trial

medicine

Stanford Medicine begins enrolling for COVID-19 vaccine trial | News Center

Stanford Medicine has joined a large, Phase 3 clinical trial of an experimental vaccine against COVID-19.

The trial will test whether the vaccine, which is produced by the Janssen Pharmaceutical Companies of Johnson & Johnson, protects people from the disease. It will enroll some 60,000 people at about 180 sites around the world. The Stanford site is expected to enroll about 1,000 participants.  

Participants will receive either the vaccine or a placebo, and their health and immune responses will be monitored for about one year after their initial visits. If any participants become ill with symptoms of COVID-19, a health care provider will go to their homes to assess their health and collect a nasal sample to test for the presence of the novel coronavirus. If they are infected, Stanford physicians will monitor their disease progression. 

“We’re enrolling a wide variety of participants, but we are particularly interested in those who feel like their home or workplace exposure puts them at risk,” said Philip Grant, MD, assistant professor of medicine and the trial’s principal investigator at Stanford. “Teachers, grocery store workers, people who live in multigenerational households, health care workers and students on campus would all be good candidates for participation.”

Participants will be followed for two years and one month. They are expected to visit the trial site eight times: six in the first year and two in the second year. The initial visit will last about two hours; subsequent visits will consist of a short blood draw and symptom screening. If a participant develops COVID-19 during the study period, additional visits may be required.

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fitness

Builder, 45, dies in prison days before facing trial for murdering fitness trainer girlfriend

Builder, 45, dies in prison days before facing trial for murdering his ‘beautiful and kind’ ex-army fitness trainer girlfriend, 26

  • Terence Papworth was charged with murder of Amy-Leanne Stringfellow in June
  • The mother-of-one was found critically injured at his flat in Doncaster on June 5
  • Papworth, 45, a builder, was due to face trial over Amy’s death on November 30 
  • He was found dead in his cell at Armley Prison in Leeds on Sunday, November 22 

A builder has died in prison days before he was due stand trial for the alleged murder of his ‘beautiful and kind’ girlfriend.

Terence Papworth, 45, was charged with the murder of mother-of-one Amy-Leanne Stringfellow, 26, in June.

Ms Stringfellow, who served in Afghanistan, was found critically injured in Papworth’s home in Balby, Doncaster, South Yorkshire, on June 5 this year.

Emergency services battled to save the fitness trainer, but she was declared dead at the scene.

Papworth was charged with her murder two days later and was due to stand trial next week.

However, he was found dead in his cell at Armley Prison, in Leeds, West Yorkshire, on Sunday.

Terence Papworth, 45, was charged with the murder of mum-of-one Amy-Leanne Stringfellow, 26, in June and was due to stand trial later this month

He was found dead in his cell at Armley Prison, in Leeds, West Yorkshire, on Sunday ahead of the trial, following Amy's (pictured) death

Terence Papworth (pictured left), 45, was charged with the murder of mum-of-one Amy-Leanne Stringfellow (pictured right), 26, in June and was due to stand trial later this month. He was found dead in his cell at Armley Prison, in Leeds, West Yorkshire, on Sunday

Papworth was found dead in his cell at Armley Prison (pictured), in Leeds, West Yorkshire, on Sunday

Papworth was found dead in his cell at Armley Prison (pictured), in Leeds, West Yorkshire, on Sunday

Papworth had recently appeared in court via video link for a case management hearing and was due to stand trial on November 30 at Sheffield Crown Court.

The Ministry of Justice said: ‘Terence Papworth died in HMP Leeds on 22 November.

‘The Prisons and Probation Ombudsman has been informed.’

Papworth and Ms Stringfellow, who has a young daughter, had been in a relationship since last October but they had not moved in together.

She had travelled the four miles from her home in Doncaster to see Papworth during lockdown.

After her death, South Yorkshire Police referred itself to the Independent Office for Police Conduct (IOPC) over prior contact they had with Ms Stringfellow.

