Publication date: Mar 21, 2025
Monoclonal antibodies have potential as rapidly developable agents for treatment and prevention of emerging viruses. The ACTIV-2 trial randomized persons with mild-moderate COVID-19 to the monoclonal antibody combination tixagevimab/cilgavimab via intramuscular injection (600 mg IM) or infusion (300 mg IV) versus placebo. We present final safety and laboratory outcomes; primary outcomes were previously reported. The analyzed IM group included 214 participants, and the IV group, 106 participants. Adverse events were not different between treatment and placebo. The half-life of both components was >90 days for IM or 75 days for IV. New anti-drug antibodies were about 3 times more likely in active vs. placebo recipients. SARS-CoV-2 neutralizing antibodies increased 157-fold at 7 days and 127-fold at 1 month (IM-treated) but were less robust in IV participants. These data can inform future development of monoclonal antibodies against SARS-CoV-2 and other viruses, even if this intervention is of low utility for contemporary SARS-CoV-2 variants.
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| Concepts | Keywords |
|---|---|
| 300mg | Health sciences |
| Antibodies | Immunology |
| Future | Medical specialty |
| Pharmacokinetics | Medicine |
| Viruses |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | COVID-19 |
| disease | IDO | intervention |
| drug | DRUGBANK | Etodolac |
| disease | MESH | Allergy |
| disease | MESH | Infectious Diseases |
| drug | DRUGBANK | Trestolone |
| disease | IDO | protein |
| disease | MESH | viral infections |
| disease | MESH | symptom burden |
| disease | IDO | history |
| disease | IDO | symptom |
| drug | DRUGBANK | Ranitidine |
| disease | MESH | death |
| disease | MESH | cancer |
| drug | DRUGBANK | Fenamole |
| disease | MESH | inflammation |
| drug | DRUGBANK | Fibrinogen Human |
| disease | IDO | assay |
| drug | DRUGBANK | Lactose |
| drug | DRUGBANK | Prothrombin |
| disease | MESH | cardiac events |
| disease | MESH | chronic conditions |
| disease | MESH | clinical significance |