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Duke Clinical Research Institute (DCRI) is set to conduct a randomised clinical trial of hydroxychloroquine to prevent Covid-19 in healthcare workers at risk of infection.
The Patient-Centered Outcomes Research Institute (PCORI) will provide up to $50m to fund a registry and the clinical trial, which will be powered by health research network PCORnet.
The Healthcare Worker Exposure Response and Outcomes (HERO) research programme is a rapid-response study that aims to collect the safety and efficacy data of hydroxychloroquine in the Covid-19 indication.
DCRI executive and medicine in cardiology professor Adrian Hernandez said: “Although there has been discussion about hydroxychloroquine as a potential prevention for Covid-19, we are lacking the data on safety and efficacy of this therapy.
“By conducting this study with healthcare workers, we are working directly with those who understand the importance of quickly getting answers into the hands of those on the front line.”
The research programme involves national registry and randomised trial parts.
Set to commence enrolment in the coming two weeks, the registry will focus on a large community of healthcare workers at high risk for the novel coronavirus infection.
The randomised clinical trial, named HERO-HCQ, will be initiated this month and aims to enrol 1,500 healthcare workers from the registry. Participants will be given hydroxychloroquine or placebo for one month.
In addition to the drug’s effectiveness in reducing the Covid-19 infection rate, the trial will evaluate its use in preventing the unintentional spread from healthcare workers to others.
DCRI executive and medicine associate professor Susanna Naggie said: “It’s important that we assess the effectiveness of this drug for prophylaxis treatment in healthcare workers, both for their safety and to prevent the further spread of SARS-CoV-2 as they care for patients.
“Furthermore, the HERO registry of healthcare workers will ease study start-up times for future clinical trials that may be carried out for other prevention or treatment strategies.”