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NEW: 25, January, 2021

THE TOGETHER TRIAL: A STUDY TO EVALUATE THERAPEUTICS FOR EARLY INFECTION OF COVID-19

** For immediate release **
Hamilton, Canada – McMaster University, in partnership with the Pontificia Universidade
Católica de Minas Gerais in Brazil and the University of Stellenbosch in South Africa, and with
the support of Cytel Inc., today announces the next stage of the TOGETHER COVID Trial
(www.togethertrial.com). The trial will evaluate the effectiveness of ivermectin, metformin, and
fluvoxamine on preventing disease progression from COVID-19. The TOGETHER Trial builds on
the success of a previous evaluations of hydroxychloroquine and lopinavir/ritonavir.
Although COVID-19 vaccines are being rolled out across Canada, the US and Western Europe,
for low- and middle-income countries, it may be years before vaccines are universally available.
For this the reason, the TOGETHER Trial was created to evaluate the effectiveness of cheap,
widely available drugs in low- and middle-income countries that can be repurposed for COVID-
19.
"The need for treatments in early disease is paramount. Evidence is quickly emerging that
suggests a number of drugs may have a promising effect on reducing COVID-19 disease severity
in patients with mild to moderate disease,” says Dr. Edward Mills, Principal Investigator of the
TOGETHER Trial and Associate Professor in the Faculty of Health Sciences, “our study has been
designed to rapidly recruit patients to evaluate these potential therapeutics.”
At 7 study sites in Minas Gerais, Brazil, hundreds of patients are being recruited every week.
“For Brazil, the high incidence of COVID-19 means many patients are interested in
participating,” says Dr. Gilmar Reis, co-investigator of the TOGETHER Trial and Professor of
Medicine at Pontificia Universidade Católica de Minas Gerais. More than 217,000 Brazilians
have died from COVID-19 since the start of the pandemic.

“There is particularly keen interest in our trial for its evaluation of ivermectin,” adds Dr. Reis.
ivermectin is a cheap drug (less than $5 per treatment) and is on the list of essential medicines
published by the World Health Organization. Ivermectin is typically used to treat parasitic
infections, however emerging evidence from cell studies and small clinical trials may indicate a
benefit for COVID-19 patients with early disease.

Other drugs the TOGETHER Trial is evaluating include metformin, a drug widely used to treat
diabetes and fluvoxamine a selective serotonin reuptake inhibitor (SSRI) commonly used to
treat depression and anxiety disorders.

The TOGETHER Trial is a collaboration of international researchers and includes Dr. Mills, Dr.
Lehana Thabane and Dr. Gordon Guyatt from McMaster University as well co-investigators
from Brazil and South Africa. If the trial is able to recruit patients at the same rate as its first
evaluations, the researchers hope to have results in 2-3 months.
“As the pandemic continues with no end in sight for many low- and middle-income countries,
there is a growing urgency for effective therapies,” says Dr. Mills. “Many countries simply do
not have the healthcare resources to continue the current rate of patients being admitted to
hospital with COVID-19. The TOGETHER Trial hopes to help identify therapies to slow the
pandemic while many countries await the delivery of vaccines.”

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For more information on the TOGETHER Trial:
Contact: Edward Mills, Principal Investigator (millsej@mcmaster.ca) or Jamie Forrest,
TOGETHER Trial Coordinator (jamie.forrest@cytel.com)