WUSM Servers as Coordinating Center for Global CROWN CORONATION Study Investigating Chloroquine on Front-Line Health Workers & COVID-19

May 20, 2020 | Bill & Melinda Gates Foundation, Chloroquine, Coronavirus, COVID-19, COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative, COVID-19 Therapeutics Accelerator, SARS-CoV-2, Washington University School of Medicine

WUSM Servers as Coordinating Center for Global CROWN CORONATION Study Investigating Chloroquine on Front-Line Health Workers & COVID-19

An international group of physicians and scientists has established a research network to evaluate promising therapies targeting SARS-CoV-2, the virus behind the COVID-19 pandemic. Called the COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative, the group seeks to test whether the antimalarial drug chloroquine can prevent COVID-19 infection or decrease its severity in front-line health-care workers. They are following other prominent groups in the world, such as Oxford’s COPCOV study that conducting similar large-scale studies with the same drug. In this study, up to 30,000 participants will join the effort called the CROWN CORONATION trial. Washington University School of Medicine serves the entire effort as the central clinical coordinating center for this ambitious international clinical trial.

TrialSite News follows up on a recent article authored by Jim Dryden writing for Washington University School of Medicine’s News Hub.

Who is funding this ambitious global clinical trial? And Why?

The study is funded by the COVID-19 Therapeutics Accelerator, which represents the coming together of the Bill & Melinda Gates Foundation along with Wellcome and Mastercard. 

The group came together to bring effective, accessible COVID-19 treatments to market as quickly as possible.

What is the operating hypothesis of this clinical trial?

Laurence Lovat, M, PhD, professor of gastroenterology and biophotonics at University College London leads the study from the UK and commented, “Our hypothesis is that chloroquine may decrease the COVID-19 burden by decreasing entry of the novel coronavirus into host cells and by inhibiting viral replication.” Professor Lovat continued, “Furthermore, with its anti-inflammatory properties, chloroquine might dampen the exaggerated and unregulated immune response in the host, which is often responsible for the unpredictable and severe complications of COVID-19.”

How much are these organizations putting up for clinical research?

The Gates Foundation and Wellcome are each contributing up to $50 million, and the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator. For Gates, this represents part of its up to $100 million commitment to the COVID-19 response.

What is Washington University School of Medicine’s roll?

This prominent Midwest academic medical center will serve as the clinical coordinating center for the international clinical trial.

What is a key goal of this prominent study from Dr. Michael A Avidan of WUSM perspective?

Michael A. Avidan, MD, the Dr. Seymour and Rose T. Brown Professor and head of the Department of Anesthesiology at WUMS and a study principal investigator emphasized the importance of protecting front-line health workers as they face greater risks from contracting the disease from the public. Dr. Avidan noted, “In some places, more than 10% of those who have become infected are health-care workers. There is an urgent need to identify drugs that are effective at preventing infection or mitigating its severity.” Hence, this study emphasizes this critically important, at risk group. Finding ways to protect them from COVI-19 infection offers a substantial public health benefit.

Where will the CROWN Collaborative research investigators be located?

These principal investigators come out of prominent organizations in African, European, North Americans and South Americans countries, including Cameroon, Canada, Ireland, Ghana, Peru, South Africa, Switzerland, the United Kingdom, the United States and Zambia.

What differentiates this study from others?

Well, according to the WUSM news release, first and foremost is its immense size and global reach as well as its use of three different but well-established chloroquine dose schedules in healthy people. However, other studies are even bigger, such as the Oxford COPCOV study focusing on up to 40,000 front-line health-care workers primarily in Asia.

How is the study organized? And what is the Primary goal?

The study sponsors will divide health-care worker participants randomly into four groups. Three of the groups will receive chloroquine at various doses while the fourth group will receive an inactive placebo. Hence, the study team wants to understand if the drug can prevent health-care workers from developing COVID-19 disease or decrease the severity of illness for those who do become infected.

Moreover, the study team seeks to better understand what the lowest dose would be required to offer a benefit with chloroquine. There are limited supplies of chloroquine and the drug can produce side effects. Hence, the study team can show tremendous potential if lower doses of chloroquine can actually produce health benefits.

How long will the participants take chloroquine or the placebo?

Health care workers will take chloroquine or placebo for the first three months and will be monitored for another two months.

How long will the study last?

5 months

Who is ineligible?

Those who are previously infected with COVID-19 or those who have underlying medical problems that are deemed a risk, such as heart ailments.

Where will data from the trial site be compiled?

University College London

Who leads the UK study team?

Laurence Lovat, M. PhD, professor of gastroenterology and biophotonics

Why is the study so important to Africa?

Many nations in the African region represent economically challenged environments not to mention shortages in key health workforce. If the health-care labor pool in Africa isn’t protected then a dire situation could result. But if it turns out the chloroquine can protect an engaged health-care workforce in Africa, this could be a huge win for the continent.

Lead Principal Investigators?

Michael A. Avidan, MD, the Dr. Seymour and Rose T. Brown Professor and head of the Department of Anesthesiology at WUMS

Laurence Lovat, M. PhD, professor of gastroenterology and biophotonics

Ramani Moonesinghe, MD, professor of perioperative medicine at University College London

Helen Rees, MD, executive director of the Wits Reproductive Health and HIV Institute in Johannesburg

Other investigators from Washington University

Mary Politi, PhD, a professor of surgery in the Division of Public Health Sciences; Erik Dubberke, MD, and Elvin Geng, MD, both professors of medicine in the Division of Infectious Diseases; and Graham Colditz, MD, DrPh, the Niess-Gain Professor of Surgery and director of the Division of Public Health Sciences; George Kyei, MD, PhD, an assistant professor of medicine in the Division of Infectious Diseases; Victor Davila-Roman, MD, a professor of medicine, of anesthesiology and of radiology and associate director of the Center for Global Health in the Institute for Public Health.

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