Administering high-titer convalescent plasma (CP) to hospitalized patients with moderate-to-severe coronavirus disease 2019 (COVID-19) pneumonia does not appear to slow progression to severe respiratory failure or death within 30 days, according to clinical trial results published in JAMA Network Open.
Although CP from individuals recovered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been suggested as therapy for patients with COVID-19, clinical evidence has demonstrated that it has been largely unsuccessful in preventing worsening of respiratory failure or death. However, a relationship between neutralizing antibody titer and a more favorable clinical outcome has been suggested.
Researchers for the prospective, open-label TSUNAMI trial (ClinicalTrials.gov Identifier: NCT04716556) evaluated the efficacy of CP plus standard therapy (ST) in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia at 27 clinical sites in Italy. Eligible patients included hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen–to–fraction of inspired oxygen (PaO2/FiO2) ratio between 350 and 200 mm Hg.
Among study participants, 241 patients received 200 mL of intravenous high-titer CP (≥1:160, by microneutralization test) given in 1 to 3 infusions plus ST and 246 patients received ST alone (remdesivir, glucocorticoids, and low–molecular weight heparin). The primary outcome was a composite of worsening respiratory failure (PaO2/FiO2 ratio <150 mm Hg) or death within 30 days. The researchers found that the primary endpoint occurred in 59 of the 231 patients (25.5%) treated with CP plus ST, and in 67 of the 239 patients (28.0%) who received ST alone (P=.54), but adverse events occurred more frequently in the CP group (12/241 [5.0%]) compared with the control group (4/246 [1.6%]; P=.04).
The authors concluded, “In patients with moderate to severe COVID-19 pneumonia, high-titer anti–SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Menichetti F, Popoli P, Puopolo M, et al; the TSUNAMI Study Group. 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. JAMA Network Open. 2021;4(11):e2136246. doi:10.1001/jamanetworkopen.2021.36246