The University of Oxford plans a large-scale clinical trial to test the use of Hydroxychloroquine on up to 40,000 healthcare participants at between 50 to 100 sites. Hydroxychloroquine has been touted by, among others, U.S. President Donald Trump as a ‘game changer,’ and the prestigious UK institution now will assess the evidence based on a randomized controlled trial. Does Hydroxychloroquine help treat SARS-CoV-2? This University of Oxford-based team aims to find out.

Background

The  “COPCOV” study will be led by scientists from the University of Oxford while funding originates from the Wellcome Trust. The study will pool resources of international experts across multiple continents. COPCOV represents  the largest interventional COVID-19 trial in the world involving up to 40,000 frontline healthcare workers.

The Study

The study is a double-blind, randomized, placebo-controlled trial that is planned for actual health care settings (e.g. health systems, hospitals, clinics, etc.). The research units will first and foremost seek informed consent, vital for adherence to good clinical practices. Thereafter investigators will recruit healthcare workers or other individuals at significant risk who can be followed reliably for five months. The sponsor seeks to study 40,000 participants and they predict an average of 400-800 participants per site in 50-100 sites. The stud commences on April 2020 and will run for one year till April 2021.

Study Protocol

Participants will be randomized to receive either chloroquine/hydroxychloroquine or placebo (1:1 randomization). A loading dose of 10mg base/kg, followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg hydroxychloroquine sulphate) will be taken for 3 months. Thereafter the investigators will record during follow up visits any subsequent episodes of symptomatic respiratory illness, such as symptomatic COVID-19 clinical outcomes, and asymptomatic infection with the virus causing COVID-19. If the participants are in fact diagnosed with COVID-19 during the period of treatment, they will continue the study treatment unless advised to do so by their healthcare professional until they run out of their current supply of study drug or placebo at home. They will not collect more thereafter. Once done participants will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days).

Study Sites

As the Mahidol Oxford Tropical Medicine Research Unit in Thailand is helping to spearhead the study, a number of sites will be available in Southeast Asia and India. See the map and link to actual site names.

Contribution from Indian Drug Maker

An Indian company called Intas Pharmaceuticals Ltd will donate up to two million tablets of the hydroxychloroquine for this massive worldwide clinical trial—enabling the largest interventional COVID-19 trial in the world involving up to 40,000 frontline healthcare workers. Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world according to their website. They crossed the $1.9 billion mark in the past year. They are reported to rank 8th in the Indian pharmaceutical market and is the largest privately owned generic pharmaceutical company.

Principal Investigator Comment

Dr. William Schilling, co-lead investigator, Research Physician and Infectious Diseases/Microbiology Registrar, Mahidol Oxford Tropical Medicine Research Unit, Thailand noted what prompted the rapid initiation of this global clinical trial: “We are in a race against time to find effective treatments and preventive measures as the COVID-19 pandemic grows. What we already know is that chloroquine has antiviral activity against SARS-CoV-2 in cell culture, as it does for the related SARS-CoV.”

Lead Research/Investigator

Dr. William Schilling, co-lead investigator, Research Physician and Infectious Diseases/Microbiology Registrar, Mahidol Oxford Tropical Medicine Research Unit, Thailand

Call to Action: Interested in this study?  It is being led by the MORU Tropical Health Network

Source: ClinicalTrials.gov

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