Private Stringfellow enlisted in the Army in 2010 and completed assignments with 3rd Battalion the Rifles 3 RIFLES in Edinburgh and Chilwell.

She also served a tour of duty in Afghanistan in 2012 as part of the Operation Herrick 16 deployment.

Amy-Leanne Stringfellow, 26, was found critically injured at a house in Doncaster in June. She died a short while later, despite efforts to save her

Amy-Leanne Stringfellow, 26, was found critically injured at a house in Doncaster in June. She died a short while later, despite efforts to save her

Papworth was charged with murder and appeared at Doncaster Magistrates' Court in June. He was due to stand trial on November 30

Papworth was charged with murder and appeared at Doncaster Magistrates’ Court in June. He was due to stand trial on November 30

Amy had been promoted to Lance Corporal but was discharged before taking up the post.

The fitness fanatic rejoined as a Volunteer Reservist in 2017 and also worked as a personal trainer.

Tributes

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medicine

Biohaven Pharmaceuticals And Weill Cornell Medicine Collaborate To Initiate Proof Of Concept Trial With CGRP Receptor Antagonist In Plaque Psoriasis

NEW HAVEN, Conn., Nov. 16, 2020 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates, today announced that Dr. Richard Granstein, M.D., Chairman of Dermatology at Weill Cornell Medicine in New York City, will initiate an investigator-led clinical trial with a Biohaven CGRP-receptor antagonist for the treatment of plaque psoriasis.

Vlad Coric M.D., Chief Executive Officer of Biohaven commented, “Biohaven’s neuroinnovation portfolio is powered by a combination of strong science and patient need. Dr. Granstein is a foremost expert in the CGRP-related biology of dermatological conditions, which has been a focus of his research for nearly two decades. We are committed to following the science of CGRP-receptor antagonism across disease states and Dr. Granstein’s pioneering work affirms that neuropeptide CGRP may play a critical role in plaque psoriasis.  This scientific foundation, together with a recognized need for more safe and effective treatment options for people suffering with psoriasis, has inspired our meaningful collaboration.”

The investigator-led clinical trial will explore whether treatment with one of Biohaven’s CGRP-receptor antagonists will reduce the severity of disease and percentage of area affected as measured by patients’ Psoriasis Activity Severity Index (PASI) score after 16 weeks of treatment as compared to placebo. In addition, the study will assess the potential impact on itch and patient quality-of-life measures.

Dr. Granstein commented, “The animal models and clinical reports of CGRP in psoriasis suggest that CGRP receptor antagonism could alleviate the severity of disease. This clinical study will enable us to evaluate this therapeutic candidate’s efficacy, the findings of which will be the first step in bringing this novel, translational idea to patients. Pathways by which the nervous system exerts regulatory effects on immunity may prove to provide important druggable targets for a range of inflammatory disorders.”

Biohaven’s CGRP-receptor antagonist platform includes Nurtec™ ODT (rimegepant) and zavegepant. Nurtec ODT™ was approved by the FDA in February 2020 for the acute treatment of migraine. Biohaven filed a supplemental New Drug Application (sNDA) for Nurtec™ ODT (rimegepant) for the preventive treatment of migraine earlier this year which was accepted for review in October 2020. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.

Zavegepant is a third generation, high affinity, selective and unique, small molecule CGRP receptor antagonist that is structurally distinct from rimegepant. Zavegepant may be suitable for multiple routes of delivery including nasal, subcutaneous, inhalation or oral administration. Positive results were announced in late 2019 from a Phase 2/3 study of intranasal zavegepant in the acute treatment of migraine, and the company plans to initiate an additional Phase 3 study before the end of 2020. Biohaven also initiated a Phase 2 trial with intranasal zavegepant in April 2020 in collaboration with Thomas Jefferson University in Philadelphia, PA, to study the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response in pulmonary function which in

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medicine

Rocket Pharmaceuticals Receives Funding from the California Institute for Regenerative Medicine for Phase 1 Clinical Trial of RP-L401 for Infantile Malignant Osteopetrosis

