Amubarvimab/romlusevimab for COVID-19: real-time analysis of 6 studies

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Amubarvimab/romlusevimab for COVID-19

4 studies with >1,000 patients

Serious outcome risk

Amubarvimab/romlusevimab

Control

Significantly lower risk for viral clearance.

Efficacy is variant dependent.

COVID-19 Amubarvimab/romlusevimab studies · October 2026

Outcome (studies)

Improvement

Relative risk · 95% CI

All studies (4)25%

With exclusions (3)44%

Mortality (4)25%

Hospitalization (2)37%

Viral clearance (2)7%

RCTs (2)61%

RCT mortality (2)61%

Early (1)91%

Late (3)3%

00.511.5+

← Amubarvimab/
romlusevimab
reduces riskIncreased
risk →

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Efficacy is variant dependent. mAb use may create new variants that spread globally1-3, and may be associated with increased risk of autoimmune disease4, prolonged viral loads, clinical deterioration, and immune escape2,5-9. Amubarvimab/romlusevimab was adopted in 1 country.


	Covid Analysis	Amubarvimab/romlusevimab for COVID-19: real-time meta-analysis of 4 studies (Version 4)
	Significantly lower risk is seen for viral clearance. 2 studies from 2 independent teams (both from the same country) show significant benefit. Meta-analysis using the most serious outcome reported shows 25% [-70‑66%] lower ris..
Feb 6 2025	Mourad et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2025.02.002	Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
	54% higher mortality (p=0.19) and 12% higher combined mortality/hospitalization (p=0.53). Analysis of 2,311 hospitalized COVID-19 patients from four randomized controlled trials (ACTIV-3/TICO) showing no significant difference in long-term mortality with sotrovimab, amubarvimab/romlusevimab, tixagevimab-cilgavimab, or ensovibep.
Sep 30 2024	Qu et al., Heliyon, doi:10.1016/j.heliyon.2024.e37663	Effect of amubarvimab-romlusevimab for treatment of severe COVID-19 in intensive care units: A retrospective cohort study
	46% lower mortality (p=0.06) and 4% improved viral clearance (p=0.89). Retrospective 121 severe ICU COVID-19 patients in China showing lower 28-day mortality and ICU mortality with amubarvimab-romlusevimab treatment compared to no antiviral treatment. No significant differences were found in viral conversion..
Aug 16 2024	Evering et al., eClinicalMedicine, doi:10.1016/j.eclinm.2024.102787	Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial
	91% lower mortality (p=0.006), 20% higher long COVID (p=0.39), 61% lower hospitalization (p=0.0008), and 67% lower combined mortality/hospitalization (p<0.0001). RCT 780 high-risk non-hospitalized COVID-19 patients showing significantly lower risk of hospitalization or death through 36 weeks, but no significant difference in long COVID with amubarvimab/romlusevimab treatment compared to placebo.
Aug 11 2024	Focosi, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268	Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities
	Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date.
Aug 8 2024	Casadevall et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408	Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship
	Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod..
Apr 19 2024	Yalan et al., BMC Pharmacology and Toxicology, doi:10.1186/s40360-024-00753-7	Treatment for Covid-19 with SARS-CoV-2 neutralizing antibody BRII-196(Ambavirumab) plus BRII-198(Lomisivir): a retrospective cohort study
	71% higher mortality (p=0.35), 8% higher ICU admission (p=0.8), 8% shorter hospitalization (p=0.004), and 7% faster viral clearance (p=0.004). Retrospective 340 COVID-19 patients in China showing shorter length of hospital stay and faster viral clearance with BRII-196 plus BRII-198 monoclonal antibody treatment, especially when given early. The treatment did not show efficacy fo..
Sep 6 2022	Hao et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.983505	Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults
	Phase 1 RCT with 44 healthy adults showing BRII-196 and BRII-198 monoclonal antibodies, alone or in combination, were safe and well-tolerated up to the highest doses tested of 3,000 mg for single mAbs and 1500/1500 mg for the combination...
Dec 23 2021	Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9	Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
	15% higher mortality (p=0.72) and 7% improved recovery (p=0.48). RCT with 182 sotrovimab patients, 176 BRII-196+BRII-198 patients, and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility. Long-term results are reported in [Mou..