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Amid the coronavirus pandemic, Healthy.io has launched a smartphone-based diagnostic for urinary tract infections available to women at home, without a trip to the doctor or pharmacist.

The new service comes amid concerns that some people are deciding to stay away from healthcare services during the COVID-19 crisis, either to avoid adding to the stress on the NHS or for fear of being exposed to the coronavirus.

Healthy.io launched its first Dip.io UTI test kit in the UK through Boots and Day Lewis Pharmacies last year, but now says women can use the new Velieve service to get “a test, diagnosis and antibiotic treatment without leaving the house.”

The company also says it is “significantly subsidising” the service of the next 60 days as the COVID-19 lockdown continues, reducing the cost to the patient to £10.

UTIs – also known as cystitis – are one of the most common types of infection dealt with by GPs, accounting for an estimated 3% of all visits. In England alone, that adds up to around 10 million consultations a year.

A Public Health Survey suggested recently that 95% of women with UTI symptoms visit a doctor and 74% take antibiotics to resolve them.

Healthy.io’s Velieve test combines the traditional dipstick test used by GPs and a pop-up cup to collect a urine sample with a coloured panel that can be used to get a diagnosis using a dedicated smartphone app. It is carried out with guidance from Emily, an in-app nurse who facilitates the test step-by-step.

To make it suitable for use at home, the company has now partnered with online clinician firm Medicspot to launch a new service that does away with a face-to-face healthcare consultation, which it says is a first for the UK market.

The urine testing kit can be ordered and delivered to a home within hours, and after testing an online clinician will diagnose whether the patient has a UTI.

If the result is positive, antibiotic treatment can be ordered for another £15 and delivered by courier to their door “within…three hours”, according to Healthy.io.

That is only the case however for patients living within its initial roll-out area in central London, although the company says it plans to expand the service to the Greater London area in the coming weeks.

“Traditionally, women suffering from a UTI need to secure a GP appointment for treatment and if they are prescribed antibiotics, they need to pick the medication up from a pharmacist,” according to the Israeli start-up.

“Now, women suffering from the painful condition no longer need to leave their homes and risk exposure to COVID-19 for diagnosis and treatment.”

The Velieve test is the only home urinalysis kit with US and EU approval, it says.

The first doses of Gilead’s COVID-19 drug remdesivir are set to arrive in US hospitals this week after the FDA said the medicine can be used to fight the coronavirus pandemic. 

Although remdesivir is yet to be formally reviewed by the FDA, the regulator said that top-line results from phase 3 trials were compelling enough to grant an Emergency Use Authorization (EUA) to fight the COVID-19 pandemic. 

The FDA referred to the phase 3 data published by the US National Institute for Allergy and Infectious Disease (NIAID) last week showing that remdesivir helps reduce recovery time in patients hospitalised with serious COVID-19 symptoms. 

Median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo, and there was a non-significant trend suggesting a survival benefit. 

The FDA also referred to data from Gilead’s phase 3 trial showing that a five-day treatment regimen produced similar effects to a 10-day treatment regimen in seriously ill patients – an important development as it increases the number of patients who could receive the drug. 

Under the EUA the US government will be in charge of distributing remdesivir to hospitals and clinics across the country. 

Gilead has donated its entire supply of 1.5 million vials of the injected drug to the US government. 

Gilead’s CEO Daniel O’Day told CBS News’ Face The Nation programme: “We are now firmly focused on getting this medicine to the most urgent patients around the country here in the United States.  

“We intend to get that to patients in the early part of this next week, beginning to work with the government, which will determine which cities are most vulnerable and where the patients are that need this medicine.”

Former FDA commissioner Scott Gottlieb, who also appeared on the show, added: “Remdesivir is an effective drug. It’s going to help some patients, especially when used early in the course of disease, to reduce hospitalisations, and reduce death.” 

Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor, which works by interfering with the action of an enzyme involved with viral reproduction. 

Digital health firm Withings has used its technology to produce a read-out of how COVID-19 lockdowns have affected the health of its users, showing a smaller than expected increase in weight, a global yoga craze and an increase in exercise in some areas of the US.

Overall results showed that while the changes to routine had caused some people to gain weight and cut back on exercise, the effects of isolation were not as drastic as some people feared. 

Results from the survey showed that in the US only 37% of people have gained more than a pound, with the average gain at only .21 pounds (0.95 kgs).

