Green light for COVID-19 trial recruitment

News story

The MHRA has approved the recruitment of further participants for a clinical trial by the University of Oxford

Medicines

The MHRA has approved the recruitment of further participants for a clinical trial investigating hydroxychloroquine in prevention of COVID-19, by the University of Oxford.

Dr Siu Ping Lam, Director of Licensing at the MHRA, said:

We have reviewed the University of Oxford’s request to recommence recruitment for the ‘COPCOV’ trial, investigating the use of hydroxychloroquine in the prevention of COVID-19.

After analysing the additional risk mitigations and consulting the Commission on Human Medicines, we have given the clinical trial the green light to recruit more participants.

Participant safety is our priority, so we will continue to monitor the trial to ensure ongoing appropriate measures are in place to maintain continued high levels of safety.

The MHRA received a request from the University of Oxford, on 17 June, to recommence recruitment to the ‘COPCOV’ trial investigating hydroxychloroquine in the prevention of COVID-19.

The submitted justifications and supporting information were reviewed by the MHRA, with independent advice obtained from the Commission on Human Medicines. On 26 June it was agreed that sufficient measures had been taken to support the safe recruitment of further participants.

The decision follows the MHRA’s instructions, on 8 June, to UK clinical triallists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of participants until further data, which justifies continuation, have been provided, and any additional safety measures have been implemented.

Published 26 June 2020




Stay safe around rivers: warning as lockdown eased and temperatures soar

As the government eases restrictions on movement caused by the coronavirus outbreak, the public is being warned to keep safe around rivers and canals.

The Environment Agency, which manages many locks, weirs and bridges across England, wants people to remember the hazards under the water in rivers while spending time with friends and family.

The message is clear: vigilance can save lives, and water-related accidents can be avoided by knowing how to stay safe.

Top tips for river safety:

  • Don’t jump or dive in as the depth may vary and there can be unseen hazards
  • Don’t go in near weirs, locks, pipes and sluices. These and some other water features are often linked with strong currents
  • Inland waters can be very cold, no matter how warm the weather. Those going into cold water can get cramp and experience breathing difficulties very quickly

Keep a look out for boat traffic. Boaters, especially on larger vessels, can find it very hard to spot swimmers.

Toby Willison, Executive Director of Operations for the Environment Agency, said:

It’s imperative that as the coronavirus restrictions are eased, the public are wary of the hazards around them when near or on the water.

We urge people not to jump or dive into water and to stay away from weirs, locks and pipes. There can be unseen hazards in the water, cold-water shock can affect even strong swimmers on warm days and social distancing must be continued to protect the public, staff and boaters.

Jo Talbot, Royal Lifesaving Society (RLSS) UK Director, said:

We as a charity are certainly concerned about the impact of such a beautiful spell of weather on the number of people that are involved in fatal water incidents. It is a great time to get out and enjoy our beautiful waterways but it is crucial that everybody understands that no matter their ability, the water comes with risk, in particular the impact of cold water and falling from heights.

Despite the warm air temperature, the water temperature is still dangerously and often fatality cold, it can debilitate the most competent swimmer. Many people simply do not have the experience to swim in cold water and if they aren’t used to it then, simply, our advice is that they should not go in. We are urging people to proceed with caution, take responsibility of their own safety and apply common sense.

The right choices, at the right time results in an enjoyable day around the water. For advice on how to stay safe around the water, visit the RLSS website.

Parents and guardians can help keep children in their care safe by:

  • Teaching them to swim
  • Warning them not to go into water alone, or unsupervised
  • Ensuring they know where the children are and what they are doing
  • Supervising them closely when near any open water

Drowning can occur very quickly, even in shallow water, and the key to keeping safe is to take all necessary precautions to avoid getting into difficulty in the first place.

Unexpectedly cold waters or strong currents can also catch bathers off-guard.

Youngsters are often seen jumping off the many bridges along the Thames. While this may seem like great fun, there are hidden dangers in the water that can cause tragic consequences.

Guidance on staying safe around water can be found on GOV.UK.

Further information




British nationals stranded in Chile returned to the UK

On Thursday 11 June, a UK Government organised charter flight left Santiago for London Heathrow Airport, returning British nationals and residents stranded in Chile. Passengers first took a plane to Quito, Ecuador, where they joined British nationals stranded in Ecuador on a second flight to London.

In total, 64 British nationals and residents, as well as large numbers of foreign nationals in transit, were returned to their homes. In Chile, people travelled from all over the country, including from Easter Island and towns 2,000 km away from Santiago, to take the scheduled flight. Most of these people had been unable to leave Chile for nearly three months. Short-term family winter escapes had suddenly turned into quarter-years hunkered down in a foreign country in the midst of a global pandemic.

A major logistical effort

The Embassy’s Consular team worked tirelessly to provide the prospective passengers with all necessary information, to resolve issues, and to offer unending attention to our most vulnerable British citizens.

