UK regulator gives green light to clinical trial of hydroxychloroquine to prevent Covid-19 in healthcare workers
29 June 2020
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.
COVID-19 prevention and treatment: a critical analysis of chloroquine and hydroxychloroquine clinical pharmacology
20 June 2020
Paper by NJ White et al, PLoS Medicine, in press. Using available pharmacokinetic information from healthy volunteers, the treatment of malaria, the chronic treatment of rheumatological conditions and the toxicokinetics of chloroquine in self-poisoning, the authors predict exposures and safety margins in the high dose chloroquine and hydroxychloroquine COVID-19 prevention and treatment regimens currently under evaluation. These regimens are predicted to have reasonable safety margins. Large, well conducted randomised clinical trials with appropriate monitoring are required to determine if chloroquine and hydroxychloroquine have preventive or treatment efficacy in COVID-19 and acceptable safety. Current recommendations for their use outside of clinical trials are not justified at this time.
9 June 2020
On 4 June 2020, after a week of increasing scientific concern and scrutiny, first The Lancet, then the New England Journal of Medicine, retracted studies that were based on inaccessible data. The studies have been extremely damaging to chloroquine and hydroxychloroquine COVID-19 clinical trials around the globe. MORU researchers played a key role in bringing this scandal to light, whose consequences continue to play out.
Clinical trials on hydroxychloroquine/ chloroquine in COVID-19. Statement in response to damaging recent events
5 June 2020
On 4 June 2020, after a week of increasing scientific concern and scrutiny, first The Lancet, then a little over an hour later the New England Journal of Medicine, retracted studies that were based on inaccessible data, provided by the Surgisphere corporation. The studies have been extremely damaging to chloroquine and hydroxychloroquine COVID-19 clinical trials around the globe. Here is MORU’s statement in response to these events.
29 May 2020
The results of Mehra et al in The Lancet have had a considerable impact on public health practice and research, halted trials and caused considerable concern to participants and patients enrolled in randomised controlled trials (RCTs). This has led many researchers around the world to scrutinise in detail the publication and outline their concerns in this letter to Richard Horton, editor of The Lancet.
26 May 2020
We received notice from the UK's MHRA (Medicines and Healthcare Products Regulatory Agency) to pause for now new enrolment into our COPCOV study. We responded promptly to the MHRA, addressing their concerns in detail and await their decision. For now, COPCOV study enrolment is paused around the globe. The safety of our participants is our first priority, as is preventing illness in front-line healthcare workers.
Global clinical trial of 40,000+ healthcare workers begins to test in UK if chloroquine and hydroxychloroquine can prevent COVID-19
21 May 2020
A global study to test if either chloroquine or hydroxychloroquine can prevent COVID-19 in vital frontline healthcare workers will open to UK participants at hospital sites in Brighton and Oxford today.
1 May 2020
The SEBCOV study aims to produce evidence to inform public health measures such as communications, quarantine, self-isolation, social distancing, and travel restrictions for the COVID-19 pandemic. This study is run in four countries: UK, Thailand, Italy and Malaysia.
24 April 2020
The impact of COVID-19 is quite evident at present – entire countries and cities are under lockdown, offices and industries shut and academia at a standstill. However, many people in Bangladesh remain unaware or indifferent to the warnings and safety protocols that ought to be followed to stop COVID-19’s spread. Since enforcing social distancing in a densely populated country like Bangladesh is very challenging, making people aware and maintenance of hygiene are the main means to stop the spread of COVID-19.
23 April 2020
Less than a month after it was announced, the MORU-led COPCOV study has made quick progress and expects to begin enrolling participants by the end of April.
10 April 2020
Global health experts have united in a call for governments and international organisations around the world to plan strategically for the coordinated production, equitable distribution and surveillance of COVID-19 medical products to ensure access to quality-assured medications for everyone.
BBC World News interviews Nick White on chloroquine and hydroxychloroquine for COVID-19: “These drugs are not harmless, they’re dangerous in over-dose.”
6 April 2020
There are currently no proven vaccines or drugs to prevent COVID-19. In this BBC World News interview, MORU’s Prof Sir Nick White explains why the only way to find out if chloroquine and hydroxychloriquine work against COVID-19 is via randomised, clinical trials and how the hype over chloroquine negatively affects people with lupus and rheumatoid arthritis.
30 March 2020
Researchers at MORU and two institutions in the US (University of Washington and La Jolla Institute for Immunology) receive grants from the COVID-19 Therapeutics Accelerator, a large-scale initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed the development of and access to therapies for COVID-19.