NEW YORK–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the California Institute for Regenerative Medicine (CIRM) has awarded Rocket a $3.7 million CLIN2 grant award to support the clinical development of its lentiviral vector (LVV)-based gene therapy, RP-L401, for the treatment of Infantile Malignant Osteopetrosis (IMO), a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure. The CIRM was founded in 2004 following the passing of Proposition 71 or the California Stem Cell Research and Cures Initiative, which allowed $3 billion in state funding for stem cell research conducted in California. This will be Rocket’s second CIRM grant after receiving one in 2019 for the development of the company’s gene therapy for Leukocyte Adhesion Deficiency-I (LAD-I).

“We’re grateful the CIRM has recognized the promise of RP-L401 for IMO, a devastating pediatric rare disease for which the primary treatment option is allogeneic bone marrow transplant,” said Jonathan Schwartz, M.D. Chief Medical Officer and Senior Vice President of Rocket. “RP-L401 could be a potentially curative treatment for this devastating disorder that affects children at a young age, and we are thankful to have this meaningful support from the CIRM to move our program forward for these families.”

Rocket’s Investigational New Drug Application (IND) for RP-L401 was accepted by the U.S. Food and Drug Administration (FDA) in June of 2020, and the gene therapy received Fast Track designation from the FDA in August 2020. Proceeds from the grant will help fund clinical trial costs, as well as provide manufactured drug product for Phase 1 patients enrolled at the U.S. clinical trial site, University of California, Los Angeles, led by principal investigator Donald B. Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), Molecular and Medical Pharmacology, and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los Angeles. The non-randomized, open-label Phase 1 clinical trial will enroll two pediatric patients, one month of age or older. The trial is designed to assess safety and tolerability of RP-L401, as well as preliminary efficacy, including potential improvements in bone abnormalities/density, hematologic status and endocrine abnormalities. Further information about the clinical program is available here.

About Infantile Malignant Osteopetrosis

Infantile Malignant Osteopetrosis (IMO) is a rare, severe autosomal recessive disorder caused by mutations in the TCIRG1 gene, which is critical for the process of bone resorption. Mutations in TCIRG1 interfere with the function of osteoclasts, cells which are essential for normal bone remodeling and growth, leading to skeletal malformations, including fractures and cranial deformities which cause neurologic abnormalities including vision and hearing loss. Patients often have endocrine abnormalities and progressive, frequently fatal bone marrow failure. As a result, death is common within the first decade of life. IMO has an estimated incidence of 1 in 200,000. The only treatment option currently available for IMO is an

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medicine

The Lancet Respiratory Medicine: Clinical trial finds inhaled immune response protein increases odds of recovery for hospitalised COVID-19 patients

Peer-reviewed / Randomised Controlled Trial / People

  • Inhaled delivery of a formulation of a key protein involved in the immune response – interferon beta-1a – to hospitalised COVID-19 patients in the UK reduced the odds that they would develop severe disease or die from SARS CoV-2 infection.
  • Those patients who received inhaled interferon beta-1a were more than twice as likely to recover from COVID-19 infection to a point where everyday activities were not limited compared with those who received a placebo.
  • The trial included 101 patients, with the data providing strong rationale for larger studies to further investigate the impact of this treatment on clinical outcomes.

Hospitalised COVID-19 patients in the UK who received an inhaled form of interferon beta-1a (SNG001) were more likely to recover and less likely to develop severe symptoms than patients who received a placebo, according to a new clinical trial published in The Lancet Respiratory Medicine journal. This is the first evidence published in a peer-reviewed medical journal that inhaled interferon beta-1a could lessen the clinical consequences of COVID-19 and serves as proof-of-concept that this treatment could help hospitalised patients recover, but further research is required.

As the number of COVID-19 infections continues to rise around the world, there is a pressing need to develop new treatments for the more severe and life-threatening symptoms such as pneumonia and respiratory failure.

