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WHO launches mega-trial of four of the most promising drugs against COVID-19 – ZME Science

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It almost seems like a Hollywood cliche — a ragtag team of existing drugs team up to defeat a threat that puts the whole world at risk.

The team members? An old malaria treatment dating from the ’40s, a drug combo used against HIV, and a treatment against Ebola that never really took off. The race is on.

In our battle against COVID-19, developing new treatments and vaccines is paramount. But the problem is that these trials usually take years and years, and as much as you accelerate things, it will still take over a year (under optimistic conditions).

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This is why researchers are intensely studying already-existing drugs — because we already know they’re safe. It’s also not unreasonable to expect drugs that work for one thing to work for another. There’s no guarantee, of course, but researchers have some good hunches.

Already, word of preliminary results (some of which are optimistic) have made it through the media. Trump’s praise of chloroquine, in particular, ignited hope that this could be, as Trump put it, a “game changer”. But Trump’s statement is premature at best.

In Nigeria, Trump’s statements triggered a frenzy, and three people were hospitalized after ingesting too much chloroquine. Anthony Fauci, the doctor overseeing the COVID-19 outbreak in the US, was quick to correct Trump and say that there is no “evidence” other than “anecdotal evidence” — and when it comes to a treatment, anecdotal evidence doesn’t really cut it.

This is why we need large clinical trials to test these drugs. Of course, speed is essential, but scientific rigor must also be ensured: we need to know that a drug is safe and effective before deploying it.

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If we want to find drugs that slow or kill the novel coronavirus, or that can be given prophylactically to protect healthcare workers from the risk of infection, or even to reduce the time necessary in intensive care units, trials like these are our best bets.

So the World Health Organization has announced a large global randomized trial, called SOLIDARITY, to test some of the most promising drugs. The design is not double-blind (so placebo effects cannot be ruled out), but it will be very easy for doctors to enroll patients in the study. When a person is eligible, all the physician needs to do is enter the patient’s data into a WHO website, including any health information that might be a consideration. Then, a consent form will be printed out. This form is scanned and sent to the WHO in any electronic form. The doctors can then mention which drugs are available at their hospital, and the website will randomize the patient on one of the drugs available.

It’s a huge effort made with the goal of being accessible for everyone in the world. Here are the drugs that will be tested:

Chloroquine and hydroxychloroquine

Information about these drugs has been somewhat contradictory. The drugs were designed as treatments for malaria during World War II. It was one of the first promising research avenues against COVID-19, but the WHO had initially planned to leave them out of the SOLIDARITY trial.

However, they changed their mind because the drugs “received significant attention” in many countries, which prompted “the need to examine emerging evidence to inform a decision on its potential role.”

It’s not the first time the drugs were considered for a different purpose, after being tested for dengue and chikungunya — but the results were not encouraging at all. Furthermore, the drugs are also toxic in high quantities.

Much of the support for these two substances comes from a Chinese report on 100 patients, but the data for that study has not yet been revealed. Several studies published in China have been similarly murky. Hopefully, the data will clarify with this trial.

Remdesivir

Remdesivir is another promising compound. Initially developed by Gilead Sciences to combat Ebola and related viruses, Remdesivir did not really seem to work against Ebola — but subsequent trials found that it can inhibit the viruses causing SARS and MERS, two other coronaviruses.

There are several anecdotes about COVID-19 patients receiving Remdesivir and making a quick recovery, but again, the data is not clear. Furthermore, Remdesivir is an intravenous drug and it’s pretty expensive — and seems to work best when patients exhibit low levels of symptoms.

Ritonavir/lopinavir

This combination drug (sold under the name Kaletra) was sold in the US starting in 2000. Kaletra is used to treat HIV infections.

The drug is generally safe, but can interfere with other drugs. It remains to be seen just how effective it is against COVID-19.

Ritonavir/lopinavir and interferon-beta

In addition, the SOLIDARITY trial will also analyze the above-mentioned combination, administered alongside interferon-beta: a molecule used for regulating inflammation.

Here, too, safety must be first established, as the combination can cause liver damage.

Overall, the entire trial is very robust and may change along the way as new evidence pops up. Already, multiple countries from all around the world have signed up for it, which is encouraging.

It’s more important than ever to have access to clinical data as early as possible, especially if we want to have a treatment against COVID-19 as soon as possible.

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Newfoundland and Labrador releases coronavirus projections – The Globe and Mail

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Newfoundland and Labrador Health Minister John Haggie in Winnipeg on June 28, 2018.