Other countries have seen similar weight gain trends of people gaining around half a pound or less during isolation. 

In the UK the figure was .16 kgs, in Germany the average person gained .189 kgs, in China the figure was .25 kgs, and in Italy the average gain was .195 kgs. 

In France, the lockdown has had the smallest impact on weight, where the average person has only gained .084 kgs. 

Withings said that research has not revealed why this has happened – but it suggested that home-cooked meals are healthier because they cause people to eat more nutritious foods and take in fewer calories. 

Results also showed that in the US people have only decreased their daily steps by an average of 7% during isolation, compared with 12% globally. 

But findings varied from state to state, with New York seeing the largest decrease in daily steps of 22%, where lockdown restrictions are the toughest. 

In some states, the number of steps actually increased, up by 16% in Indiana, and by 11% in Connecticut. In Ohio and Michigan the number of steps increased by 6% and Louisiana also saw the number of steps increase by 4%.

In the UK the steps taken were down by 8%, and the tough lockdown in China had the biggest impact with steps decreasing by over half (56%) in Hubei, where the pandemic first originated. 

There has also been a global surge in yoga, which saw a 42% increase in popularity, hiking (up 34%), indoor cycling (a 19% increase) and running (an 18% increase). 

Sleep patterns have been disturbed, however, with those in America going to bed 11 minutes later than usual and waking up almost 26 minutes later than usual. 

The country that gained the least weight also got the most sleep, where people had an average 20 minutes and 40 seconds more sleep each night. 

This reinforced findings by Withings’ predecessor Nokia that people who sleep less are more likely to be overweight or obese.

President Trump’s Operation Warp Speed has a goal of making 100 million doses of a vaccine against COVID-19 available by November, 200 million by December and 300 million by January 2021. Operation Warp Speed has reduced a possible 93 vaccine programs to 14 top candidates, which they expect will be further narrowed to six or eight.

The Hill reports that the six or eight selected will go into clinical trials, where “health experts are looking to weed out faulty candidates and come out with three or four vaccines that clear final testing to be used by early 2021.”

“Can I say with 100% certainty? No,” said one of the officials. “There is a reasonable probability that one or more of these vaccines will be successful.”

President Trump had indicated he will be overseeing the program himself. However, at the agency level, Alex Azar, secretary of Health and Human Services, and Mark Esper, Secretary of Defense, are taking the lead.

Although a senior administration official is expected to be announced this week, Trump on Thursday, April 30, stated, “You know who is in charge of it? Honestly? I am.”

There are approximately 90 vaccine projects ongoing around the world. Currently the leaders appear to be the University of Oxford’s Jenner Institute, now backed by AstraZeneca, and U.S.-based Moderna, backed by the U.S. National Institutes of Allergy and Infectious Diseases (NIAID).

The Oxford group is launching a clinical trial in more than 6,000 people this month, with early data expected before June. Moderna is currently running its Phase I trial, which began dosing on March 16, with a second dosing started on March 23, with expansion into other sites at the end of the month, including in 60 adults over the age of 56, some in Seattle and Atlanta and Bethesda, Maryland.

The 14 chosen programs have not yet been identified.

Although both Moderna and Oxford have suggested they could get a vaccine available by September 2020, that’s a wildly optimistic timeline relying on everything going right. Although it seems likely Operation Warp Speed is including the Moderna trial, given the support by NIAID, there is no indication it is involved at any level with the Oxford group, which had indicated no agreements yet with U.S.-based biopharma organizations.

As The Washington Post wrote, the last time the U.S. government tried to dramatically accelerate a vaccine program, in 1976 for swine flu, it was “a fiasco.” Insurers and manufacturers were concerned about liability, causing Congress to pass a law waiving liability. One drug company manufactured two million doses with the wrong strain, and as the testing continued, more scientific problems emerged, including early studies showing it was not effective in children.

Eventually the vaccine was associated with cases of Guillain-Barre syndrome, then by 94 reports of paralysis, which resulted in the entire program being shut down. Guillain-Barre syndrome is an autoimmune disorder affecting the nerves.

Luckily, the swine flu did not spread as expected. “Had it done so,” Max J. Skidmore wrote in his book, “Presidents, Pandemics, and Politics,” “the swine flu vaccination program would immediately have been reinstituted.”

The risk-benefit analysis, he suggests, with a relatively small number of Guillain-Barre syndrome cases compared to the risk from the flu, would have changed the calculus.

