Tag: Clinical Trials

Researchers Debate Infecting People With Coronavirus to Test Vaccines

One way to quickly see if a coronavirus vaccine works would be to immunize healthy people and then deliberately expose them to the virus, some researchers are suggesting. Proponents say this strategy, called a human challenge trial, could save time because rather than conducting tests the usual way — by waiting for vaccinated people to […]

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Breakthrough Drug for Covid-19 May Be Risky for Mild Cases

Scientists in Britain announced a major breakthrough in the battle against the coronavirus last week, reporting they had found the first drug to reduce deaths among critically ill Covid-19 patients. The results were first made public in a sparsely detailed news release. Now the full study, neither peer reviewed nor published yet, has been posted […]

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Sanofi Accelerates Its Timeline for Coronavirus Vaccine Development

After lagging behind its competitors in starting clinical trials, the French drugmaker Sanofi has announced plans to speed a vaccine development timeline that could yield approval from regulatory authorities sometime next year, perhaps in the first half of 2021, the company announced on Tuesday. The company and its partner in the endeavor, GlaxoSmithKline, originally projected […]

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Federal Agency Halts Studies of Hydroxychloroquine, Drug Trump Promoted

The National Institutes of Health said Saturday that it had stopped two clinical trials of hydroxychloroquine, the malaria drug that President Trump promoted to treat and prevent the coronavirus, one because the drug was unlikely to be effective and the other because not enough patients signed up to participate. The agency halted a trial that […]

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Older Adults May Be Left Out of Some Covid-19 Trials

Picture the day — in six months, a year and a half or in 2023 — when university researchers or a pharmaceutical company announces a breakthrough against the virus that causes Covid-19. Maybe it’s a successful vaccine or an effective treatment, a discovery that brings hope and relief — especially to the older adults most […]

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Coronavirus Attacks the Lungs. A Federal Agency Just Halted Funding for New Lung Treatments.

When the coronavirus kills, it attacks the lungs, filling them with fluid and robbing the body of oxygen. In chest X-rays, clear lungs turn white, a sign of how dangerously sick patients are. But earlier this month, the Biomedical Advanced Research and Development Authority, or BARDA, a federal health agency, abruptly notified companies and researchers […]

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Facebook open-sources AI for clinical trial eligibility

As trials for novel coronavirus drugs, therapies, and vaccines kick off in countries around the world, Facebook researchers are making available a library of AI models that transform clinical trial screening criteria into a machine-readable format. They say that the code enables trials to be searched by their health requirements, making it easier for people […]

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Dexamethasone Reduces Coronavirus Deaths, Scientists Say

LONDON — In an unexpected glimmer of hope amid an expanding pandemic, scientists at the University of Oxford said on Tuesday that an inexpensive and commonly available drug reduced deaths in patients with severe Covid-19, the illness caused by the coronavirus. If the finding is borne out, the drug, a steroid called dexamethasone, would be […]

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Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers

Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14. Together, the sisters make up about 5 percent of the first ever clinical trial of a […]

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Could Trump Turn a Vaccine Into a Campaign Stunt?

Oct. 23, 2020, 9 a.m., with 10 days before the election, Fox New releases a poll showing President Trump trailing Joe Biden by eight percentage points. Oct. 23, 2020, 3 p.m., at a hastily convened news conference, President Trump announces that the Food and Drug Administration has just issued an Emergency Use Authorization for a […]

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Trump Narrows Search for Coronavirus Vaccine to Five Firms

WASHINGTON — The Trump administration has selected five companies as the most likely candidates to produce a vaccine for the coronavirus, senior officials said, a critical step in the White House’s effort to deliver on its promise of being able to start widespread inoculation of Americans by the end of the year. By winnowing the […]

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Scientists Question Major Hydroxychloroquine Study

More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded that treating people who have Covid-19 with chloroquine and hydroxychloroquine did not help and might have increased the risk of abnormal heart rhythms and death. In an […]

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Scientists Question Validity of Major Hydroxychloroquine Study

More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded the use of chloroquine and hydroxychloroquine to treat people with Covid-19 did not help and may have increased the risk of abnormal heart rhythms and death. Use […]

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Coronavirus Vaccine Shows Promising Early Results in China

A vaccine developed in China appears to be safe and may protect people from the new coronavirus, researchers reported on Friday. The early-stage trial, published in the Lancet, was conducted by researchers at several laboratories and included 108 participants aged 18 to 60. Those who received a single dose of the vaccine produced certain immune […]

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How Upbeat Vaccine News Fueled a Stock Surge, and an Uproar

When the biotech company Moderna announced early on Monday morning positive results from a small, preliminary trial of its coronavirus vaccine, the company’s chief medical officer described the news as a “triumphant day for us.” Moderna’s stock price jumped as much as 30 percent. Its announcement helped lift the stock market and was widely reported […]

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Treating Mild Coronavirus Cases Could Help Save Everyone

The president’s decision is puzzling. And yet it does highlight the urgent need to devote more attention and resources to drugs that can prevent Covid-19 or stop mild cases from getting worse. To date, about a dozen studies on therapies for Covid-19 have been published; all were conducted on hospitalized patients, typically with severe symptoms. […]

