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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.
Rise in COPCOV numbers continues; study to end recruitment 30 Nov
2 November 2021
A global study examining the impact of chloroquine / hydroxychloroquine in preventing COVID-19, COPCOV has recruited 3,386 participants as of 26 Oct from sites in Benin, Côte d’Ivoire, Indonesia, Kenya, Mali, Nepal, Pakistan, Zambia, and closed sites in Thailand, Niger and the UK. Last week, the COPCOV team agreed with active site research teams that it will continue to recruit new participants until 30 Nov 2021, with preliminary study results expected Q1 2022.
COPCOV now world’s largest COVID-19 pre-exposure prophylaxis trial
30 July 2021
A 6-week recruitment burst at Aga Khan University in Pakistan led the way as COPCOV enrolment broke 1600 participants. Led by MORU, COPCOV is the world’s largest trial trying to determine if hydroxychloroquine and chloroquine prevent COVID-19.
Recruitment surges in COPCOV COVID-19 prevention study
9 July 2021
As high COVID-19 daily cases and highly transmissible variants risk overwhelming countries’ healthcare systems, COPCOV, the world’s last-standing large prophylaxis RCT, faces tight timelines to determine whether chloroquine/ hydroxychloroquine prevents COVID-19
The COPCOV Trial’s position statement on “A living WHO guideline on drugs to prevent COVID-19.”
5 March 2021
Following WHO recommendations against the use of hydroxychloroquine in the prevention of COVID-19, including its use in controlled trials, we are reviewing the guideline and available evidence. We are concerned that this judgement from the authors of the guideline is scientifically unsound.
Applicability of COVID-19 vaccine trial results to low-and-middle-income countries
5 November 2020
In the next few months, the first Phase 3 COVID-19 vaccine trials – the majority of them in upper-middle or high-income countries and in specific target populations like young adults – will report their results. How relevant will their study results be for low-resource settings?
Hydroxychloroquine doses in COVID-19 prevention trials should be safe, study finds. Now let’s find out if they’re effective.
10 September 2020
As the world waits impatiently for a COVID-19 vaccine, an exhaustive review of hydroxychloroquine and chloroquine pharmacology suggests that the doses used in COVID-19 prevention trials are safe, say University of Oxford affiliated researchers in a study published in PLoS Medicine.
Hydroxychloroquine is being discarded prematurely in COVID-19 prevention
6 August 2020
Hydroxychloroquine could still prevent COVID-19 and save tens of thousands of lives around the world, say leading scientific researchers. While it doesn’t work in treatment of hospitalised patients, it could still prevent infections. However, fraudulent data, unjustified extrapolation and exaggerated safety concerns together with intense politicisation and negative publicity may stop COPCOV, the only large, global clinical trial testing hydroxychloroquine in COVID-19 prevention, from ever finding out.
UK regulator gives green light to clinical trial of hydroxychloroquine to prevent Covid-19 in healthcare workers
30 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.
Major medical journals retract Covid-19 studies
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.
An open letter to Richard Horton, editor of The Lancet regarding Mehra et al
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.
COPCOV study paused
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.
SEBCOV study launched 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.
GroupMappers create real-time COVID-19 Bangladesh dashboard
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.
COPCOV Covid-19 study prepares to begin participant enrolment
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.
Global call for strategic planning for COVID-19 medical products
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.
COVID-19 Therapeutics Accelerator awards $20 million in initial grants to fund clinical trials
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.