# Colorado Clinical and Transational Sciences Institute

> **NIH NIH UL1** · UNIVERSITY OF COLORADO DENVER · 2021 · $3,249,905

## Abstract

PROJECT SUMMARY
Implementation of early and effective treatment for high-risk COVID-19 patients in the outpatient setting is an
important public health tool to prevent healthcare systems from reaching a breaking point by enhancing early
recovery and reducing hospitalizations. In early clinical trials, two neutralizing monoclonal antibody (nMAb)
treatments, bamlanivimab and casirivimab/imdevimab, significantly reduced viral load, symptoms, and
hospitalizations, leading the U.S. Food and Drug Administration to issue Emergency Use Authorizations for
these agents in high-risk COVID-19 outpatients. Unfortunately, only a small fraction (<5%) of eligible
outpatients are currently accessing nMAb treatment due to a number of logistical barriers and clinicians who
are not aware or convinced of its therapeutic benefit. The medical and public health communities desperately
need scalable solutions for rapid and equitable use of outpatient nMAbs, while simultaneously providing real-
world confirmatory evidence of their effectiveness. The State of Colorado implemented a statewide random
allocation system for nMAb allocation to eligible patients, the only state with such a system. Building on robust
dissemination to enhance uptake of nMAb treatment, this random allocation system will facilitate rapid
evaluation of real-world effectiveness of these novel treatments on clinically important, patient-centered
outcomes, through a time-sensitive natural experiment. This project uses a type 2 hybrid implementation-
effectiveness design to achieve the following specific aims: 1) Assess barriers and facilitators to use of nMAbs
statewide, based on diffusion of innovations theory; 2) Develop, implement, and evaluate statewide strategies
to optimize equitable nMAb access; and 3) Determine the real-world effectiveness and safety of nMAb
treatment in high-risk COVID-19 outpatients. The approach will combine cutting-edge dissemination and
implementation methods with a unique natural experiment leveraging the state random allocation system,
along with with electronic health record, patient survey, and administrative claims data. This CTSA
Administrative Supplement will provide urgently needed real-world T4 translational evidence for nMAb
treatment and inform rapid dissemination of current and future outpatient COVID-19 therapies. The
deliverables will advance `designing for dissemination' concepts; address pressing concerns to help patients
and clinicians manage issues of uncertainty, risk, and urgency; and create a model for rapidly generating high
quality real-world evidence in infectious disease pandemics and other future public health emergencies.

## Key facts

- **NIH application ID:** 10402976
- **Project number:** 3UL1TR002535-04S2
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** RONALD J. SOKOL
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $3,249,905
- **Award type:** 3
- **Project period:** 2018-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10402976

## Citation

> US National Institutes of Health, RePORTER application 10402976, Colorado Clinical and Transational Sciences Institute (3UL1TR002535-04S2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10402976. Licensed CC0.

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