Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Impact of COVID-19 on the liver and on the care of patients with chronic liver disease, hepatobiliary cancer, and liver transplantation: An updated EASL position paper

“…Tixagevimab plus cilgavimab does appear to remain active against BA.2 [ 175 ] but this combination therapy is currently only authorized for prophylactic use (as of April 2022) [ 175 ]. However, within a trial setting, the TACKLE study assessed the efficacy of tixagevimab plus cilgavimab versus placebo in >900 outpatients with symptomatic COVID-19 for ≤7 days and showed that active treatment reduced progression to severe COVID-19 or death (relative risk reduction 50.5%) [ 176 ]. In addition, Bebtelovimab is active in vitro against most circulating omicron subvariants [ 177 ], but at present there are no efficacy data from placebo-controlled clinical trials.…”

Early treatment to prevent progression of SARS-CoV-2 infection

“…Severe COVID-19 or death occurred in 18 (4%) of 407 treated participants in the tixagevimab–cilgavimab group versus 37 (9%) of 415 treated participants in the placebo group. SARS-CoV-2 can be expected to cause severe disease most frequently in older patients with a variety of comorbidities 2 , 3 , 4 but the mean age of participants in this study was 46·1 years (SD 15·2). 2 Adverse events ascribed to tixagevimab–cilgavimab were mild, as has been the case for almost all the monoclonal antibodies directed against SARS-CoV-2.…”

“…SARS-CoV-2 can be expected to cause severe disease most frequently in older patients with a variety of comorbidities 2 , 3 , 4 but the mean age of participants in this study was 46·1 years (SD 15·2). 2 Adverse events ascribed to tixagevimab–cilgavimab were mild, as has been the case for almost all the monoclonal antibodies directed against SARS-CoV-2. 2 …”

“… 2 Adverse events ascribed to tixagevimab–cilgavimab were mild, as has been the case for almost all the monoclonal antibodies directed against SARS-CoV-2. 2 …”

“…In The Lancet Respiratory Medicine , Hugh Montgomery and colleagues 2 report the use of a combination of monoclonal antibodies, tixagevimab and cilgavimab, to prevent the progression of SARS-CoV-2 infection. In a double-blind, randomised controlled trial, unvaccinated patients with documented SARS-CoV-2 infection were randomly assigned to receive 600 mg tixagevimab–cilgavimab intramuscularly within 7 days of onset of COVID-19 symptoms (n=456) or a placebo injection (n=454).…”