John Woods/The Canadian Press

Models projecting the impact of the COVID-19 pandemic in Newfoundland and Labrador suggest cases could peak around mid-November and ICU bed capacity could be exceeded by mid-July if current preventive measures remain in place.

That scenario, run by the Canadian Institute for Health Information, looked at the possibility that 32 per cent of the population would be infected with COVID-19 over two years.

Health Minister John Haggie, Premier Dwight Ball and Janice Fitzgerald, the province’s chief medical officer of health, addressed the province by video on Wednesday along with Dr. Proton Rahman, a clinical scientist and professor of medicine at Memorial University of Newfoundland.

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The presentations showed that, even with a rapid rise in cases over the last month due to a cluster that spread from a funeral home, the curve of the outbreak has been flattening over the last week.

It’s now similar to other provinces such as British Columbia, suggesting public health measures like contact tracing and non-essential service shutdowns have been effective so far.

The funeral home cluster, which represents 75 per cent of the province’s known cases, created a challenge for modelling, officials said.

Two people have died from COVID-19 in Newfoundland and Labrador, making the sample too small to project for a possible number of deaths.

In the short term, the Newfoundland and Labrador Centre for Health Information projects that under current measures, a “best case” scenario would see approximately 25 hospitalizations due to the illness by April 30.

In a “worst case” scenario, without public health measures, approximately 200 people would be hospitalized by April 30. Both scenarios are manageable with the province’s current bed capacity, the projections note.

Projections related to ICU beds, which looked at 57 of 98 ICU beds as available, predicted that a best-case scenario would see about 10 patients occupying intensive care beds by April 30.

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In a worst-case scenario, the province would exceed its ICU capacity by the same date, with approximately 65 people in ICU beds with COVID-19.

Assuming 32 per cent of the population contracts the illness, the Canadian Institute for Health Information predicts that Newfoundland and Labrador will need more ICU beds by July.

However, the same model predicted the province would stay within its acute care and ventilator capacity over the next year.

Another scenario, in which 51 per cent of the population contracts COVID-19, cases would peak in September, ventilator supply would be exceeded by mid-July and ICU capacity would be exceeded in mid-June. Acute care needs would exceed capacity in July in that scenario.

Newfoundland and Labrador has the second-highest number of infections per capita across Canadian provinces and territories, after Quebec, according to the presentation that used numbers from Tuesday.

Among the 17 people hospitalized, six have gone into the ICU.

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The province reported four new confirmed cases of COVID-19 on Wednesday, bringing the provincial total to 232.

The Newfoundland and Labrador government shared models forecasting the impact of the COVID-19 pandemic on Wednesday. If one-third of the population were infected over two years, one scenario predicted cases could peak in November and ICU bed capacity could be exceeded in July. The Canadian Press

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Saskatchewan Health Authority released health system readiness model for COVID-19 – Assiniboia Times

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The Saskatchewan Health Authority (SHA) released their health system readiness model on Wednesday during a presentation covering varied outcomes for different levels of the COVID-19 outbreak in Saskatchewan.

The presentation used three separate variable models of different varieties to show the impact the outbreak could have on Saskatchewan’s healthcare system. The SHA said the dynamic modelling is not a prediction, it provides a range of ‘what if’ scenarios to guide planning going forward.

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The modelling scenarios were based on our best knowledge at this time and will continue to be updated with Saskatchewan data. For all three scenarios, the key variable used to predict numbers were a high range, meaning one person could infect up to four people with the virus, a mid range where one person could infect 2.76 and a low range where one could infect 2.4.

According to the SHA, in a high-range estimate, 4,265 COVID-19 patients are required in acute care. Of those hospitalized, 1,280 COVID-19 patients will be in the ICU with 90-95 per cent requiring ventilation.

On the low side, the SHA presentation said at peak, 390 patients are in an acute care simultaneously. Of those hospitalized, 120 patients will be in the ICU with 90-95 per cent requiring ventilation.

According to the SHA’s presentation, on the high end of the model, the province could see up to 408,000 total cases with 215 ICU admissions daily and a cumulative total of 8,370 deaths. On the low end, there’s 153,000 total cases with 20 ICU admissions daily and up to 3,075 deaths.

The SHA believed the current demand for daily ICU across Saskatchewan would be 57 beds with 98 total capacity. For acute care, there might be a daily demand of 1,396 with a total capacity of 2,433.

The SHA’s model reported an estimated total of 890 ICU patients at peak across the province. The model added the co-ordinated provincial approach for critical care patients from rural and north Saskatchewan to be admitted to urban sites when local ICU capacity was exceeded.

