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British researchers find no benefit for hydroxychloroquine in COVID-19

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June 5 (UPI) — Hydroxychloroquine offers “no beneficial effect” in hospitalized patients with COVID-19, researchers at the University of Oxford In England announced Friday.

Just over one in four patients who received the anti-malaria drug died within 28 days of starting treatment, while slightly less than one in four of those who received usual care — basically supportive management of heart and lung symptoms — died within that time frame, researchers heading up the RECOVERY trial said.

The findings are based on an analysis of data from 80 percent of the study participants, they said.

“These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalized with COVID-19,” they said in a statement. “Full results will be made available as soon as possible,” they said.

“There has been huge speculation and uncertainty about the role of hydroxychloroquine as a treatment for COVID-19, but an absence of reliable information from large randomized trials,” Dr. Martin Landray, one the principle investigators, said in a statement.

The announcement of the findings comes just one day after the authors of two studies published in the Lancet and the New England Journal of Medicine chose to retract their published research due to alleged issues with the data source.

The two retracted studies had also concluded that hydroxychloroquine offered “no clinical benefit” in patients infected with the new coronavirus, SARS-CoV-2. They also linked the drug with significant heart-related side effects.

“Today’s preliminary results from the RECOVERY Trial are quite clear — hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease,” said Landray, who is a professor of medicine and epidemiology at the University of Oxford’s Nuffield Department of Population Health. “This result should change medical practice worldwide.”

Launched in March, the RECOVERY trial is designed to test a range of potential treatments for COVID-19, including hydroxycholoroquine, the HIV regimen lopinavir-ritonavir, the steroid dexamethasone, the antibiotic azithromycin, the injectable anti-inflammatory tocilizumab and convalescent blood plasma.

Convalescent plasma is collected from donors who have recovered from COVID-19, and is believed to contain antibodies against SARS-CoV-2 virus.

To date, more than 11,000 patients from 175 National Health Service hospitals in Britain have been enrolled. The independent Data Monitoring Committee reviewed the emerging data every two weeks to determine if there is evidence that would be strong enough to affect national and global treatment of COVID-19.

On Thursday, the committee recommended that the chief investigators review the unblinded data on the hydroxychloroquine arm of the trial, which compared 1,542 patients treated with hydroxychloroquine with 3,132 patients who received usual care.

The investigators found that there was no significant difference in 28-day mortality between those treated with hydroxychloroquine — 25.7 percent — and those who received usual care — 23.5 percent. The drug did not have any “beneficial effects on hospital stay duration or other outcomes,” the researchers said.

Based on these findings, the researchers said in a statement, “we have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect.”



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FDA issues emergency authorization for first at-home COVID-19 test

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Nov. 18 (UPI) — The U.S. Food and Drug Administration has issued an emergency authorization for the first rapid coronavirus test that can be administered at home.

The agency announced the authorization for the all-in-one test kit late Tuesday in response to a request by Kelly Lewis Brezoczky of Lucira Health, the California-based company that developed the test.

In a letter to Brezoczky, the FDA said the test meets the criteria for an emergency use authorization as there are no available alternatives and the product’s benefits outweigh its known and potential risks.

The test has been authorized for use with samples collected from the nasal cavity of those age 14 years and older whose doctors suspect they have been infected with the coronavirus. Use in doctor’s offices, hospitals, urgent care centers and emergency rooms has been approved for all ages.

While there have been other products approved for collecting samples at home, the Lucira product is the first to be fully self-administered and to provide results without a physician’s assistance.

The company’s website said the test is intended to cost under $50 and is designed to provide results within 30 minutes.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

FDA Commissioner Stephen M. Hahn said the development of a COVID-19 test that can be administered outside a healthcare setting has been a major priority for the FDA, and now that there is one more people who suspect that they may have been infected with the virus can take immediate action to protect themselves and their community.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” he said.

The FDA approval was issued as the nation deals with a growing widespread outbreak. According to data collected by Johns Hopkins University, the United States has recorded more than 150,000 case a day in five of the last six days.

The United States has reported more than 11.3 million infections and nearly 250,000 deaths, making it by far the sickest country to the pandemic.



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Antidepressant might help prevent severe COVID-19

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The antidepressant drug fluvoxamine — best known by the brand name Luvox — may help prevent serious illness in COVID-19 patients who aren’t yet hospitalized, a new study finds.

The study included 152 patients infected with mild-to-moderate COVID-19. Of those, 80 took fluvoxamine and 72 took a placebo for 15 days.

By the end of that time, none of the patients who took the drug had seen their infection progress to serious illness, compared with six (8.3%) of the patients who took the placebo, according to researchers at Washington University School of Medicine in St. Louis.