Interferon beta is a naturally occurring protein that coordinates the body’s immune response to viral infections. Laboratory studies have found that the SARS CoV-2 virus directly suppresses the release of interferon beta, while clinical trials demonstrate decreased activity of this important protein in COVID-19 patients. The formulation of interferon beta used in this new study – SNG001 – is directly delivered to the lungs via inhalation and has been trialled in the treatment of asthma and chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the safety and efficacy of SNG001 to treat hospitalised COVID-19 patients.

The trial was conducted at nine UK hospitals with patients who had a confirmed SARS-CoV-2 infection. It compared the effects of SNG001 and placebo given to patients once daily for up to 14 days, and followed up patients for a maximum of 28 days after starting the treatment. Patients were recruited from March 30 to May 30, 2020, and were randomly assigned to receive the treatment or a placebo. All members of the research team were blinded to which group the patients were allocated. During the study, changes in the clinical condition of patients were monitored.

Of the 101 patients enrolled in the study, 98 patients were given the treatment in the trial (three patients withdrew from the trial) – 48 received SNG001 and 50 received a placebo. At the outset of the trial 66 (67%) patients required oxygen supplementation at baseline (29 people in the placebo group and 37 in the SNG001 group). Patients who received SNG001 were twice as likely to show an improvement in their clinical condition at day 15 or 16, compared with

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medicine

Greenwich LifeSciences, Inc. Announces Partnership with Baylor College of Medicine for its Planned Phase III Clinical Trial

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the formation of a partnership with Baylor College of Medicine in Houston, Texas to act as the lead clinical site for the Company’s upcoming Phase III clinical trial. Professor Mothaffar F. Rimawi has agreed to serve as the Global Principal Investigator of the Phase III clinical trial, and Professor C. Kent Osborne and Professor Rimawi are expected to serve as the first members of the Company’s Clinical Advisory Board for the development of GP2 immunotherapy across all indications and HER2 expressing cancers.

Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are pleased to have entered into this collaboration with such prominent key opinion leaders who are truly committed to evaluating the potential of GP2 immunotherapy. Due to GP2’s safety profile, GP2 immunotherapy may provide clinicians with an option to deescalate treatment of patients by reducing the use of other, more toxic and expensive standard of care treatments. Both Professors Rimawi and Osborne have already introduced us to other breast cancer clinical sites and clinical leaders who have provided input into the design of the upcoming Phase III trial and who have expressed an interest in participating in the Phase III trial as high enrollment sites. In addition, we have also been jointly exploring the addition of both US and European breast cancer cooperative groups to more rapidly expand the clinical team.”

Professor Rimawi added, “We are excited to jointly evaluate the potential of GP2 immunotherapy. We believe that our patients will seek to participate in the upcoming trial as the GP2 Phase IIb clinical trial data suggests that GP2 could be both safe and effective and could be easily administered during standard of care follow-up visits. Our patients are seeking safe preventative treatments that allow them to transition away from the trauma of surgery, trastuzumab-based therapies, other HER2 targeted therapies, chemotherapy, and radiation as they seek to return to normal and healthy lives.”

Professor Osborne commented, “Bringing new alternatives to chemotherapy and improving quality of life for patients undergoing treatment for breast cancer are primary focuses of the Breast Cancer Program. GP2 immunotherapy may represent one such opportunity, and we look forward to collaborating with Greenwich LifeSciences and supporting the planned clinical trial with the resources of both the Dan L Duncan Comprehensive Cancer Center and the Baylor College of Medicine.”

Professor Mothaffar F. Rimawi is board certified in internal medicine, hematology and medical oncology, and serves as both Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center.

Professor C. Kent Osborne is board certified in internal medicine, hematology and medical oncology, and serves as both the Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center. Professor Osborne is also Professor of Medicine and Molecular and

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medicine

I was part of a trial for Pfizer’s covid-19 vaccine. It’s a miracle for genetic medicine.

Walter Isaacson, a professor at Tulane, is the author of “The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race,” to be published in March.

