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SARS-CoV-2 neutralizing antibody treatment in COVID-19 patients with immunodeficiency due to B-cell non-Hodgkin lymphoma.

ABSTRACT: Humoral immunodeficiency is a common finding in patients with B-cell related malignancies such as Non-Hodgkin lymphoma. Failure to induce a sufficient humoral immune response to viral pathogens such as SARS-CoV-2 can result in impaired viral clearance with prolonged viral shedding and symptomatic infections. Here we describe six COVID-19 patients with B-cell Non-Hodgkin lymphoma and impaired humoral immune response that were successfully treated with SARS-CoV-2 neutralizing monoclonal antibodies (nMABs) between June and October 2021. Patients exhibited serological vaccination failure or were unable to clear SARS-CoV-2 even after prolonged infections. Two patients presented with persistent COVID-19 for more than three months. One patient suffered from a third episode of COVID-19 despite vaccination and one patient was diagnosed by SARS-CoV-2 viremia and a positive PCR from the lower respiratory tract while subsequent nasopharyngeal swabs remained negative. In the six described cases, passive immunization with nMABs resulted in rapid and sustained clinical improvement and decrease in viral loads. SARS-CoV-2 nMABs provide a highly attractive treatment option for COVID-19 patients unable to mount a humoral immune response following vaccination or infection.

SUBMITTER: Malin JJ

PROVIDER: S-EPMC8683250 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization.MethodsIn this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here.ResultsAt the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P?=?0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P?=?0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P?=?0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.ConclusionsIn this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

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SARS-CoV-2 neutralizing antibody treatment in COVID-19 patients with immunodeficiency due to B-cell non-Hodgkin lymphoma.

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