Operation Warp Speed is projected to cost billions of dollars with the Trump Administration seemingly signing a blank check, with funds coming from pre-existing government funds. Reportedly, no congressional approval is needed.

CBS News noted, “The officials didn’t guarantee that any vaccine that comes out of the program would be free to all Americans though they suggested that could be part of the return on the government’s investment as part of the public-private partnership.”

Officials also speculated that once a vaccine was available, it would go first to nursing home facilities, first responders and other individuals who interact often with the public.

With vaccines of some firms already in the animal trial phase, developers say that if all goes well, India can have a vaccine by next year, ahead of the earlier timelines

As Chinese research firm may have made news by becoming the first organisation globally to enter phase-II of clinical trials to find a vaccine against the novel coronavirus disease (Covid-19) but Indian drugmakers are not far behind.

Six Indian drugmakers are in race to make a Covid-19 vaccine and, on basis of what these developers say, India may have a vaccine by next year as most candidates are already in animal-trial phase.

Gagandeep Kang, the vice-chair of the Coalition for Epidemic Preparedness Innovations, said Cadila Healthcare (Zydus Cadila), Serum Institute of India, Bharat Biotech, Indian Immunologicals, Mynvax, and Biological E are working to vaccines for Covid-19.

The first human trial in Europe of a coronavirus vaccine has begun in Oxford.

Two volunteers were injected, the first of more than 800 people recruited for the study.

Half will receive the Covid-19 vaccine, and half a control vaccine which protects against meningitis but not coronavirus.

The design of the trial means volunteers will not know which vaccine they are getting, though doctors will.

Elisa Granato, one of the two who received the jab, told the BBC: “I’m a scientist, so I wanted to try to support the scientific process wherever I can.”

The vaccine was developed in under three months by a team at Oxford University. Sarah Gilbert, professor of vaccinology at the Jenner Institute, led the pre-clinical research.

“Personally I have a high degree of confidence in this vaccine,” she said.

“Of course, we have to test it and get data from humans. We have to demonstrate it actually works and stops people getting infected with coronavirus before using the vaccine in the wider population.”

Prof Gilbert previously said she was “80% confident” the vaccine would work, but now prefers not to put a figure on it, saying simply she is “very optimistic” about its chances.

So how does the vaccine work?

The vaccine is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees that has been modified so it cannot grow in humans.

The Oxford team has already developed a vaccine against Mers, another type of coronavirus, using the same approach – and that had promising results in clinical trials.

How will they know if it works?

The only way the team will know if the Covid-19 vaccine works is by comparing the number of people who get infected with coronavirus in the months ahead from the two arms of the trial.

That could be a problem if cases fall rapidly in the UK, because there may not be enough data.

Prof Andrew Pollard, director of the Oxford Vaccine Group, who is leading the trial, said: “We’re chasing the end of this current epidemic wave. If we don’t catch that, we won’t be able to tell whether the vaccine works in the next few months. But we do expect that there will be more cases in the future because this virus hasn’t gone away.”

The vaccine researchers are prioritising the recruitment of local healthcare workers into the trial as they are more likely than others to be exposed to the virus.

A larger trial, of about 5,000 volunteers, will start in the coming months and will have no age limit. 

Older people tend to have weaker immune responses to vaccines. Researchers are evaluating whether they might need two doses of the jab.

The Oxford team is also working with researchers in Kenya about a possible vaccine trial there, where the rates of transmission are growing from a lower base.

If the numbers could be a problem, why not deliberately infect volunteers with coronavirus?

That would be a quick and certain way to find out if the vaccine was effective, but it would be ethically questionable because there are no proven treatments for Covid-19.

But that might be possible in the future. Prof Pollard said: “If we reach the point where we had some treatments for the disease and we could guarantee the safety of volunteers, that would be a very good way of testing a vaccine.”

Is it safe?

The trial volunteers will be carefully monitored in the coming months. They have been told that some may get a sore arm, headaches or fevers in the first couple of days after vaccination.

They are also told there is a theoretical risk that the virus could induce a serious reaction to coronavirus, which arose in some early Sars animal vaccine studies.

But the Oxford team says its data suggests the risk of the vaccine producing an enhanced disease is minimal, and data from animal studies has been positive.

Scientists there hope to have one million doses ready by September, and to dramatically scale up manufacturing after that, should the vaccine prove effective.

