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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.

Italian researchers have claimed that they have successfully developed a vaccine to contain coronavirus (COVID-19) which is likely to work on humans, a report said.

Luigi Aurisicchio, CEO of Takis, the firm developing the medication, said that a coronavirus candidate vaccine has neutralised the virus in human cells for the first time, the Arab News reported.

"This is the most advanced stage of testing of a candidate vaccine created in Italy. Human tests are expected after this summer," Aurisicchio was quoted as saying to Italian news agency ANSA.

"According to the Spallanzani Hospital, as far as we know we are the first in the world so far to have demonstrated neutralisation of the coronavirus by a vaccine. We expect this to happen in humans too," he added.

The researchers experimented with the vaccine on mice that had successfully developed antibodies that blocked the virus from infecting the cells. They further observed that the five vaccine candidates generated a large number of antibodies, and selected two with the best results.

All of the vaccine candidates currently being developed are based on the genetic material of DNA protein "spike", the molecular tip used by the coronavirus to enter human cells.

They are injected with the so-called "electroporation" technique, which consists of an intramuscular injection followed by a brief electrical impulse, helping the vaccine break into the cells and activating the immune system, the report said.

Researchers believe that this makes their vaccine particularly effective for generating functional antibodies against the "spike" protein, in particular in the lung cells, which are the most vulnerable to coronavirus.

"We are working hard for a vaccine coming from Italian research, with an all-Italian and innovative technology, tested in Italy and made available to everyone," Aurisicchio was quoted by the Arab News report.

"In order to reach this goal, we need the support of national and international institutions and partners who may help us speed up the process," he noted.

The total number of COVID-19 infections, fatalities and recoveries since the pandemic began has risen to 213,013 in the country.

Geneva, Mar 30: The number of confirmed COVID-19 cases worldwide has reached 634,835, among them 29,957 fatalities, the World Health Organization (WHO) said on Sunday.

Over the past 24 hours, 63,159 people were confirmed to be infected with the novel coronavirus and 3,464 people died, the WHO said.

According to the latest situation report, the majority of the confirmed cases - more than 361,000 - are presently concentrated in Europe, with Italy leading the tally with over 92,000 cases, followed by Spain with over 72,000 cases, and Germany with over 52,000 cases.

Italy and Spain are also the countries that top the worldwide death toll from COVID-19, with 10,023 and 5,690 fatalities, respectively.

The second most affected region is currently the Americas with over 120,000 verified COVID-19 cases, of which the majority - over 103,000 - have been found in the United States. The US is also the country with the highest single tally of COVID-19 cases at the moment.
The WHO declared COVID-19 a pandemic on March 11.