“Look me in the eyes,” the doctor ordered, staring at me from behind her plastic face guard. Her eyes were blue, almost as blue as her hospital mask. Yet, after a moment, I started to turn and face the doctor on my left, who was jabbing a long needle deep into the muscle of my upper arm. “No!” the first doctor snapped. “Look at me!”

Then she explained. Because I was part of a double-blind clinical trial of an experimental covid-19 vaccine, they had to make sure that I didn’t get any clues about whether I was being injected with a real dose or merely a placebo made of saline solution.

It was early August, and I had enlisted in the clinical trial for the vaccine that has just reported very promising results: the one developed by Pfizer with the German company BioNTech. It is a new type of RNA vaccine that has never before been deployed.

Vaccines work by stimulating a person’s immune system. One traditional approach is to inject a weakened version of the dangerous virus. That’s the way we now fend off measles, mumps, rubella and chickenpox. Another method is to use a version of the virus or a part of the virus that has been totally killed.

The success of the Pfizer vaccine means that the plague year of 2020 will be remembered as the time when traditional vaccines began to be supplanted by genetic vaccines. Instead of delivering tiny and safe doses of the virus itself, these new vaccines deliver a piece of genetic coding that will instruct human cells to produce, on their own, components of a targeted virus. These safe components can then stimulate the patient’s immune system.

[Full coverage of the coronavirus pandemic]

It is another wondrous miracle from a biotech revolution in which knowledge of genetic coding will become as important as digital coding and molecules will become the new microchips.

I enrolled in the trial at Ochsner Hospital in my hometown of New Orleans partly to be a good citizen but also because I’m writing a book about the gene-editing tool known as CRISPR, and the star molecule in the book is RNA. The vaccine that was developed by Pfizer and BioNTech makes use of the most basic functions that RNA performs: serving as a messenger RNA (mRNA) that carries genetic instructions from DNA, which is bunkered inside a cell’s nucleus, to the manufacturing region of the cell, where it directs what protein to make. In the case of the covid-19 vaccine, the mRNA instructs cells to make a version of the spike protein that is on the surface of a coronavirus. That spike protein can then stimulate our immune system to create antibodies that will protect against the real coronavirus. In addition to the Pfizer version, the

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health

China’s Fosun to end BioNTech’s COVID-19 vaccine trial, seek approval for another

SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.

Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.

The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States shortly after enough safety data is provided as early as this month.

But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.

Hui said he did not regret testing BNT162b1 without waiting for more complete data. “For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?” Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.

A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.

Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.

(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim and Stephen Coates)

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health

Soleno Therapeutics Announces Presentation of Body Composition Results from DESTINY PWS, a Phase III Trial of DCCR in Prader-Willi Syndrome

REDWOOD CITY, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced presentation of body composition data from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS). The results were presented today by Parisa Salehi, M.D., Clinical Director of the Prader-Willi Syndrome Clinic at Seattle Children’s Hospital, in a late-breaking oral presentation at The Obesity Society’s ObesityWeek® 2020 meeting. Dr. Salehi presented the data on behalf of the DESTINY PWS Investigators.

DESTINY PWS is a randomized, double-blind, placebo-controlled Phase III study of once daily oral administration of DCCR in 127 PWS patients conducted at 29 sites in the U.S. and U.K. The objective of the study was to assess the efficacy and safety of DCCR in subjects with genetically-confirmed PWS aged four years and older and weighing between 20 and 134 kg. Patients who completed the double-blind study enrolled in study C602, an ongoing open-label, extension study. Updated top-line results were previously announced in September 2020 that demonstrated DCCR’s beneficial impact on hyperphagia, the predominant symptom of PWS, other behaviors and body composition abnormalities typical of PWS.

