré, Convalescent plasma therapy for B-cell-depleted patients with protracted COVID-19, Blood
Janiaud, Axfors, Schmitt, Association of convalescent plasma treatment with clinical outcomes in patients with COVID-19: a systematic review and meta-analysis, JAMA
Joyner, Carter, Senefeld, Convalescent plasma antibody levels and the risk of death from Covid-19, N Engl J Med
Libster, Marc, Wappner, Early high-titer plasma therapy to prevent severe Covid-19 in older adults, N Engl J Med
O'donnell, Grinsztejn, Cummings, A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19, J Clin Invest
Rubin, Multiple imputation after 18+ years, J Am Stat Assoc
Salama, Han, Yau, Tocilizumab in patients hospitalized with Covid-19 pneumonia, N Engl J Med
Simonovich, Pratx, Scibona, A randomized trial of convalescent plasma in Covid-19 severe pneumonia, N Engl J Med
Taccone, Van Goethem, Pauw, The role of organizational characteristics on the outcome of COVID-19 patients admitted to the ICU in Belgium, Lancet Reg Health Eur
The, Group, Dexamethasone in hospitalized patients with Covid-19, N Engl J Med
The, Investigators, Interleukin-6 receptor antagonists in critically ill patients with Covid-19, N Engl J Med
Verity, Okell, Dorigatti, Estimates of the severity of coronavirus disease 2019: a model-based analysis, Lancet Infect Dis
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Plasma from donors with ' 'neutralising antibody titres (50% neutralisation titre (NT<jats:sub>50</jats:sub>)) ≥1/320 ' 'was the product of choice for the ' 'study.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Between 2 May ' '2020 and 26 January 2021, 320 patients were randomised to convalescent plasma and 163 ' 'patients to the control group according to a 2:1 allocation scheme. A median (interquartile ' 'range) volume of 884 (806–906)\u2005mL) convalescent plasma was administered and 80.68% of ' 'the units came from donors with neutralising antibody titres (NT<jats:sub>50</jats:sub>) ' '≥1/320. Median time from onset of symptoms to randomisation was 7\u2005days. The proportion ' 'of patients alive and free of mechanical ventilation on day 15 was not different between both ' 'groups (convalescent plasma 83.74% (n=267) <jats:italic>versus</jats:italic> control 84.05% ' '(n=137)) (OR 0.99, 95% CI 0.59–1.66; p=0.9772). The intervention did not change the natural ' 'course of antibody titres. The number of serious or severe adverse events was similar in both ' 'study arms and transfusion-related side-effects were reported in 19 out of 320 patients in ' 'the intervention group ' '(5.94%).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Transfusion ' 'of 4\u2005units of convalescent plasma with high neutralising antibody titres early in ' 'hospitalised COVID-19 patients did not result in a significant improvement of clinical status ' 'or reduced mortality.</jats:p></jats:sec>', 'DOI': '10.1183/13993003.01724-2021', 'type': 'journal-article', 'created': {'date-parts': [[2021, 8, 26]], 'date-time': '2021-08-26T16:16:09Z', 'timestamp': 1629994569000}, 'page': '2101724', 'update-policy': 'http://dx.doi.org/10.1183/ers-crossmark-policy', 'source': 'Crossref', 'is-referenced-by-count': 25, 'title': 'Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma', 'prefix': '10.1183', 'volume': '59', 'author': [ {'given': 'Timothy', 'family': 'Devos', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-3260-280X', 'authenticated-orcid': False, 'given': 'Quentin', 'family': 'Van Thillo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Veerle', 'family': 'Compernolle', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tomé', 'family': 'Najdovski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marta', 'family': 'Romano', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-7697-6849', 'authenticated-orcid': False, 'given': 'Nicolas', 'family': 'Dauby', 'sequence': 'additional', 'affiliation': []}, {'given': 'Laurent', 'family': 'Jadot', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mathias', 'family': 'Leys', 'sequence': 'additional', 'affiliation': []}, {'given': 'Evelyne', 'family': 'Maillart', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sarah', 'family': 'Loof', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lucie', 'family': 'Seyler', 'sequence': 'additional', 'affiliation': []}, {'given': 'Martial', 'family': 'Moonen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michel', 'family': 'Moutschen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Niels', 'family': 'Van Regenmortel', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kevin K.', 'family': 'Ariën', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cyril', 'family': 'Barbezange', 'sequence': 'additional', 'affiliation': []}, {'given': 'Albrecht', 'family': 'Betrains', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mutien', 'family': 'Garigliany', 'sequence': 'additional', 'affiliation': []}, {'given': 'Matthias M.', 'family': 'Engelen', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4068-7228', 'authenticated-orcid': False, 'given': 'Iwein', 'family': 'Gyselinck', 'sequence': 'additional', 'affiliation': []}, {'given': 'Piet', 'family': 'Maes', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alexander', 'family': 'Schauwvlieghe', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5616-8548', 'authenticated-orcid': False, 'given': 'Laurens', 'family': 'Liesenborghs', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ann', 'family': 'Belmans', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-8698-2858', 'authenticated-orcid': False, 'given': 'Peter', 'family': 'Verhamme', 'sequence': 'additional', 'affiliation': []}, {'given': 'Geert', 'family': 'Meyfroidt', 'sequence': 'additional', 'affiliation': []}], 'member': '81', 'published-online': {'date-parts': [[2021, 8, 26]]}, 'reference': [ { 'key': '2022021001300748000_59.2.2101724.1', 'unstructured': 'World Health Organization . WHO coronavirus (COVID-19) dashboard with ' 'vaccination data. 2021. https://covid19.who.int Date last accessed: 16 ' 'July 2021.'}, { 'key': '2022021001300748000_59.2.2101724.2', 'doi-asserted-by': 'crossref', 'first-page': '1545', 'DOI': '10.1001/jama.2020.4031', 'article-title': 'Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: ' 'early experience and forecast during an emergency response', 'volume': '323', 'author': 'Grasselli', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '2022021001300748000_59.2.2101724.3', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S1473-3099(20)30243-7'}, { 'key': '2022021001300748000_59.2.2101724.4', 'doi-asserted-by': 'crossref', 'first-page': '100019', 'DOI': '10.1016/j.lanepe.2020.100019', 'article-title': 'The role of organizational characteristics on the outcome of COVID-19 ' 'patients admitted to the ICU in Belgium', 'volume': '2', 'author': 'Taccone', 'year': '2021', 'journal-title': 'Lancet Reg Health Eur'}, { 'key': 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Late treatment
is less effective
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