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$1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine

The deal with AstraZeneca is the fourth and by far the largest vaccine research agreement that the department has disclosed. The money will pay for a Phase 3 clinical trial of a potential vaccine in the United States this summer with about 30,000 volunteers. The H.H.S. statement said the agency and AstraZeneca “are collaborating to […]

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What to Expect When a Coronavirus Vaccine Finally Arrives

On a spring morning in 1955, a pair of press officers greeted a mob of reporters in a stately hall on the University of Michigan campus. The officers had hot news: A clinical trial of the long-awaited polio vaccine had proved it to be safe and effective. The reporters nearly rioted in their scramble to […]

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What to Expect When a Coronavirus Vaccine Finally Arrives

On a spring morning in 1955, a pair of press officers greeted a mob of reporters in a stately hall on the University of Michigan campus. The officers had hot news: A clinical trial of the long-awaited polio vaccine had proved it to be safe and effective. The reporters nearly rioted in their scramble to […]

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A New Entry in the Race for a Coronavirus Vaccine: Hope

In a medical research project nearly unrivaled in its ambition and scope, volunteers worldwide are rolling up their sleeves to receive experimental vaccines against the coronavirus — only months after the virus was identified. Companies like Inovio and Pfizer have begun early tests of candidates in people to determine whether their vaccines are safe. Researchers […]

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Prototype Vaccines Protect Monkeys From Coronavirus

A prototype vaccine has protected monkeys from the coronavirus, researchers reported on Wednesday, a finding that offers new hope for effective human vaccines. Scientists are already testing coronavirus vaccines in people, but the initial trials are designed to determine safety, not how well a vaccine works. The research published Wednesday offers insight into what a […]

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Amid Hydroxychloroquine Uproar, Real Studies of Drug Are Suffering

WASHINGTON — President Trump’s enthusiastic embrace of a malaria drug that he now says he takes daily without proof that it is effective against Covid-19 — and the resulting uproar in the news media — appears to be interfering with legitimate scientific research into whether the medicine might work to prevent coronavirus infection or treat […]

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The Risks of Trump’s Hydroxychloroquine Hype

President Trump revealed on Monday that despite warnings from the Food and Drug Administration, he said he has been taking hydroxychloroquine for about a week and a half as a preventive measure. The F.D.A. warnings about hydroxychloroquine (and the related drug chloroquine) follow studies of the drug that have so far largely proved disappointing. While […]

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What to Know About Hydroxychloroquine

President Trump revealed on Monday that he had been taking an anti-malaria drug as a preventive measure against the coronavirus, the same medicine that he has been promoting for two months with scant evidence of its efficacy and despite several warnings of dangerous side effects. The drug, hydroxychloroquine, has been invoked by Mr. Trump repeatedly […]

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What to Know About the Malaria Drug Trump Is Using

President Trump revealed on Monday that he had been taking an anti-malaria drug as a preventive measure against the coronavirus, the same medicine that he has been promoting for two months with scant evidence of its efficacy and despite several warnings of dangerous side effects. The drug, hydroxychloroquine, has been invoked by Mr. Trump repeatedly […]

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Can ‘Team Science’ Yield a Covid-19 Treatment?

ImageCredit…Illustration by Ori Toor Xin Yin was excited to be visiting his parents in the Shandong Province of China last December. Yin, a researcher in the Immunity and Pathogenesis Program at the Sanford Burnham Prebys Medical Discovery Institute in California, hadn’t been home in five years. So much had changed since then — a new […]

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Low-Tech Way to Help Some Covid Patients: Flip Them Over

Hospitals across the country are filled with a curious sight these days: patients lying on their bellies. Patients almost always lie on their backs, a position that helps nurses tend to them and allows them to look around if they’re awake. But for many patients, the coronavirus crisis is literally flipping the script. The surprisingly […]

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A Drug Cocktail Hastens Recovery in Some Coronavirus Patients

With vaccines still months, maybe years, into the future, researchers are rushing to determine whether existing drugs can be used to treat the coronavirus. In the United States, only one — remdesivir — has been shown to be effective in speeding recovery. In the new study, published in The Lancet, researchers at six public hospitals […]

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Haphazard Rollout of Coronavirus Drug Frustrates Doctors

When the Food and Drug Administration granted an emergency approval last week for an antiviral drug, remdesivir, to treat hospitalized coronavirus patients, many doctors were overjoyed. The drug is the first shown to be even mildly effective against the virus. But bafflement soon followed as doctors and hospitals tried to obtain the drug. Small community […]

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Moderna Gets OK to Start Larger Trial for a Coronavirus Vaccine

One of the first biotech companies to begin human trials of an experimental vaccine for the coronavirus is now ready to move onto the next phase of testing. On Thursday, Moderna announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people. “The imminent Phase […]

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China’s Coronavirus Vaccine Drive Empowers a Troubled Industry

Desperate to protect its people and to deflect growing international criticism of how it handled the outbreak, it has slashed red tape and offered resources to drug companies. Four Chinese companies have started testing their vaccine candidates on humans, more than the United States and Britain combined. But China’s leaders have empowered a vaccine industry […]

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