Treatment with a single intramuscular (IM) injection of adintrevimab provides protection against severe outcomes with minimal safety concerns among high-risk ambulatory patients with mild to moderate COVID-19 infection due to non-Omicron variants, according to study results published in Open Forum Infectious Disease.
A phase 2/3, multicenter, double-blind, randomized, placebo-controlled trial was conducted between August 2021 and January 2022. Eligible patients (n=399) were aged 12 years and older with mild to moderate COVID-19 infection who were unvaccinated and had at least 1 risk factor for disease progression. Researchers randomly assigned patients 1:1 to receive either a 300-mg IM injection of adintrevimab (n= 198) or placebo (n= 201). The primary efficacy endpoint was the incidence of COVID-19-related hospitalization or all-cause mortality through day 29.
Among patients included in the full analysis, the median age was 57 (range, 18-93) years, 27.7% were older than 65 years, 27.1% had preexisting immunity, and 48.5% had moderate COVID-19 severity. The median time from symptom onset to adintrevimab administration was 2 (range, 0-5) days. Of patients (n=63) with COVID-19 infection due to whole-genome sequencing-confirmed or suspected Omicron variants, the median age was 38 (range, 15-91) years, and 1 patient was younger than 18 years.
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By day 29, receipt of adintrevimab was associated with a 66% relative risk reduction in COVID-19-related hospitalization or all-cause mortality in patients infected with non-Omicron variants, with a standardized risk difference between adintrevimab and placebo of -8.7% (95% CI, -14.7 to -2.7; P =.0047).
Irrespective of age, sex, BMI, baseline serology status, disease severity, and comorbidities, the incidence of COVID-19-related hospitalization or all-cause mortality through day 29 was lower with adintrevimab vs placebo. Of the 63 patients with confirmed or suspected Omicron variant infection, COVID-19-related hospitalization or all-cause mortality occurred among none of the adintrevimab recipients and 2 of the placebo recipients (both hospitalizations).
Analysis of saliva samples collected at baseline through day 29 showed statistically significantly greater reductions in SARS-CoV-2 viral load among patients who received adintrevimab vs placebo at days 5 and 7 (both P <.05). Additionally, patients in the adintrevimab group had a shorter median time to sustained COVID-19 resolution than those in the placebo group (13 vs 16 days, respectively; hazard ratio, 1.255; P =.0781).
The most frequently reported adverse events among patients who received adintrevimab vs placebo were injection-site pain (12% vs 8%), COVID-19 pneumonia (4.2% vs 12%), and injection-site erythema (1.6% vs 3%).
Limitations of this study include that data were insufficient for meaningful analysis of exploratory endpoints, the lack of racial diversity, and the limited number of immunocompromised patients.
“These data support the continued development of monoclonal antibodies for the treatment of COVID-19, particularly for vulnerable populations with limited options” the researchers noted.
Disclosure: Multiple authors declared affiliations with pharmaceutical, biotech, and/or device companies. Please see the original reference for a full list of disclosures.
References
Ison M, Popejoy M, Evgeniev N et al; on behalf of the STAMP Study Group. Efficacy and safety of adintrevimab (ADG20) for the treatment of high-risk ambulatory patients with mild or moderate COVID-19: results from a phase 2/3, randomized, placebo-controlled trial (STAMP) conducted during Delta predominance and early emergence of omicron. Open Forum Infect Dis. Published online May 24, 2023. doi:10.1093/ofid/ofad279
This article originally appeared on Infectious Disease Advisor