“The patients who took fluvoxamine did not develop serious breathing difficulties or require hospitalization for problems with lung function,” said first author Dr. Eric Lenze, professor of psychiatry.

“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital. Our study suggests fluvoxamine may help fill that niche,” Lenze noted in a university news release.

Fluvoxamine — widely used to treat depression, obsessive-compulsive disorder and social anxiety disorder — is a type of drug called a selective serotonin-reuptake inhibitor (SSRI). This class of drugs also includes medicines such as Prozac, Zoloft and Celexa.

But unlike other SSRIs, fluvoxamine has a strong interaction with a protein called the sigma-1 receptor, which helps regulate the body’s inflammatory response.

“There are several ways this drug might work to help COVID-19 patients, but we think it most likely may be interacting with the sigma-1 receptor to reduce the production of inflammatory molecules,” explained study senior author Dr. Angela Reiersen, associate professor of psychiatry.

“Past research has demonstrated that fluvoxamine can reduce inflammation in animal models of sepsis, and it may be doing something similar in our patients,” she said in the release.

By reducing inflammation, fluvoxamine may prevent a hyperactive immune response in COVID-19 patients. That, in turn, may decrease their risk of serious illness and death, Reiersen said.

“Our goal is to help patients who are initially well enough to be at home and to prevent them from getting sick enough to be hospitalized,” Dr. Caline Mattar, assistant professor of medicine in the Division of Infectious Diseases, said in the release. “What we’ve seen so far suggests that fluvoxamine may be an important tool in achieving that goal.”

Dr. Amesh Adalja is a senior scholar at the Johns Hopkins Center for Health Security in Baltimore. He wasn’t involved in the study, but said the research is “notable not only because of its positive outcome — we desperately need a medication that keeps COVID patients out of the hospital — but also because of the manner in which it was conducted.”

But Adalja stressed that a larger trial is needed “to see if the promising findings hold up.”

The researchers said they plan to begin such a study in the next few weeks and it will include patients from across the United States.

The preliminary study was published online Nov. 12 in the Journal of the American Medical Association.

More information

For more on COVID-19, go to the U.S. Centers for Disease Control and Prevention.

SOURCES: Amesh Adalja, M.D., senior scholar, Johns Hopkins Center for Health Security, Baltimore; Washington University in St. Louis, news release, Nov. 12, 2020

Copyright 2020 HealthDay. All rights reserved.



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Survey: 40% in U.S. planning large gatherings for holidays despite COVID-19 warnings

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Nov. 12 (UPI) — Nearly 40% of U.S. residents plan to participate in gatherings of 10 or more people this holiday season despite concerns over the spread of COVID-19, according to the findings of a survey released Thursday by Ohio State University.

In addition, one-third of respondents said they wouldn’t ask attendees at holiday parties with family or friends to wear masks, and just over 25% indicated that they wouldn’t practice social distancing, the data showed.

“We’re going to look back at what happened during this holiday season and ask ourselves, ‘Were we part of the solution or were we part of the problem?'” Dr. Iahn Gonsenhauser, part of the team that conducted the survey, said in a statement.

“When you’re gathered together around the table, engaged in conversation, sitting less than 6 feet apart with your masks down, even in a small group, that’s when the spread of this virus can really happen,” said Gonsenhauser, chief quality and patient safety officer at Ohio State University Wexner Medical Center.

Researchers at Ohio State surveyed more than 2,000 U.S. residents on their holiday plans in the context of the COVID-19 pandemic.

As of Thursday afternoon, nearly 10.5 million people nationally have been sickened by the virus, and more than 240,000 have died, according to figures from Johns Hopkins University.

In recent weeks, federal, state and local public health officials have advised against traveling or partaking in large social gatherings as the holiday season approaches to limit the risk of spreading the new coronavirus to vulnerable loved ones.

At the very least, they’ve asked that gatherings not happen without wearing a mask and practicing social distancing, or staying 6 feet apart.

Those at risk for severe COVID-19 include the elderly, as well as those with diabetes, heart disease and high blood pressure, all of which are common across the United States, according to the Centers for Disease Control and Prevention.

Still, 38% of respondents to the Ohio State survey indicated they would host or attend a gathering with 10 or more people during the holidays and 33% would not ask others to wear masks, the researchers said.

However, 73% of respondents said they would practice social distancing during the holidays and 79% suggested that they would celebrate or gather only with people with whom they live, the data showed.

Just over 80% indicated that they would ask family and friends invited to events not to come if they had symptoms of COVID-19.

“If you have someone in your household who’s high risk and you’re in a low incidence area, you’re going to want to think twice about having a celebration where people are coming from an area where there’s a lot of virus in the community,” Gonsenhauser said.



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