Evidence map›Paper›PMID 40893477›Full record

ArticleNew microbes and new infections2025

An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity.

Isabel H Gonzalez-Bocco, Rayven Frierson, Alyssa Cho, Fabiola A Reyes Curcio, Andres E Franceschi, Chloe Lahoud, Dimitrios G Moshovitis, Katherine Beluch, Manu Balusu, C Elizabeth Keleher and 11 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in New microbes and new infections, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Isabel H Gonzalez-BoccoDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Rayven FriersonDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Alyssa ChoDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Fabiola A Reyes CurcioTufts Medical Center, Boston, MA, USA.
Andres E FranceschiDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Chloe LahoudDepartment of Internal Medicine, Staten Island University Hospital, New York, USA.
Dimitrios G MoshovitisDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Katherine BeluchHospital of University of Pennsylvania, Philadelphia, USA.
Manu BalusuSaint Clare and Saint Mary Hospital, Passaic, NJ, USA.
C Elizabeth KeleherGastroenterology Department, Massachusetts General Hospital, Boston, MA, USA.
Keri M SullivanGastroenterology Department, Massachusetts General Hospital, Boston, MA, USA.
Michael DouganHarvard Medical School, Boston, MA, USA.
Qianwen WangGlaxoSmithKline, London, UK.
Jennifer H HanGlaxoSmithKline, Collegeville, PA, USA.
Ahmed NaderGlaxoSmithKline, Collegeville, PA, USA.
Alicia AylottGlaxoSmithKline, Stevenage, UK.
Wei WangHarvard Medical School, Boston, MA, USA.
Brian T ChanDivision of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA.
Sarah P HammondDivision of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA.
Jennifer Manne-GoehlerDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Sophia KooDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Immunocompromised individuals have a limited humoral immune response to SARS-CoV-2 vaccination and are at higher risk of severe COVID-19. Sotrovimab is a monoclonal antibody (mAb) targeting a conserved SARS-CoV-2 spike protein epitope. Methods: This phase II open-label study evaluated the safety and tolerability of sotrovimab pre-exposure prophylaxis in immunocompromised adults with impaired vaccine response. Between February and June 2022 in the northeastern region of the USA, participants received sotrovimab 500 mg IV on Treatment Day (TD) 1 and 2000 mg IV on TD2 due to the spread of the Omicron BA.2 subvariant. Follow-up lasted 36 weeks (∼5 half-lives), assessing safety and tolerability, PK, COVID-19 incidence and severity, and quality of life. Results: Ninety-three subjects received 500 mg on TD1, of whom 81 received 2000 mg on TD2. Three patients reported five drug-related adverse events, four grade 2 infusion-related reactions and one grade 2 headache, all resolving quickly. Among 35 SARS-CoV-2 cases, 94 % had no activity limitations or hospitalizations per the National Institute of Allergy and Infectious Diseases Ordinal Scale. Sotrovimab exhibited dose-dependent increases in exposures at doses of 500 mg and 2000 mg. Conclusion: Sotrovimab pre-exposure prophylaxis had a favorable safety profile and was well tolerated at both doses, with low immunogenicity. These findings support mAbs' safety as COVID-19 pre-exposure prophylaxis in this population.

Indexed as

Covid-19Immunocompromised hostMonoclonal antibodiesPre-exposure prophylaxis

Identifiers

PMID40893477
PMCPMC12395066

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.