In a recent Phase 3 study published in The Lancet Respiratory Medicine, scientists evaluated the potential of tixagevimab-cilgavimab for the treatment of hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Despite advances in treatment, the addition of dexamethasone, additional immune modulators, remdesivir, and anticoagulants, mortality remains prevalent in hospitalized patients with CoV disease 2019 (COVID-19). CoV-2, neutralizing monoclonal antibodies selectively bind to sars-CoV-2 spike protein (S), minimize viral replication in animal and in vitro models, and restrict clinical effects on evolution and hospitalization.
In the RECOVERY study, handling the casirivimab-imdevimab monoclonal antibody cocktail to hospitalized patients who tested negative for SERONS-CoV-2 reduced mortality rates. On the other hand, variants of SARS-CoV-2 Omicron exhibit total resistance to this mixture of monoclonal antibodies. and reduced sensitivity to others.
Tixagevimab-cilgavimab, an aggregate of two monoclonal antibodies with a half-life of approximately 90 days, excluded symptomatic COVID-19 when used as pre-exposure prophylaxis. In addition, when administered at the onset of SARS-CoV-2 infection, it reduced hospitalizations by more than 50% in non-hospitalized subjects and maintained its antiviral efficacy against Omicron variants.
In the current phase 3, double-blind, randomized, placebo-controlled study, researchers thixagevimab-cilgavimab with placebo in hospitalized patients with SARS-CoV-2 treated with remdesivir and other regimen treatments.
Adults with SARS-CoV-2 symptoms that lasted approximately 12 days and hospitalized for COVID-19 at 81 sites in the United States of America (United States), Singapore, Europe, and Uganda were randomly assigned in a 1:1 ratio to obtain tixagevimab (300 mg)-cilgavimab (300 mg) intravenously or placebo with remdesivir and traditional care.
If patients required extracorporeal membrane oxygenation, invasive mechanical ventilation, mechanical circulatory support, vasopressor treatment, or a new renal replacement treatment due to acute organ failure, they were excluded from examination. While exam volunteers, on-site exam staff, clinical providers, and scientists were masked in relation to study assignments, an unmasked pharmacist prepared the investigational drug.
The main outcome of the studies was sustained recovery time from COVID-19 to day 90, which was described as 14 consecutive days at home after hospital discharge, with co-primary testing for the entire cohort and patients negative for neutralizing antibodies. entrance. The modified intention-to-treat population, consisting of patients who gained a total or partial infusion of tixagevimab-cilgavimab or placebo, used for efficacy and protection reviews. current.
The effects of the study demonstrated that 1455 patients were randomly assigned between February 10 and September 30, 2021 for research. The number one intention-to-treat population changed included 1417 patients. Of these, 710 were infused with tixagevimab-cilgavimab and 707 with placebo.
At day 90 in the entire cohort, the estimated cumulative incidence of persistent cure of SARS-CoV-2 was 89% and 86% for subjects in the tixagevimab-cilgavimab and placebo cohorts, respectively. In the HIV-negative subset, the effects were comparable.
Compared to the placebo organization, which had a mortality rate of 12%, the mortality rate of the tixagevimab-cilgavimab organization was 9%. 212, or 30%, of participants in the placebo cohort. In addition, 34 to 5% of subjects in the tixagevimab-cilgavimab arm and 38 or 5% of those in the placebo cohort experienced significant adverse effects.
Overall, the authors noted that the combination of tixagevimab and cilgavimab did not improve the number one final results of persistent recovery time, was safe, and mortality decreased in hospitalized patients with COVID-19 who received remdesivir and other traditional therapies.
The effects of the study demonstrated that among hospitalized patients with COVID-19 who received remdesivir and other classical therapies, tixagevimab-cilgavimab did not serve the primary purpose of sustainable patient recovery. However, it was safe and resulted in clinically significant relief in mortality, i. e. 30%.
Patients who required non-invasive mechanical ventilation or high-throughput oxygen at study access and those who had the SARS-CoV-2 Delta variant of infection had a numerically higher mortality signal. There was no variation in the effects of the studies on the efficacy or serologically regarded protection of endogenous neutralizing antibodies, unlike some previous monoclonal antibody investigations.
Taken together, these charts illustrated that hospitalized patients with COVID-19 can also enjoy better clinical benefits with a single intravenous dose of tixagevimab-cilgavimab in addition to a popular new treatment. Since the mortality relief observed in this trial was a secondary endpoint, more validation is needed. The team discussed that antibody testing would possibly not be mandatory to administer this remedy because the initial prestige of HIV did not correlate with the results of protection or efficacy.
Written by
Shanet Susan Alex, a physician founded in Kerala, India, holds a PhD in Pharmacy from Kerala University of Health Sciences. Her undergraduate education is in clinical pharmacy and research, and she is passionate about medical writing. Shanet has published articles in the International Journal of Medical Science and Current Research (IJMSCR), International Journal of Pharmacy (IJP) and International Journal of Medical Science and Applied Research (IJMSAR). Outside of work, he enjoys listening to music and watching movies.
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Susan Alex, Shanet. (2022, July 13). The prospective of tixagevimab-cilgavimab for the remedy of hospitalized patients with COVID-19. Actualités-Médical. Extracted on July 13, 2022 from https://www. news-medical. net/news/20220713/La-prospectiva-de-tixagevimabe28093cilgavimab -to-treat-hospitalized-patients-COVID-19. aspx.
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