Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study
Why this work is in the frame
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Bibliographic record
Abstract
Monoclonal antibodies (mAbs) administered using intramuscular (IM) injections could offer a convenient and accessible therapeutic option. However, there is a paucity of data on IM tolerability by injection site to guide mAb development. This Phase 1, open-label trial randomized healthy adults to receive 62.5 mg/mL sotrovimab IM into each dorsogluteal muscle (2 × 4 mL injections), or 100 mg/mL sotrovimab IM into the dorsogluteal muscle (1 × 5 mL), the anterolateral thigh muscle (1 × 5 mL) or each deltoid muscle (2 × 2.5 mL). Incidence of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs) were assessed, along with patient-reported outcomes (Perception of Injection version 3 questionnaire and Pain-Numeric Rating Scale [Pain-NRS]). Of 329 participants screened, 215 (65%) received sotrovimab (median age 39 [range 19–65] years; 57% female; mean body mass index 25.4 kg/m2). Overall, 46% (n = 99/215) of participants reported AEs; the most common was injection site pain (30%; n = 65/215). There were no SAEs reported, and all AESIs were Grade 1 or 2. Through Day 8, mean Pain-NRS values were < 1 and similar across injection sites; values were highest on Day 1 at 15 minutes post-dosing and decreased over time through Day 8. Injection site reactions were reported by all participants as ‘not at all’ or ‘a little’ bothersome. No or little impact on sleep and movement was reported. Sotrovimab IM was generally well tolerated at all injection sites, at volumes up to 5 mL (dorsogluteal and anterolateral thigh) and as one 2.5 mL injection into each deltoid muscle. To our knowledge, these are the first data to show that a >2 mL mAb injection into each deltoid muscle is well tolerated.Trial registration ClinicalTrials.gov identifier, NCT05280717
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it