# Studies on the effects of colchicine on neutrophil biology in acute myocardial infarction

> **NIH NIH R01** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $836,425

## Abstract

Abstract
The severe acute respiratory syndrome coronavirus 2, which causes the highly contagious coronavirus disease
2019 (COVID-19), has resulted in a global pandemic. COVID-19 cases in the New York City (NYC) tri-state
area continue to rise exponentially and the region is now the epicenter of the crisis in the United States. In
NYC alone, there are over 21,000 cases (~40% ≥40 years of age) as of March 26, 2020. Many symptomatic
COVID-19 patients have features of a cytokine storm and/or macrophage activation syndrome, including
elevated levels of interleukin (IL)-6. An overly robust local neutrophil influx may also contribute to the robust
immune response with associated severe cardiopulmonary complications, including acute respiratory distress
syndrome requiring mechanical ventilation and myocarditis with cardiogenic shock. Colchicine is a safe, well-
tolerated anti-inflammatory agent that suppresses the activation of the NLRP3 inflammasome, thereby blocking
conversion of pro-IL-1β to active IL-1β, which leads to secondary reductions in other cytokines including IL-6
along with inhibition of macrophage activation. Colchicine also preferentially accumulates in neutrophils
compared with other inflammatory cells and inhibits chemotaxis, endothelial adhesion, and extravasation of
neutrophils at sites of endothelial or tissue inflammation. The effects of colchicine in preventing the cytokine
storm and/or macrophage activation syndrome that leads to clinical deterioration in COVID-19, however, is not
known. Colchicine is not known to inhibit acquired immunity, and is not contraindicated in patients with
infection.
The COLCORONA study is a Canadian government-funded randomized trial of colchicine vs. placebo for 30
days in 6,000 non-hospitalized subjects 40 years of age with COVID-19 diagnosis and at least one high-risk
criterion. This proposal leverages the COLCORONA Trial infrastructure and pragmatic study design with virtual
consent, randomization, and follow-up to rapidly implement the COLCORONA-NYC Study and allow potential
eligible subjects in the NYC tri-state area to participate. The overall aim of the study is to determine the effect
of colchicine on the composite of death or the need for hospitalization in non-hospitalized adults with COVID-
19. The data collected through the COLCORONA-NYC study will provide novel data on treatment of COVID-19
patients, and have public health implications beyond the scope of the current application, including the
potential reduction in the healthcare resources heavily used in COVID-19 (e.g., hospital beds, ventilators), and
potential future use in other infectious causes of acute respiratory distress syndrome.

## Key facts

- **NIH application ID:** 10135209
- **Project number:** 3R01HL146206-02S1
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Binita Shah
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $836,425
- **Award type:** 3
- **Project period:** 2020-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10135209

## Citation

> US National Institutes of Health, RePORTER application 10135209, Studies on the effects of colchicine on neutrophil biology in acute myocardial infarction (3R01HL146206-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10135209. Licensed CC0.

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