The Asia-Pacific’s largest specialist biotech CRO Novotech said biotech companies are currently initiating more clinical trials in Asia and Australia/New Zealand than in North America. The number of clinical trials initiated by biotechnology companies in Asia-Pacific since the beginning of March is about 10% higher than in the United States according to GlobalData. While the number for Phase 1 trials initiated in Asia-Pacific is twice that of North America, showing a clear willingness by sponsors to find alternative locations for clinical trials during the American slowdown.

Biotechnology sponsors are attracted to the region because sites have adapted well to the situation and are able to ensure clinical studies continuity. While Asia-Pacific is a key destination for COVID-19 trials, many sites and investigators are ensuring trial activity across all therapeutic areas, including oncology, metabolic disease and rare diseases.

Biotech Clinical Trial Continuity

There is high demand from biotechnology sponsors for studies in the Asia-Pacific region because of the speed and quality available here. Many biotech sponsors are now very familiar with the benefits of running clinical trials in Asia and Australia/New Zealand. While other sponsors are coming to the region because they were impressed with how efficiently sites have adapted to the new global situation.

Although the situation is rapidly evolving, countries across Asia-Pacific have showed low infection rates, high testing rates and low mortality compared to Western locations. Ethics and regulatory systems are operational in many locations, while remote monitoring is widely accepted. Private laboratories continue to support clinical trial activities.

A majority of sites continue to be very interested in new studies and recruitment continues especially in private sites.

South Korea in particular has handled the epidemic with one of the world’s most efficient and fast responses to reduce the virus spread. South Korea is known for some of the largest hospitals in the world which are also highly active in biotech clinical research. The number of hospital beds in South Korea is well over average and is about four times higher than the United States.

The Asia-Pacific’s largest specialist biotech CRO Novotech released sponsor bulletins detailing the clinical trial situation for each location in Asia-Pacific, including a situation update at key sites with strong experience in biotech-sponsored trials.

For the latest updates on the Asia-Pacific clinical trial landscape see our Data Bulletins (updated weekly). View and Download the COVID-19 Asia-Pacific Data Bulletins here.

Fast-tracking COVID-19 Trials

Many countries in the region are also now fast-tracking biotech COVID-19 clinical trials with expedited review processes for treatment and vaccine candidates. COVID-19 trials can be approved in just under 10 working days in South Korea and India for example. Over 350 clinical trials are currently occurring or planned across the Asia-Pacific region according to GlobalData.

Novotech has a rich experience handling biotech clinical trials across Asia-Pacific and is well positioned to implement rapid clinical studies in the region. Partnering with the right biotech CRO can help biotechnology companies find patients and contain the escalating costs of R&D with optimal study designs. Novotech is currently helping several biotechnology companies in the development of new COVID-19 therapies.

As more companies aim resources at COVID-19, a consortium launched the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified and limited patient-level data sets made available to public health and policy researchers to extract insights to help combat the pandemic.

The collaborators include Advarra, Berkeley Research Group, Datavant, OMNY, Parexel, Prognos Health, QIAGEN, SAS, Sumitomo Dainippon Pharma, Symphony Health, Veradigm, and Verana Health.

The database, which represents one of the largest public-private repositories of real-world data ever assembled, was developed to provide researchers and policymakers with something of a one-stop-shop for data relevant to the different kinds of research being conducted on COVID-19, the disease caused by the novel coronavirus that has brought most of the world to a halt. The COVID-19 Research Database contains a repository of real-world data, including medical claims, pharmacy claims, electronic health records and demographic data. It also integrates privacy-preserving patient linking technology and statistical certification, connecting data sources in a HIPAA-compliant manner to provide a more complete view of the patient journey, the consortium said this morning.

“Understanding and addressing COVID-19 is the challenge of our time,” Travis May, chief executive officer of San Francisco-based Datavant said in a statement this morning. May added that the collaboration that allowed for the creation of the database has been “inspiring.”

Researchers can access the COVID-19 Research Database via an analytic platform, enabling them to conduct large-scale studies while protecting patient privacy. In the announcement, some examples of the types of assessments that can be conducted using the COVID-19 Research Database were provided, including evaluations of drug effectiveness utilizing de-identified electronic health record and claims data, identifying which demographic factors and pre-existing conditions are most closely correlated with ventilator support or excess mortality, and measuring the public health impact of quarantine measures put in place in different geographies.

