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Double-blinded, randomised, placebo-controlled trial of convalescent plasma for COVID-19: analyses by neutralising antibodies homologous to donors’ variants

Khawaja et al., Infectious Diseases, doi:10.1080/23744235.2024.2329957, CP_COVID-19, NCT04730401
Mar 2024  
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Mortality -154% Improvement Relative Risk Ventilation 73% ICU admission 46% Conv. Plasma  CP_COVID-19  LATE TREATMENT  DB RCT Is late treatment with convalescent plasma beneficial for COVID-19? Double-blind RCT 57 patients in Finland (February 2021 - January 2022) Trial underpowered to detect differences c19early.org Khawaja et al., Infectious Diseases, Mar 2024 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 57 hospitalized COVID-19 patients showing no significant difference in outcomes with convalescent plasma treatment.
risk of death, 154.1% higher, RR 2.54, p = 1.00, treatment 1 of 37 (2.7%), control 0 of 20 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 73.0% lower, RR 0.27, p = 0.28, treatment 1 of 37 (2.7%), control 2 of 20 (10.0%), NNT 14.
risk of ICU admission, 45.9% lower, RR 0.54, p = 0.65, treatment 3 of 37 (8.1%), control 3 of 20 (15.0%), NNT 15.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Khawaja et al., 21 Mar 2024, Double Blind Randomized Controlled Trial, placebo-controlled, Finland, peer-reviewed, mean age 51.7, 23 authors, study period 2 February, 2021 - 19 January, 2022, average treatment delay 8.0 days, trial NCT04730401 (history) (CP_COVID-19). Contact: anu.kantele@helsinki.fi.
This PaperConv. PlasmaAll
Double-blinded, randomised, placebo-controlled trial of convalescent plasma for COVID-19: analyses by neutralising antibodies homologous to donors’ variants
T Khawaja, M Kajova, I Levonen, J P Pietilä, H Välimaa, J Paajanen, S H Pakkanen, A Patjas, R Montonen, S Miettinen, J Virtanen, T Smura, T Sironen, R Fagerlund, H Ugurlu, R Iheozor-Ejiofor, K Saksela, T Vahlberg, A Ranki, A Vierikko, J Ihalainen, O Vapalahti, A Kantele
Infectious Diseases, doi:10.1080/23744235.2024.2329957
Introduction: Convalescent plasma (CP) emerged as potential treatment for COVID-19 early in the pandemic. While efficacy in hospitalised patients has been lacklustre, CP may be beneficial at the first stages of disease. Despite multiple new variants emerging, no trials have involved analyses on variant-specific antibody titres of CP. Methods: We recruited hospitalised COVID-19 patients within 10 days of symptom onset and, employing a doubleblinded approach, randomised them to receive 200 ml convalescent plasma with high (HCP) or low (LCP) neutralising antibody (NAb) titre against the ancestral strain (Wuhan-like variant) or placebo in 1:1:1 ratio. Primary endpoints comprised intubation, corticosteroids for symptom aggravation, and safety assessed as serious adverse events. For a preplanned ad hoc analysis, the patients were regrouped by infused CP's NAb titers to variants infecting the recipients i.e. by titres of homologous HCP (hHCP) or LCP (hLCP). Results: Of the 57 patients, 18 received HCP, 19 LCP and 20 placebo, all groups smaller than planned. No significant differences were found for primary endpoints. In ad hoc analysis, hHCPrecipients needed significantly less respiratory support, and appeared to be given corticosteroids less frequently (1/14; 7.1%) than those receiving hLCP (9/23; 39.1%) or placebo (8/20; 40%), (p ¼ 0.077). Discussion: Our double-blinded, placebo-controlled CP therapy trial remained underpowered and does not allow any firm conclusions for early-stage hospitalised COVID-19 patients. Interestingly, however, regrouping by homologous -recipients' variantspecific -CP titres suggested benefits for hHCP. We encourage similar re-analysis of ongoing/previous larger CP studies.
Disclosure statement The authors report there are no competing interests to declare.
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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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