Evidence map›Paper›PMID 34896293›Full record

Trial reportContemporary clinical trials2022

Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days.

Erin K McCreary, J Ryan Bariola, Tami Minnier, Richard J Wadas, Judith A Shovel, Debbie Albin, Oscar C Marroquin, Mark Schmidhofer, Mary Kay Wisniewski, David A Nace and 17 more

Abstract readClinical TrialAdaptive Clinical Trial
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. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. 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

27 authors.

Erin K McCrearyDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: mccrearye3@upmc.edu.
J Ryan BariolaDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Tami MinnierWolff Center, UPMC, Pittsburgh, PA, USA.
Richard J WadasDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Judith A ShovelWolff Center, UPMC, Pittsburgh, PA, USA.
Debbie AlbinUPMC Supply Chain Management/HC Pharmacy, UPMC, Pittsburgh, PA, USA.
Oscar C MarroquinClinical Analytics, UPMC, Pittsburgh, PA, USA.
Mark SchmidhoferDivision of Cardiology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Mary Kay WisniewskiWolff Center, UPMC, 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.
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.
Tina KhademDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
William GarrardClinical Analytics, UPMC, Pittsburgh, PA, USA.
Kevin CollinsClinical Analytics, UPMC, Pittsburgh, PA, USA.
Alan WellsDepartment of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Robert D BartUPMC Health Services Division, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, 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; UPMC Health System Office of Healthcare Innovation, 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; UPMC Health System Office of Healthcare Innovation, 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 McVerryDepartment of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, UPMC, 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; UPMC Health System Office of Healthcare Innovation, Pittsburgh, PA, USA; Department of Critical Care 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.
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.
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; UPMC Health System Office of Healthcare Innovation, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Funding

Sepsis subtypes: biology, treatment, and bedside applicationR35GM119519 · NIGMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Christopher W. Seymour · 2016 to 2026
$4.9M
NIGMS NIH HHS R35 GM119519
6 · The paper itself

Abstract

Outpatient treatments that limit progression to severe coronavirus disease 2019 (COVID-19) are of vital importance to optimise patient outcomes and public health. Monoclonal antibodies (mAb) demonstrated ability to decrease hospitalizations in randomized, clinical trials. However, there are many barriers to mAb treatment such as patient access and clinician education. There are no data comparing efficacy or safety of available mAbs. We sought to rapidly launch an adaptive platform trial with the goals of enhancing access to treatment, regardless of geography and socioeconomic status, and evaluating comparative efficacy and safety of available mAbs. Within 21 days from idea genesis, we allocated mAb treatment to all patients within the context of this clinical trial. Within 2 months, we closed the gap of the likelihood of receiving mAb, conditional on background positivity rate, between Black and White patients (Black patients 0.238; White patients 0.241). We describe trial infrastructure, lessons learned, and future directions for a culture of learning while doing.

Indexed as

Antineoplastic Agents, ImmunologicalCOVID-19Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansSARS-CoV-2Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBamlanivimabCasirivimabCOVID-19EtesevimabImdevimabMonoclonal antibodiesSARS-CoV-2

Identifiers

PMID34896293
PMCPMC8654455

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.