Bamlanivimab Flops in COVID-19 Hospital patients

Administration of bamlanivimab (formerly LY-CoV555), a monoclonal antibody for COVID-19, combined with remdesivir (Veklury) was ineffective for hospitalized patients with COVID-19, a randomized trial found.

There was no significant difference in sustained recovery over a 90-day period with the combination compared with remdesivir plus placebo (rate ratio 1.06, 95% CI 0.77–1.47), said Jens Lundgren, MD, University Copenhagen in Denmark, and colleagues.

Moreover, there was no significant difference in the main safety outcome. The rate of adverse outcome (death, adverse events, or stage 3 and 4 clinical adverse effects through day 5) was 19% in the study arm versus 14% in the placebo arm (NO 1.56, 95% CI 0.78-3.10, P.= 0.20), the authors wrote in the New England Journal of Medicine.

As previously reported, the lawsuit was halted in mid – October due to potential safety concerns in this population. The authors noted that a data and safety audit board suspended registration for admission after 314 patients. A statement from the National Institutes of Health, which supported the so-called ACTIV-3 trial, said the lawsuit was closed to new registrants on Oct. 26.

Bamlanivimab was approved in November by the FDA for use in COVID-19 patients with moderate to severe disease who were at high risk of progressing to severe disease, but the group stressed that the drug was not to be used for patients with true COVID-19 or for those requiring oxygen therapy.

ACTIV-3 (Accelerated COVID-19 Therapeutic Interventions and Vaccines) was designed for early assessment of future and safety after 300 patients, and then enrollment to the full sample size for representatives who pass that initial assessment. Eligible patients were hospitalized adults with COVID-19 with a symptom duration of 12 days or less.

From 5 August to 13 October, 326 patients were enrolled at 31 sites, including 23 in the US, seven in Denmark and one in Singapore. In total, 163 patients received an infusion of bamlanivimab, and 151 received an infusion of placebo. All patients received remdesivir, as well as additional oxygen and glucocorticoids when prescribed. Almost all patients (95%) received remdesivir, the authors noted.

The median age was 61, 44% were female, 47% white, 21% black, and 24% Hispanic. About half of them had a BMI over 30, and 68% had a concomitant illness, including about half with major allergies that required medication.

Although the main outcome was a steady recovery over a 90-day period, an interim income assessment was performed based on a seven-segment order scale for lung function, which did not show a significant difference between the bamlanivimab groups. and placebo (NO 0.85, 95% CI 0.56–1.29, P.= 0.45).

An equal percentage of patients developed organ dysfunction and malignancy (16% in the intervention group vs. 14% in the placebo group).

Studying safety over 28 days, a major safety event occurred in 23% of the intervention group and 20% of the placebo group. There were 14 deaths – nine in the intervention group and five in the placebo, 12 of 14 of which were due to exacerbation by COVID-19.

One limitation to these key findings with a median of just 31 days of follow-up is that the safety of bamlanivimab versus placebo is “still uncertain,” partly due to smaller sample sizes and shorter follow-up times leading to periods of confidence. around key safety outcomes.

“These results indicate a low likelihood that LY-CoV555 improves outcomes among hospitalized patients with COVID-19,” the authors wrote.