NCT04790786
UPMC OPTIMISE-C19 Trial, a COVID-19 Study
Ran, enrolled patients, then stopped for a reason unrelated to the science — flagged as possibly worth a second look.
- Phase
- PHASE4
- Enrollment
- 4,571
- Sponsor class
- OTHER
- Taxonomy code
- regulatory_conduct
What the registry says
“Emergency Use Authorizations for monoclonal antibodies withdrawn”
What real verification found
This record appears to be a misclassification by the pipeline. The trial DID answer its scientific question before being terminated, and results were published, contrary to the "unanswered problem" premise for Category A. 1. Publication: The trial's own comparative-effectiveness results were published as Huang DT, McCreary EK, et al., "Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge: A Cohort Study and Randomized Comparative Effectiveness Trial," JAMA Network Open 2022;5(7):e2220957 (PMC10881222). I fetched the full text and confirmed it explicitly cites NCT04790786/OPTIMISE-C19 as its trial registration. Findings: in the cohort arm, casirivimab-imdevimab showed a 69% reduction and sotrovimab a 40% reduction in hospitalization/death vs. no treatment; in the randomized comparison, the two drugs performed similarly (median 28 hospital-free days each), with a subgroup signal favoring casirivimab-imdevimab in infusion-center settings. A second paper, McCreary EK et al., "The comparative effectiveness of COVID-19 monoclonal antibodies," Contemporary Clinical Trials 2022;119:106822, also came out of this platform trial's broader program. 2. CT.gov itself confirms hasResults=true with a structured results section (arm-by-arm 28-day mortality: bamlanivimab 1/128, casirivimab-imdevimab 12/2454, bamlanivimab-etesevimab 7/885, sotrovimab 7/1104), and lists 4 linked references including the JAMA Network Open paper and two Cochrane systematic reviews (Hirsch 2022, Kreuzberger 2021) synthesizing monoclonal-antibody evidence class-wide. 3. Class-wide mootness: the underlying "which mAb works best" question for this drug generation was independently overtaken by Omicron-driven immune escape — this is precisely why EUAs were withdrawn (the why_stopped text) and is documented in follow-on literature (e.g., bebtelovimab-era studies, "Change in Effectiveness of Sotrovimab... During the Omicron era"). So even beyond the trial's own publication, the comparative question for that antibody generation is now moot due to viral evolution, not unanswered. Net: this was not a case where a real trial's question went unanswered because of a non-scientific stop reason — the trial produced and published real comparative results, and the broader clinical question was further closed off by later variant-driven obsolescence of the entire drug class.
Full search & fetch trail
WebSearch: "NCT04790786 OPTIMISE-C19"; WebSearch: "OPTIMISE-C19 UPMC monoclonal antibody trial results publication"; WebSearch: "OPTIMISE-C19 trial results JAMA sotrovimab bebtelovimab bamlanivimab comparative effectiveness"; WebSearch: "McCreary OPTIMISE-C19 published results 2022 2023"; WebFetch clinicaltrials.gov/study/NCT04790786 (failed, sparse content); WebFetch clinicaltrials.gov API v2 study record (succeeded, got hasResults=true, why_stopped, 4 references, structured results table); WebFetch pubmed.ncbi.nlm.nih.gov/36324319 (bebtelovimab retrospective study — confirmed NOT related to this trial, false lead ruled out); WebSearch: '"OPTIMISE-C19" JAMA Network Open casirivimab sotrovimab Delta variant McCreary Huang'; WebFetch pmc.ncbi.nlm.nih.gov/articles/PMC10881222 (confirmed JAMA Netw Open paper explicitly cites NCT04790786 and reports the trial's randomized comparative results).