The organising of this charter flight required a great all-of-Embassy effort. On the frontline, the Embassy’s Consular team worked tirelessly to provide the prospective passengers with all necessary information, to resolve issues, and to offer unending attention to our most vulnerable British nationals. The Communications team similarly did all it could to respond to queries and to disseminate information widely and inventively. Other members of Embassy staff had to put their day jobs on hold and take up some of the engagement with passengers, answering umpteen questions and easing concerns.

Meanwhile, behind the scenes there was close coordination discussion with the two airlines involved, colleagues in Quito and London, the Chilean Government, the Santiago airport authorities, and the company responsible for managing passenger bookings. A logistics team worked out possible routes for British nationals in other parts of Chile to get to Santiago and tracked their progress, as well as finding hotels open in the capital and operating taxi services. A team of Embassy staff, including the Deputy Head of Mission, was deployed to the airport to support passengers and resolve any issues.

Success at last

Many weary British nationals had travelled from all across Chile to catch the charter flight. After numerous cancelled international flights the UK charter flight gave them the certainty that they could return home.

The hard work of the Embassy team was well worth it, with our 64 British nationals back safely in the UK. The Embassy extends its sincere thanks to the Chilean government and local authorities for their extremely collaborative approach. There are still some British nationals in Chile seeking to return to the UK who could not take this flight and the Embassy is continuing to support these British nationals in their bids to get home.

Regarding the passengers impressions at the Santiago airport, Gareth Taylor, Head of the Economics and Trade Office, said:

I spoke to many weary British nationals who had travelled from all across Chile to catch the charter flight. After numerous cancelled international flights the UK charter flight gave them the certainty that they could return home.

Further information

If you want to know more about the Charter Flight, contact Christopher Hope, Head of the Covid19 Taskforce, British Embassy, Santiago.

For more information about the events and activities of the British Embassy in Santiago, follow us on:




New cross border byelaws to protect salmon and sea trout

The byelaws, some which will be in place until the end of 2029, mirror those introduced earlier this year by Natural Resources Wales (NRW) meaning the fish will be protected throughout the two rivers.

This now means all salmon caught on rod and line on the Dee and Wye must be released alive with minimum injury and delay.

Reducing the taking of salmon is only one part of the Environment Agency and NRW’s larger national programmes to protect salmon stocks. Actions taken by the Environment Agency and its partners that contribute to protecting salmon stocks include removing barriers, improving water quality, implementing better agricultural practices and addressing unsustainable water abstractions.

The Environment Agency and NRW are taking these actions because of the need to protect salmon stocks that have declined to unsustainable population levels in many of our rivers. The decline in the numbers of wild salmon, seen not just in English and Welsh rivers but throughout the North Atlantic, is a major concern and the Environment Agency is determined to protect the future of this important species.

Both the Dee and Wye have continued to see salmon stocks decline even with significant efforts by all interested stakeholders to improve their status. The extent of the decline is such that stocks are now approaching unsustainable population levels. The measures seek to maintain the economic value of salmon rod and line fisheries to the local rural economy while maximising the opportunity for salmon spawning. It is hoped in turn that this will increase the future numbers of returning adult salmon to these rivers.

On the River Dee, sea trout stocks have also declined in recent years and maximum sea trout landing sizes have also been agreed.

The Defra Fisheries Minister, RH Victoria Prentis MP, confirmed the proposed byelaws on 8 June. These byelaws will replicate the ‘Cross-border rivers Dee and Wye in Wales’ byelaws made by NRW and confirmed by Welsh Government which came into force on the 31 January 2020.

In addition, new controls on angling methods such as the use of barbless hooks and restrictions on certain baits will be implemented, in order to improve the survival of released fish so that they can contribute to spawning stocks.

Dee and Wye cross border byelaw: example of changes to salmon fishing lures

Measures have also been confirmed to help protect sea trout in many rivers in Wales – these will also apply to the Dee and Wye, with all rod-caught sea trout over 60cm to be released alive.

On the River Wye the new measures should be considered alongside the extensive catch controls that have been in place since 2012 and due to expire in 2021. NRW and the Environment Agency will be reviewing these measures and will formally consult on any new regulations in due course.

Dave Throup Environment Manager for Herefordshire said:

We’re concerned that the number of returning adult salmon continues to decline despite the current protection measures we have in place across the Dee and Wye. We will work closely with NRW to monitor salmon stocks, with a view to introducing further long term protection byelaws on cross border rivers if required following consultation, in the hope of increasing the numbers of this iconic species.

Every spawning fish matters. Even relatively small numbers of fish are crucial in order to recover stocks in as short a time as possible.

We understand the concerns of fishermen, but only by the use of immediate and robust action, with cooperation from others, can we prevent the collapse of salmon stocks.