In addition, the SHA currently has 450 ventilators available to meet COVID-19 model demands for low and mid-range scenarios. The planned capacity ventilator requirement of 860 created a gap of 410, but the SHA added there are confirmed orders for 200 with 100 expected n the next two to three weeks.

The SHA said they are basing their response to COVID-19 on a strategy of contain, delay, mitigate and population health promotion. Their desired goal is to promote health, prevent disease and ensure healthcare services remain available. The SHA also said their key strategies for public health were to increase testing, identify cases early, expand contact tracing and enforce chief medical health officer orders.

The key strategies to further the SHA’s approach include expanding Healthline, delivering more services through virtual care models of which 750 clinicians are set up and expanding testing and assessment centres.

There are currently 38 SHA operated testing sites across the province, five assessment sites in operation with 21 planned to open in coming weeks.

 

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ICU beds main challenge in COVID-19 projections – The Telegram

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ST. JOHN’S, N.L. —

Peter Jackson

Local Journalism Initiative Reporter

The short-term outlook for COVID-19 spread in Newfoundland and Labrador looks promising under current health emergency measures.

But even the best-case long-term projections suggest a likely squeeze for intensive care unit (ICU) beds by the fall.

The projections were presented to reporters and to the public Wednesday by Dr. Proton Rahman, a clinical scientist with Eastern Health. The information was assembled through various local agencies with help from the University of Toronto and the Canadian Institute of Health Information (CIHI).

Even with current emergency health measures, long-term modelling showed the province needing about 200 ICU beds at peak coronavirus levels in November. That’s three times what is currently available, although there would still be enough ventilators.

Overall bed capacity would not be exceeded in this scenario, but Rahman said ICU care depends primarily on the number of nurses and specialists available.

“It’s not just about beds,” he said. “With each individual bed there’s human resources involved, such as respiratory technicians, which is going to be critical to this. We really have to rethink, to some extent, how to deliver these services.”

A more dire scenario presented Wednesday, in which half the population got sick, showed catastrophic results, with not nearly enough beds, staff or ventilators to go around.

“We will simply not be able to cope without drastic changes, and even then it is unlikely we would be successful,” Health Minister Dr. John Haggie said during a later video address.

Insufficient data

Rahman warned that the CIHI models are likely “off a fair bit.”

“We’re looking well beyond the time frame that we have any certainty about.”

He said Newfoundland and Labrador is at least three weeks behind other provinces in terms of usable date.

In particular, while tragic in themselves, the fact there has only been two deaths so far makes it impossible to offer accurate projections of mortality rates.

He said the higher rates of high blood pressure and diabetes in this province don’t bode well, since those underlying conditions increase the chance of severe symptoms or death.

But the virus can affect anyone.

“The experience that’s been reported in numerous states in America and also in Canada (is that) a lot of young, healthy people are actually ending up in the ICU. Most don’t, but it can happen to anyone,” Rahman said. “The people that we’re worried about the most are the old, the vulnerable, people with multiple medical conditions, but anyone can get in trouble and you really have to respect what this virus can do.”

Rahman said the Caul’s Funeral Home cluster — a mid-March exposure that accounts for 75 per cent of subsequent COVID-18 hospitalizations — also makes it difficult to interpret the province’s numbers with any accuracy.

Models are usually based on more evenly distributed infections.

Buying time

Rahman said emergency measures imposed by the province could buy time to accommodate demand ahead of the surge.

“The time is key in terms of the health care capacity to be able to manage large amounts of patients,” he said. “The other reason why time is important, if we’re looking at an 18-month to two-year time period, lots could happen in terms of maybe a potential therapy, something that’s been repurposed in terms of a drug coming into it, some antibodies that you can take or possibly a vaccine. You’re buying time for potentially a therapy and you’re also buying time in terms of our health care capacity to adapt to this.”

Rahman wouldn’t speculate on how long current health measures would be in place, especially if the peak doesn’t arrive until November.

But he cited a scenario posed by some experts in which individual measures could be lifted temporarily and re-imposed if the number of cases rises again.

Chief Medical Officer of Health Dr. Janice Fitzgerald was not available for questions during the Wednesday evening briefing.

For now, Rahman said, it’s important to stay put.

“It just takes one small indiscretion to create a large increase,” he said.

“So, please, please follow the health guidelines put in place by Dr. Fitzgerald.”

With files from David Maher

Peter Jackson is a Local Initiative Reporter covering health care for The Telegram

peter.jackson@thetelegram.com

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