A large-scale trial to see whether the malaria drug hydroxychloroquine can prevent health workers from getting coronavirus disease is beginning in the United Kingdom and other countries. This was announced today in a press release from the University of Oxford.
Oxford is leading the UK trial sites for a global study testing if anti-malarial drugs prevent COVID-19 in vital frontline healthcare workers. Find out more: https://t.co/NIAVEWxEVb @OxfordMedSci @OxfordBRC @DrAmandaAdler
— University of Oxford (@UniofOxford) May 21, 2020
The drug has been making media arounds ever since the start of this pandemic and especially now that the United States’ President Donald Trump has announced that he is taking the drug to thwart any coronavirus infection in the future.
Though Trump’s revelation that he was taking the drug has left doctors scratching their heads and telling the public about its dangerous side-effects on the human heart. The two forms of the drug called chloroquine and hydroxychloroquine, both can cause abnormal heart rhythms, especially in people who are overweight and may have diabetes or hypertension.
— CBS News (@CBSNews) May 21, 2020
The French Connection: Trump Family Trusts Are Invested in Hydroxychloroquine Maker https://t.co/80fkXYMxCR
— Cheri Jacobus (@CheriJacobus) May 20, 2020
Though many trials have reported negative results when it comes to the effectiveness of these drugs in preventing the coronavirus infection, right now preventive measures against infection are urgently needed for health care workers on the frontline.
— Health Units (@healthunits) April 21, 2020
With no available vaccine and no effective drug for the treatment of the infection is available, the scientists are going ahead with this trial of 40,000 health care workers to see if it may work.
All these health workers are at high risk of developing coronavirus infection due to the nature of their jobs. Brighton, Sussex University hospitals, and the John Radcliffe hospital in Oxford have already begun enrolling volunteers.
— Lisa Barbour (@LisaBarbour12) May 21, 2020
The study is being led by the Diabetes Trials Unit, in United Kingdom; a part of the Radcliffe Department of Medicine at Oxford University and the Wellcome Trust. It is also being supported by Mahidol Oxford Tropical Medicine Research Unit in Thailand. In Thailand these drugs are already being prescribed to treat malaria. Participants are also being recruited from Europe, Africa, Asia and South America.
The COPCOV study is a double-blind, randomized, placebo-controlled trial that will recruit frontline healthcare workers and staff from Europe, Africa, Asia and South America who have close contact with patients with COVID-19 to determine definitively if chloroquine and hydroxychloroquine are effective in preventing COVID-19.
According to the statement from University of Oxford, any adult that is the part of UK healthcare facility and is working with suspected or conformed COVID-19 cases can participate in the trial. The only reason someone might not be considered might be a possible respiratory infection or a COVID-19 diagnosis.
Anyone who might be enrolled in the study will give informed consent and receive either the malaria drug or a placebo. People in Asia will get chloroquine and people in UK, Europe, and Africa will be given hydroxychloroquine for 3 months. Which half will get the placebo and which half will be given the drug will be randomly selected and neither the scientists nor the subjects will know what anyone is being given.
Massive congratulations to the team for getting the first two participants in the country onto the COPCOV Covid-19 prophylaxis study, as featured on BBC news today. Here our are research lab staff about to process the first samples for the trial. #COVID #covidresearch pic.twitter.com/2VSfw7cEVp
— BSUH Research (@BSUHresearch) May 21, 2020
A UK-based medicines manufacturer, Accord Healthcare, has already promised to donate over two million tablets of hydroxychloroquine and placebo for this historic trial.
News from MFI member company Accord Healthcare that it is donating 2 million tablets of hydroxychloroquine to largest COVID-19 trial in the world involving 40,000 frontline healthcare workers https://t.co/1QhsKqmBKX @PadraicOBrien @MargueritePearl @medicinesforEU #covid19 #covid
— Medicines for Ireland (@MedicinesForIRL) March 31, 2020
In the statement professor Sir Nicholas White from the University of Oxford explained that the team does not know if these drugs will work. He said “The best way to find out if they are effective in preventing Covid-19 is in a randomized clinical trial. That’s what COPCOV is – and why we’re doing this study”.
Though all of the participating countries are right now setting up to go ahead with the trial, but a drop in the coronavirus cases in these countries for the time being could mean slower ongoing trials for drugs and vaccines, as staff will be less likely to get infected.
The team is expecting additional 4 sites to open by the end of May, and a total 25 UK sites by the end of the June. Results of the trial will come by this year’s end.
These drugs are being used to treat malaria for more than 60 years and are generally considered safe. However, mild side effects can include upset stomach, nausea, headache, blurry vision. A high dose however can be fatal. There is also a concern that these drugs cause prolonged QT interval, which can lead to abnormal heart rhythm.
A new study — the largest of its kind — shows that hydroxychloroquine, the drug touted by US President Trump, does not work against Covid-19 and could cause heart problems https://t.co/ktNcSLkQGM
— CNN International (@cnni) May 19, 2020