Monoclonal antibody lenzilumab boosts survival in COVID hospital patients
The neutralizing monoclonal antibody lenzilumab significantly raised survival without the use of mechanical ventilation in hospitalized COVID-19 patients and had a good safety profile, according to a phase 3 clinical trial yesterday in The Lancet Respiratory Medicine.
A team led by Mayo Clinic researchers enrolled 520 hospitalized COVID-19 pneumonia patients from 29 sites in the United States and Brazil from May 5, 2020, to Jan 27, 2021; 479 patients were included in a modified intention-to-treat population. Participants were randomly assigned in a 1:1 ratio to receive either three intravenous 600-milligram (mg) doses of lenzilumab or a placebo given 8 hours apart.
Average patient age was 61 years, 65% were men. Steroids were given to 94% of patients, 72% received the antiviral drug remdesivir, and 69% received both therapies.
Of the 236 participants who received lenzilumab, 198 (84%) survived without needing mechanical ventilation, compared with 190 of the 243 (78%) patients in the placebo group. The odds of survival were greater in the lenzilumab group than in the placebo group (hazard ratio, 1.54).
At least one severe, but not life-threatening, adverse event occurred in 68 of 255 patients (27%) of the lenzilumab group and 84 of 257 patients (33%) in the placebo group. Most of these events were related to respiratory disorders (26%) and cardiac conditions (6%).
While lenziilumab improved survival while avoiding mechanical ventilation, the authors said that the added value of lenzilumab (with steroids) beyond that of similar immune-modulating drugs in the treatment of COVID-19 is unknown.
In a related commentary, Helen Leavis, MD, PhD, of Utrecht University in the Netherlands, and colleagues agreed, saying that conducting clinical trials of immune-modulating drugs such as lenzilumab has become increasingly complicated. They noted that the lenzilumab trial didn't allow administration of similar drugs such as tocilizumab and was completed before these drugs were widely used in clinical practice.
"Without knowledge of the added benefit or the added risk of different, concurrently used immunomodulators, trials that do not integrate available standards of care are difficult to interpret," they wrote. "As treatment regimens for COVID-19 constantly change and become more complex, evaluation of interactions must be the goal, and probably requires coordination across clinical trials, industry sponsors, and the involvement of large platform trials."
Dec 1 Lancet Respir Med study and commentary
CDC: Homeless Americans have low COVID-19 vaccination rates
Today in Morbidity and Mortality Weekly Report (MMWR), the Centers for Disease Control and Prevention (CDC) notes that just 19% to 45% of the homeless population in six metropolitan areas were fully vaccinated against COVID-19.
To assess coverage levels, the CDC tracked vaccination coverage from Dec 13, 2020, to Aug 31, 2021, in six US metro areas: Chicago; Minneapolis; Los Angeles; Detroit; Washington, DC; and Fairfax, Virginia.
"In each jurisdiction, full vaccination coverage among persons experiencing homelessness was substantially lower (11.2–37.2 percentage points) than that among the general population of the respective jurisdiction," the CDC said.
Full COVID-19 vaccination coverage among the homeless ranged from 18.6% to 44.5%, compared with 43.6% to 59.8% in the general population of each metro area.
Coverage with at least one COVID-19 vaccine dose ranged from 22.0% to 52.0% among homeless people, and from 46.5% to 65.7% in the respective general populations, the CDC said.
Homeless shelters and other congregate living settings are known sites of COVID-19 outbreaks. Vaccinating the homeless, through pop-up clinics, is an important tool in managing the pandemic, the CDC said.
Dec 3 MMWR report