Researchers interested in accessing the database can submit a proposal to the Scientific Steering Committee. Researchers whose submissions are accepted can then access the database at no cost. Research findings can be submitted to and made available through peer-reviewed publications. 

Mark Cullen, professor of medicine at Stanford University and chairman of the steering committee, said the database, part of a massive public-private collaboration, “offers researchers a solution and a chance to dramatically accelerate our understanding of this highly infectious virus.” Cullen said one of the first challenges researchers have faced during the COVID-19 crisis has been the difficulty of accessing quality healthcare data that can answer important questions like treatment effects of certain drugs, as well as “factors that drive differential risk of catching the disease and very different outcomes in those who do.”

Thousands of patients have signed up in a few days to support a large-scale NHS trial for potential treatments for COVID-19 in the UK, one of the countries worst hit by the global pandemic.

The chief medical officers of England, Wales, Scotland, and Northern Ireland, have written to all doctors encouraging them to take part in a series of national randomised trials as the hunt for new medicines to treat the coronavirus pandemic continues apace.

RECOVERY tests what have become the ‘usual suspects’ in the effort against the coronavirus that causes COVID-19, although with more than 5,000 patients at more than 130 NHS hospitals it will be the largest of its kind in the world.

With that number of patients doctors will be able to see considerable details about efficacy and side effects of the various treatments, which are all approved for use with other diseases.

The trial has already recruited more than 1,000 patients within just 15 days and will test AbbVie’s HIV drug Kaletra (lopinavir+ritonavir), the anti-inflammatory steroid dexamethasone, the anti-malarial drug hydroxychloroquine, the antibiotic azithromycin, and Roche’s anti-inflammatory agent Actemra (tocilizumab).

Kaletra has already been tested in China on coronavirus patients, with mixed results, and a series of trials produced inconclusive data on hydroxychloroquine at the end of last week.

Trial data will be reviewed regularly so any effective treatment can be identified and quickly made available to patients.

The RECOVERY trial team will also review information on new drugs and include promising ones in the trial.

The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR).

There is also core funding from several other organisations including the NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation.

The news comes after Gilead announced last week that it had to curtail two China-based trials of its unapproved remdesivir, because as the pandemic subsides in the country of its origin there are not enough patients to recruit for trials.

Johanna Swanson, product manager at analysts GlobalData said: “With more patients being enrolled and treatments being examined, we will get a better view of what is working for the differing levels of illness severity. The rapidity at which these studies are being launched provides some hope for faster results. We expect some safety and effectiveness data within the coming months.”

VivoPlex Group has been given the go-ahead by the UK regulator to start the first clinical feasibility study of its uterine sensor system as a tool to help women with fertility problems.

The wireless and battery-free monitor device – roughly the same size as a coil for birth control – is inserted into the uterus and measures temperature, pH, and oxygen levels over a period of up to seven days.

The aim is to gauge the environment within the womb to help guide doctors in the timing and selection of  fertility treatments that can improve the chances of successful in-vitro fertilisation (IVF), and could potentially provide cost savings.

“These parameters are deemed crucial in embryo development and are tightly controlled within the incubators used in…IVF laboratories,” says the Oxford-based company.

Power for the sensor comes from a wearable device in the form of a washable pair of briefs that also receives data signals from the device, which can then be transmitted via a software link to a clinical specialist.

It is estimated that infertility affects one in seven heterosexual couples in the UK, with a slight increase in recent years, according to data from the National Institute for Health and Care Excellence (NICE). The rate of infertility is climbing slightly, mainly because women are having children when they are older.

Factors in males account for around 30% of cases, with another 25% unexplained. Ovulatory disorders are seen in around 25% of cases, with damage to the fallopian tubes and uterine or peritoneal disorders making up 20% and 10%, respectively.

The clinical feasibility study of the VivoPlex sensor will involve 20 women and be carried out at the University of Southampton, from which the company was spun out in 2015. It raised £3 million ($3.7 million) in first-round financing last year.

It will get going as soon as clinical capacity becomes available after the coronavirus pandemic starts to resolve, according to the firm.

VivoPlex will use the data generated in the pilot study to decide on the design of future trials that could support European approval via the CE mark regulatory pathway.

If all goes well in the studies, VivoPlex hopes to launch the device first in Europe, followed by the US, Australia, New Zealand and Japan. The potential market in those regions is estimated at around 660,000 patients per year.