Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

The UK regulator MHRA announced on 26 June that it would again permit recruitment to the COPCOV COVID-19 prevention clinical trial. The MHRA decision came 5 weeks after it reacted immediately to the now-discredited paper published in The Lancet suggesting harms with hydroxychloroquine, and paused recruitment of UK participants. But The Lancet paper was based on fabricated data and was swiftly retracted. After this interruption, recruitment around the globe to COPCOV can now resume.

COPCOV_FTM_Day © 2020 MORU. Photographer: Supa-at Asarath.

A global study (COPCOV) to determine if hydroxychloroquine or chloroquine can prevent COVID-19 will resume enrolment of workers in healthcare facilities and other staff in contact with COVID-19 patients, after getting approval to proceed from the UK medicines agency.

The MHRA (Medicines and Healthcare Products Regulatory Agency) announced on 26 June that it would again permit recruitment to the COPCOV COVID-19 prevention clinical trial. The MHRA decision came 5 weeks after it reacted immediately to the now-discredited paper published in The Lancet suggesting harms with hydroxychloroquine, and paused recruitment of UK participants. But the paper was based on fabricated data and was swiftly retracted. After this interruption, recruitment around the globe to COPCOV can now resume.

Led by the University of Oxford’s Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, Thailand, the COPCOV study is a double-blind, randomised, placebo-controlled global trial that aims to enrol 40,000 healthcare workers and other at-risk staff to determine definitively if chloroquine and hydroxychloroquine can prevent COVID-19.

There remains no conclusive proof whether the well-established drugs hydroxychloroquine and chloroquine are effective in preventing COVID-19. To date, most studies have focussed on the use of these drugs to treat – and not prevent – COVID-19.

“The results of the large UK RECOVERY trial suggest that in sick patients hospitalised with COVID-19 the corticosteroid drug dexamethasone saves lives but hydroxychloroquine does not. This suggests that inflammation is the main problem in the late stages of the illness whereas the window of opportunity for anti-viral drugs to work may be earlier in the course of the infection. Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomised controlled trial. With 20% of the world’s population living in countries where these drugs are recommended for prevention, the question whether they can prevent COVID-19 or not remains as pertinent as ever,” said COPCOV Co-Principal Investigator Prof Sir Nicholas White, of the University of Oxford who is based at MORU.

The UK arm of the COPCOV study will resume recruitment at the Brighton and Sussex University Hospitals and at the John Radcliffe Hospital in Oxford this week, with more UK sites expected soon.

“Although rates of COVID are low just now in the UK, healthcare workers are still being affected across the NHS and a second wave of infection this winter is widely expected. In terms of finding an intervention that could protect key workers by this winter, hydroxychloroquine is by far the most realistic prospect. The recent post-exposure prophylaxis study confirmed its safety and indicated that it could be protective if given as pre-exposure prophylaxis. This is what COPCOV will find out,” said COPCOV UK lead Investigator Prof Martin Llewelyn, Brighton and Sussex Medical School, UK.

As confirmed COVID-19 cases exceed 10 million globally and continue to rise, protecting healthcare workers from contracting COVID-19 remains vital for the UK and many other countries in the world.

“There remains no preventative drug therapy, no vaccine and no widely available treatment that is effective before a patient is already very sick. If hydroxychloroquine and chloroquine are to work, they are much more likely to affect the disease the earlier they are given, but we need to know one way or another, and soon,” said COPCOV Co-Principal Investigator Dr William Schilling, of the University of Oxford who is also based at MORU.

The COPCOV UK sites are being managed by the Diabetes Trials Unit, University of Oxford. An additional 20 sites are expected to open by September in the UK. Workers in UK healthcare settings wishing to participate in COPCOV should visit the study website www.copcov.org.

“In the UK, NHS staff and other health care workers will continue to put their own health at risk caring for COVID-19 patients for months to come. Anything that could be done to protect them is worth establishing. Those interested in participating should find out more on the study website where they can register to take part,” said Prof Amanda Adler of the University of Oxford.   

Plans are underway for new COPCOV study sites in Thailand and Southeast Asia, Africa and South America. Results are expected by the end of this year (2020).

To learn more, visit COPCOV

To express interest in setting up a COPCOV site, follow this link.

 

Press enquiries, contact: John Blehojohn@tropmedres.ac; +90.537.567.8460 (Mobile/WhatsApp)

Similar stories

RECOVERY trial finds aspirin does not improve survival for patients hospitalised with COVID-19

The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for patients hospitalised with COVID-19. Patients with COVID-19 are at increased risk of blood clots forming in their blood vessels, particularly in the lungs. Between November 2020 and March 2021, the RECOVERY trial included nearly 15,000 patients hospitalised with COVID-19 in an assessment of the effects of aspirin, which is widely used to reduce blood clotting in other diseases. There was no significant difference in the primary endpoint of 28-day mortality

The COVID-19 International Modelling Consortium (CoMo Consortium) enters a new phase

Created in March 2020 to assist policymakers to make use of existing evidence in mathematical and epidemiological models to inform strategies for minimising the impact of COVID-19, the CoMo Consortium brings together mathematical modellers, epidemiologists, health economists and public health experts from more than 40 countries across Africa, Asia and South and North America.

ASM Editor in conversation with Nick White

Malaria continues to be a major killer, particularly in sub-Saharan Africa, affecting the world’s most vulnerable populations with more than 500,000 deaths per year, most of them African children. Emergence of resistance to antimalarial drugs is major public health issue. American Society for Microbiology Editor Dr Cesar Arias discusses with Professor Sir Nick White the latest information on this rapidly evolving field.

New Pandemic Sciences Centre at the University of Oxford

The University of Oxford announces the launch of a centre of global research collaboration and excellence, the Pandemic Sciences Centre. The need for partnership between academic excellence, industry and public health organisations is one of the key lessons learned from the coronavirus pandemic. This centre will unite disciplines, and sectors, to build agile, equitable partnerships that can tackle complex problems and respond to pandemic threats at any time.

AMR and scrub typhus among Chiangrai Unit's research priorities

Which infections are most common in the Chiangrai region? How should we treat them and how can we improve diagnostic? Which strategies are most effective in directing antibiotic treatment? Blog by Carlo Perrone, research physician based at the Chiang Rai Clinical Research Unit in Chiangrai, Thailand.

Arjen Dondorp, Peter Horby and Rose McGready elected Academy of Medical Sciences Fellows

"Although it is hard to look beyond the pandemic right now," says President of the Academy of Medical Sciences Professor Dame Anne Johnson, "I want to stress how important it is that the Academy Fellowship represents the widest diversity of biomedical and health sciences. The greatest health advances rely on the findings of many types of research, and on multidisciplinary teams and cross-sector and global collaboration."