The Women in White, Seated Together At Trump's State of the Union Address

Jun 4: A malaria drug President Donald Trump took to try to prevent COVID-19 proved ineffective for that in the first large, high-quality study to test it in people in close contact with someone with the disease.

Results published Wednesday by the New England Journal of Medicine show that hydroxychloroquine was no better than placebo pills at preventing illness from the coronavirus.

The drug did not seem to cause serious harm, though -- about 40% on it had side effects, mostly mild stomach problems.

 “We were disappointed. We would have liked for this to work,” said the study leader, Dr. David Boulware, an infectious disease specialist at the University of Minnesota.

“But our objective was to answer the question and to conduct a high-quality study,” because the evidence on the drug so far has been inconclusive, he said.

Hydroxychloroquine and a similar drug, chloroquine, have been the subject of much debate since Trump started promoting them in March.

Hydroxychloroquine has long been used for malaria, lupus, and rheumatoid arthritis, but no large studies have shown it or chloroquine to be safe or effective for much sicker patients with coronavirus, and some studies have suggested the drugs may do harm.

Trump took a two-week course of hydroxychloroquine, along with zinc and Vitamin D, after two staffers tested positive for COVID-19, and had no ill effects, according to results of his latest physical released by his doctor Wednesday.

Federal regulators have warned against hydroxychloroquine's use except in hospitals and formal studies because of the risk of side effects, especially heart rhythm problems.

Boulware's study involved 821 people in the United States and Canada living with someone diagnosed with COVID-19 or at high risk of getting it because of their job -- doctors, nurses, ambulance workers who had significant exposure to a sick patient while not wearing full protective gear.

They were randomly assigned to get either the nutrient folate as a placebo or hydroxychloroquine for five days, starting within four days of their exposure. Neither they nor others involved in the research knew who was getting which pills.

After 14 days in the study, 12 per cent on the drug developed COVID-19 symptoms versus 14 per cent in the placebo group, but the difference is so small it could have occurred by chance, Boulware said.

“There's basically no effect. It does not prevent infection,” he said of the drug. Even if it were to give some slim advantage, “we'd want a much larger effect” to justify its use and risk of side effects for preventing illness, he said.

Results were no different among a subgroup of participants who were taking zinc or vitamin C, which some people believe might help make hydroxychloroquine more effective or fight the coronavirus.

There are some big caveats: The study enrolled people through the Internet and social media, relying on them to report their own symptoms rather than having them tracked in a formal way by doctors.

Participants were not all tested for the coronavirus but were diagnosed as COVID-19 cases based on symptoms in many cases. And not all took their medicines as directed.

The results “are more provocative than definitive,” and the drug may yet have prevention benefits if tried sooner or in a different way, Dr. Myron Cohen of the University of North Carolina at Chapel Hill wrote in a commentary in the journal.

Others were glad to see a study that had a comparison group and good scientific methods after so many weaker reports on hydroxychloroquine.

“This fits with everything else we've seen so far which suggests that it's not beneficial," said Dr. Peter Bach, director of a health policy center at Memorial Sloan Kettering Cancer Center in New York.

This study was in younger relatively healthy people, but the results “would make me very discouraged about trying to use this in older people” who are most vulnerable to serious illness from the coronavirus, Bach said.

“If it does work, it doesn't work very well.” Dr. Dan Culver, a lung specialist at the Cleveland Clinic, said there's still a chance that giving the drug sooner than four days after someone's exposure to the virus may help prevent illness.

But the study “takes 'home run' off the table” as far as hopes for the drug, he said.

The study was mostly funded by David Baszucki, founder of Roblox, a California-based game software company, and other private donors and the Minnesota university.

Boulware also is leading a study testing hydroxychloroquine for treating COVID-19. The study is finished and results are being analyzed now.

On Tuesday, the journal Lancet posted an “expression of concern” about a study it published earlier this month of nearly 15,000 COVID-19 patients on the malaria drugs that tied their use to a higher risk of dying in the hospital or developing a heartbeat problem.

Scientists have raised serious questions about the database used for that study, and its authors have launched an independent audit.

That work had a big impact: the World Health Organization suspended use of hydroxychloroquine in a study it is leading, and French officials stopped the drug's use in hospitals. On Wednesday, the WHO said experts who reviewed safety information decided that its study could resume.

Canadian researchers are developing a DNA vaccine for SARS-CoV-2, the coronavirus that causes COVID-19 and has currently infected nearly 5,00,000 people worldwide and crippled the global economy.

Entos Pharmaceuticals, a health-care biotechnology company headed by a University of Alberta researchers, develop new therapeutic compounds using the company's proprietary drug-delivery platform and has begun manufacturing vaccine candidates against the novel coronavirus.

"Given the urgency of the situation, we can have a lead candidate vaccine within two months. Once we have that it's a race to get it into clinical trials," said John Lewis, CEO of Entos and a Professor at the University of Alberta in Canada.

Lewis said in comparison to a traditional vaccine, DNA-based vaccines hold several advantages.

Nucleic acids are introduced directly into the patient's own cells, causing them to make pieces of the virus--tricking the immune system into mounting a response without the full virus actually being present, the researcher said.

According to the company, the approach is recognised as being easier to move into large-scale manufacturing, offers improved vaccine stability and works without needing an infectious agent.

In the current absence of a vaccine for COVID-19, several companies around the world are mounting efforts to begin similar work.

The first clinical trial using a DNA-based vaccine developed by Moderna Inc.in the US on March 13.

Their approach allows for antibodies to be made in the human trial volunteers against a specific protein on the surface of the coronavirus that lets the virus enter human cells.

The hope is that the antibodies will stop the interaction.

Though this approach is designed to be effective against COVID-19 specifically, Lewis said Entos is taking a different tack.

The company plans to use plasmid DNA to amplify the production of key coronavirus surface and structural proteins with each injection, with an eye to the bigger picture.

"Many of the structural proteins in the virus are pretty well conserved across all the coronaviruses, including SARS and MERS," said Lewis.

"We're hoping that if we express more of the structural proteins that are common to most coronaviruses, we can inhibit the current COVID-19, and also potentially protect against all coronaviruses both past and future," Lewis added.

To move the project forward quickly, the company is seeking financial support from both provincial and federal levels of government.

"We have the opportunity to save a lot of lives, and I think it's really upon us and governments to find solutions for that," Lewis said.

May 15: Global deaths linked to the novel coronavirus passed 300,000 on Thursday, while reported cases of the virus are approaching 4.5 million, according to a news agency tally.

About half of the fatalities have been reported by the United States, the United Kingdom and Italy.

The first death linked to the disease was reported on January 10 in Wuhan, China. It took 91 days for the death toll to pass 100,000 and a further 16 days to reach 200,000, according to the Reuters tally of official reports from governments. It took 19 days to go from 200,000 to 300,000 deaths.

By comparison, an estimated 400,000 people die annually from malaria, one of the world’s most deadly infectious diseases.

The United States had reported more than 85,000 deaths from the new coronavirus, while the United Kingdom and Italy have reported over 30,000 fatalities each.

While the current trajectory of COVID-19 falls far short of the 1918 Spanish flu, which infected an estimated 500 million people, killing at least 10% of patients, public health experts worry the available data is underplaying the true impact of the pandemic.