Evidence map›Paper›PMID 35697146›Full record

Trial reportContemporary clinical trials2022

The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial.

Erin K McCreary, J Ryan Bariola, Tami E Minnier, Richard J Wadas, Judith A Shovel, Debbie Albin, Oscar C Marroquin, Kevin E Kip, Kevin Collins, Mark Schmidhofer and 31 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialAdaptive Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04790786 (The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 9% of its field
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.

NCT04790786 phase4terminatednot on this map

The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial

TypeinterventionalSponsorErin McCrearyRan2021 to 2022Enrolled4,571ConditionsCovid19ArmsLilly Bamlanivimab, Regeneron Casirivimab + Imdevimab, Lilly Bamlanivimab + Etesevimab, Sotrovimab, Bebtelovimab
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  4. Article
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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

41 authors at 3 institutions in 1 country.

Erin K McCrearyDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
J Ryan BariolaDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Tami E MinnierWolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Richard J WadasDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Judith A ShovelWolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Debbie AlbinSupply Chain Management/HC Pharmacy, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Oscar C MarroquinClinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Kevin E KipClinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Kevin CollinsClinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Mark SchmidhoferDivision of Cardiology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Mary Kay WisniewskiWolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
David A NaceDivision of Geriatric Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Colleen SullivanClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Meredith AxeDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Russell MeyersDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Alexandra WeissmanDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
William GarrardClinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Octavia M Peck-PalmerDepartment of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Alan WellsDepartment of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Robert D BartHealth Services Division, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Anne YangDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Lindsay R BerryBerry Consultants, Austin, TX, USA.
Scott BerryBerry Consultants, Austin, TX, USA.
Amy M CrawfordBerry Consultants, Austin, TX, USA.
Anna McGlothlinBerry Consultants, Austin, TX, USA.
Tina KhademHealth System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Kelsey LinstrumClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Stephanie K MontgomeryClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Daniel RickettsClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Jason N KennedyClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Caroline J PidroClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Ghady HaidarDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Graham M SnyderDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Bryan J McVerryDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Donald M YealyDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Derek C AngusClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Anna NakayamaHealth System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Rachel L ZapfWolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Paula L KipWolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Christopher W SeymourClinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
David T HuangDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: huangdt@upmc.edu.
University of Pittsburgh · USUniversity of Pittsburgh Medical Center · USBerry & Associates (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoclonal antibodies (mAb) that neutralize SARS-CoV-2 decrease hospitalization and death compared to placebo in patients with mild to moderate COVID-19; however, comparative effectiveness is unknown. We report the comparative effectiveness of bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab.

methodsA learning health system platform trial in a U.S. health system enrolled patients meeting mAb Emergency Use Authorization criteria. An electronic health record-embedded application linked local mAb inventory to patient encounters and provided random mAb allocation. Primary outcome was hospital-free days to day 28. Primary analysis was a Bayesian model adjusting for treatment location, age, sex, and time. Inferiority was defined as 99% posterior probability of an odds ratio < 1. Equivalence was defined as 95% posterior probability the odds ratio is within a given bound.

findingsBetween March 10 and June 25, 2021, 1935 patients received treatment. Median hospital-free days were 28 (IQR 28, 28) for each mAb. Mortality was 0.8% (1/128), 0.8% (7/885), and 0.7% (6/922) for bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab, respectively. Relative to casirivimab-imdevimab (n = 922), median adjusted odds ratios were 0.58 (95% credible interval [CI] 0.30-1.16) and 0.94 (95% CI 0.72-1.24) for bamlanivimab (n = 128) and bamlanivimab-etesevimab (n = 885), respectively. These odds ratios yielded 91% and 94% probabilities of inferiority of bamlanivimab versus bamlanivimab-etesevimab and casirivimab-imdevimab, and an 86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab.

interpretationAmong patients with mild to moderate COVID-19, bamlanivimab-etesevimab or casirivimab-imdevimab treatment resulted in 86% probability of equivalence. No treatment met prespecified criteria for statistical equivalence. Median hospital-free days to day 28 were 28 (IQR 28, 28) for each mAb. FUNDING AND REGISTRATION: This work received no external funding. The U.S. government provided the reported mAb. This trial is registered at ClinicalTrials.gov, NCT04790786.

Indexed as

COVID-19Learning Health SystemAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingBayes TheoremHumansSARS-CoV-2Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, Neutralizingbamlanivimabcasirivimabetesevimabimdevimab

Identifiers

PMID35697146
PMCPMC9187853
OpenAlexW4282916186

What OpenQuestion holds

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Registered trials

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.