Key results for effects on body composition and adipokines following DCCR treatment were presented at ObesityWeek 2020 as follows:

Fat mass and body mass:

  • Significant reductions in fat mass (p=0.0027) were observed after 13 weeks of double-blind treatment
    –  Greater mean reductions in fat mass were observed in those participants weighing more than 100 kg at baseline (placebo-adjusted difference -4.82 kg)

  • Linear exposure-response relationship for fat mass was significant with greater fat loss occurring at higher circulating drug concentrations (p<0.0001)

  • Trend towards increased lean body mass for DCCR compared to placebo (p=0.058)

  • Significant increase in lean body mass/fat mass ratio (p=0.001)

Leptin:

  • Significant reduction in leptin while it increased in placebo-treated subjects (p<0.0001)

  • Linear exposure-response relationship for leptin was significant with greater reductions in leptin occurring at higher circulating drug concentrations (p<0.0001)

  • Reductions in leptin were greater than would be predicted solely by the loss of body fat, suggesting an improvement in leptin sensitivity

Adiponectin:

  • Adiponectin, a cardioprotective hormone, increased in DCCR-treated subjects, but decreased in placebo-treated participants (p<0.0001)

“We are pleased to present further results from the DESTINY PWS study that demonstrate DCCR’s effect on body composition. In the DCCR group compared to placebo, we have observed a significant reduction in fat mass and leptin. Improvements in leptin sensitivity, as suggested by the results, may have an important impact on regulating hyperphagia,” said Dr. Salehi. “The data presented to date show that DCCR has the potential to manage both behavioral and co-morbid metabolic components of PWS.”

“These data represent additional means by which DCCR may address the significant unmet medical needs and the life-threatening comorbidities associated with PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We remain focused on advancing DCCR as a potential treatment

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health

Britain to trial citywide testing in Liverpool

LONDON — The British government plans to trial a new citywide coronavirus testing program in Liverpool, offering regular testing to everyone who lives and works in the city of 500,000 in an effort to slow the spread of the virus.

Testing will take place throughout the city using a variety of technologies, including new methods that can provide results in an hour or less.

The Department of Health says, “these more advanced tests will help identify infectious individuals who are not displaying symptoms … so they can self-isolate and prevent the virus from spreading.”

The Liverpool trial is seen as a test of how Britain might be able to roll out mass testing across the country, which is battling a surge in coronavirus infections. England is scheduled to begin a second national lockdown on Thursday.

Liverpool has one of the highest infection rates in England, with more than 410 cases per 100,000 people.


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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Huge voter turnout expected in U.S. despite virus, political rancor

— ‘Raw exposed nerves’: Anxious nation awaits Election Day

— U.S. hospitals are scrambling to hire more nurses as the coronavirus pandemic surges, leading to stiff competition and increased costs

— Widely shared photo of Biden without mask was taken in 2019

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— Follow AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

COLOMBO, Sri Lanka — Authorities in Sri Lanka have extended the school holidays for two more weeks, postponing the opening of classes amid a surge of COVID-19 patients from two clusters in Colombo and the capital’s suburbs.

Schools had been scheduled to reopen Nov. 9, but the government announced Tuesday that classes would not resume until Nov. 23.

Schools were suddenly closed last month as a precautionary measure after a new cluster of coronavirus infections centered on a garment factory erupted in the densely populated Western province, where the capital is. Another cluster centered on the country’s main fish market arose later.

The two clusters have now grown to 7,856 confirmed cases, with 275 in the previous 24 hours. The total caseload for the pandemic stands at 11,335 with 21 deaths from COVID-19.

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NEW DELHI, India — India has registered 38,310 confirmed coronavirus cases in the last 24 hours, maintaining an overall downturn even as fresh infections continue to appear in its capital, New Delhi.

The Health Ministry on Tuesday also reported 490 more fatalities from COVID-19, raising the overall death toll to 1,23,097.

With a total of 8.2 million coronavirus cases during the pandemic, India is the second worst-hit country behind the United States. But it has been witnessing a steady fall in daily cases.

Still, health officials say New Delhi remains in the grip of its third and worst wave of infections yet. In the past week, there were more than 5,200 cases on average every day. The Health Ministry attributes the city’s surge to the festival season, with people crowding markets for

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