Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia
RCT 487 patients in Italy, showing no significant difference in outcomes with convalescent plasma.
risk of death, 23.4% lower, RR 0.77, p = 0.47, treatment 14 of 231 (6.1%), control 19 of 240 (7.9%), NNT 54.
|
risk of mechanical ventilation, 3.9% higher, RR 1.04, p = 1.00, treatment 25 of 231 (10.8%), control 25 of 240 (10.4%), mechanical ventilation or death.
|
risk of progression, 12.0% lower, RR 0.88, p = 0.54, treatment 59 of 231 (25.5%), control 67 of 239 (28.0%), NNT 40, PaO2/FiO2 <150 mm Hg or death, primary outcome.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Menichetti et al., 29 Nov 2021, Randomized Controlled Trial, Italy, peer-reviewed, 110 authors, study period 15 July, 2020 - 8 December, 2020, average treatment delay 7.0 days, trial
NCT04716556 (history) (TSUNAMI).
Abstract: Original Investigation | Infectious Diseases
Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory
Failure or Death in Hospitalized Patients With COVID-19 Pneumonia
A Randomized Clinical Trial
Francesco Menichetti, MD; Patrizia Popoli, MD; Maria Puopolo, MS; Stefania Spila Alegiani, MS; Giusy Tiseo, MD; Alessandro Bartoloni, MD;
Giuseppe Vittorio De Socio, MD; Sauro Luchi, MD; Pierluigi Blanc, MD; Massimo Puoti, MD; Elena Toschi, MS; Marco Massari, MS; Lucia Palmisano, MS;
Giuseppe Marano, MD; Margherita Chiamenti, MD; Laura Martinelli, MD; Silvia Franchi, MD; Carlo Pallotto, MD; Lorenzo Roberto Suardi, MD;
Barbara Luciani Pasqua, MD; Marco Merli, MD; Plinio Fabiani, MD; Luca Bertolucci, MD; Beatrice Borchi, MD; Sara Modica, MD; Sara Moneta, MD; Giulia Marchetti, MD;
Antonella d’Arminio Monforte, MD; Laura Stoppini, MD; Nadia Ferracchiato, MD; Stefania Piconi, MD; Claudio Fabbri, MD; Enrico Beccastrini, MD; Riccardo Saccardi, MD;
Andrea Giacometti, MD; Sara Esperti, MD; Piera Pierotti, MD; Laura Bernini, MD; Claudia Bianco, MD; Sara Benedetti, MD; Alessandra Lanzi, MD; Paolo Bonfanti, MD;
Marco Massari, MD; Spartaco Sani, MD; Annalisa Saracino, MD; Antonella Castagna, MD; Luigia Trabace, PhD; Maria Lanza, MD; Daniele Focosi, MD;
Alessandro Mazzoni, MD; Mauro Pistello, MD; Marco Falcone, MD; for the TSUNAMI Study group
Abstract
Key Points
IMPORTANCE Convalescent plasma (CP) has been generally unsuccessful in preventing worsening
of respiratory failure or death in hospitalized patients with COVID-19 pneumonia.
Question Is convalescent plasma useful
in preventing worsening respiratory
failure or death in patients with
OBJECTIVE To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing
COVID-19 pneumonia?
Findings In this randomized clinical trial
worsening respiratory failure or death in patients with COVID-19 pneumonia.
of 487 patients with COVID-19
DESIGN, SETTING, AND PARTICIPANTS This prospective, open-label, randomized clinical trial
pneumonia and a partial pressure of
enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone
arterial oxygen–to–fraction of inspired
between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19
oxygen (PaO2/FiO2) ratio between 350
pneumonia and a partial pressure of oxygen–to–fraction of inspired oxygen (PaO2/FiO2) ratio between
and 200 mm Hg at enrollment, the rate
350 and 200 mm Hg were eligible.
of the primary clinical end point (need
for mechanical ventilation, defined as
INTERVENTIONS Patients in the experimental group received intravenous high-titer CP (ⱖ1:160, by
PaO2/FiO2 ratio <150 mm Hg, or death)
microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum
was not significantly different between
of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids,
the convalescent plasma group and the
and low–molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations.
control group.
Meaning In this trial, convalescent
MAIN OUTCOMES AND MEASURES The primary outcome was a composite of worsening
plasma did not reduce the progression
respiratory failure (PaO2/FiO2 ratio <150 mm Hg) or death within 30 days from randomization.
to severe respiratory failure or death
within 30 days.
RESULTS Of the 487 randomized patients (241 to CP plus ST;..
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, 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.
Submit