Peter Gough, Principal Fisheries Advisor for Natural Resources Wales said:

All of our salmon stocks are in serious trouble and have fallen to historically low levels. We believe that the new byelaws, along with a range of other urgent measures such as tackling agricultural pollution, improving water quality, improving habitats and managing potential threats from predators, are vital for the future of salmon and sea trout in Wales.

Note to editors

  • In 2017, the Environment Agency, working in partnership with NRW, formally consulted upon a suite of byelaw measures designed to improve the level of protection afforded to vulnerable salmon and sea trout stocks on the Rivers Dee and Wye which span both the English and Welsh borders.

  • The measures required 100% catch and release of salmon by rod and line angling as well as implementing angling methods that seek to maximise the survival of any salmon that are caught and released.

  • Natural Resources Wales (NRW) has implemented mandatory catch and release byelaws and method restrictions for the 2020 fishing season on all rivers in Wales including the cross border rivers (Dee and Wye).

  • Fines for breaking fisheries byelaws are unlimited.

  • In addition, new controls on angling methods will improve the survival of released fish so that they can contribute to spawning stocks:

  • no worm fishing

  • fly and spin only

  • shrimp and prawn from 1st -30th September (Dee only)

  • the prohibition on bait fishing for salmon in the Wye remains

Hooks

  • all hooks must be barbless or de-barbed

  • no trebles on spinners. spoons or plugs (singles only 13mm gape)

  • up to 3 singles on a plug

  • flies – small trebles allowed up to 7mm gape (approximately size 8)

  • if larger, singles or doubles may be used

  • Measures have also been introduced to help protect sea trout in many of our rivers in Wales, with all rod-caught sea trout over 60cm to be released alive.

  • More information on the Angling Byelaws (fishing rules for Wales and cross border rivers)

  • Current legislation requires all salmon caught before 16 June by rod and line to be returned

  • Legislation already exists to prohibit the sale of any salmon caught by rod and line

  • Salmon stocks in the Dee and Wye are now classed as “Probably at Risk”

  • Reducing exploitation is one action of the ‘Salmon Five Point Approach’ which has been jointly developed and committed to by a wide range of partners including Government, NRW, Atlantic Salmon Trust, Angling Trust, River Trusts, Wild Trout Trust, Salmon and Trout Conservation Association and the Institute of Fisheries Management.




Stay safe around rivers, warns Environment Agency

The Environment Agency is warning people of the dangers of swimming near or jumping off its locks, weirs, and bridges after police were forced to clear around 300 swimmers and sunbathers from a single site yesterday, amidst soaring temperatures and the easing of lockdown restrictions.

Police issued a dispersal order after hundreds of swimmers flocked to Houghton Lock on the Great River Ouse near Huntingdon.

Those gathering were taking unnecessary risks by not social distancing, and swimming too close to an Environment Agency structure in water that could pose hidden dangers for even the strongest swimmers, such as strong currents, underwater hazards and even algae that could make people ill.

Irven Forbes, Anglian Waterways Manager at the Environment Agency, said:

“We manage a large number of structures like locks and weirs to keep our waterways safe, keep our navigation channels clear, and keep homes protected from flooding.

“Every summer we see people put themselves at risk by ignoring warning signs and swimming where it isn’t safe, and we know this can have serious, even tragic, consequences.

“Please don’t take the chance – follow posted safety warnings and guidance from the authorities. If you don’t, you’re risking your life, and you could face a day in court and a steep fine.”

Increased numbers of people have been noted across many Environment Agency structures and sites – despite warnings year on year of the dangers.

But this year, as the country emerges from lockdown, the behaviour poses additional risks not just to those breaking the rules, but to local residents, and is putting additional pressure on police and EA resources.

Guidance on gov.uk – search ‘staying safe around water’ – shows the message is clear: vigilance can save lives, and water-related accidents can be avoided by knowing how to stay safe.

Top tips for river safety:

  • Don’t jump or dive in as the depth may vary and there can be unseen hazards.
  • Don’t go in near weirs, locks, pipes and sluices. These and some other water features are often linked with strong currents.
  • Inland waters can be very cold, no matter how warm the weather. Those going into cold water can get cramp and experience breathing difficulties very quickly.
  • Keep a look out for boat traffic. Boaters, especially on larger vessels, can find it very hard to spot swimmers.

Parents and guardians can help keep children in their care safe by: * Teaching them to swim * Warning them not to go into water alone, or unsupervised * Ensuring they know where the children are and what they are doing * Supervising them closely when near any open water

Drowning can occur very quickly, even in shallow water, and the key to keeping safe is to take all necessary precautions to avoid getting into difficulty in the first place.

Experience shows it is often young people who get into trouble whilst swimming in open water, which contains hazards, particularly in and around structures such as locks, weirs and bridges.

Unexpectedly cold waters or strong currents can also catch bathers off-guard.

For further details about the dangers of wild swimming, follow guidance from Public Health England, the Royal Society for the Prevention of Accidents, and the Royal National Lifeboats Institute.