In a recent study published in the Journal of American Medical Association, researchers investigate the effects of high-dose fluvoxamine among patients with mild-to-moderate coronavirus disease 2019 (COVID-19).
Multiple clinical trials have investigated approved drugs as repurposed therapies for patients with mild-to-moderate COVID-19. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) proposed to reduce inflammatory responses and prevent severe disease progression. Although one study suggested that fluvoxamine decreased hospitalization rates in adult patients, this evidence was insufficient to recommend its use.
Taking 100 mg of fluvoxamine two to three times each day has been shown to reduce emergency room visits and hospitalization; however, tolerability has been a limitation. To overcome this challenge, a lower dose of 50 mg has been shown to improve tolerability; however, this dose was ineffective in two clinical trials.
The accelerating COVID-19 therapeutic interventions and vaccines (ACTIV-6) platform clinical trial evaluates repurposed drugs. In an ACTIV-6 trial involving over 1,300 adult COVID-19 patients randomized to 50 mg fluvoxamine or placebo, there were no differences in the time to sustained recovery between groups.
The lack of effectiveness of fluvoxamine in this trial was likely due to the inadequate dose. Nevertheless, the conflicting findings from large trials warrant validation of the therapeutic benefits of fluvoxamine at a higher dose.
In the present study, researchers evaluate the effects of a higher dose of fluvoxamine in mild-to-moderate COVID-19 patients. Eligible subjects were aged 30 or older with a positive antigen or polymerase chain reaction (PCR) test result. Furthermore, each study participant reported experiencing at least two of the following symptoms including sore throat, loss of sense of smell/taste, body aches, diarrhea, vomiting, cough, nausea, dyspnea, fatigue, nasal symptoms, fever, and chills.
Participants were recruited from August 25, 2022, to January 20, 2023. Subjects were excluded if they participated in other COVID-19 trials, were pregnant, breastfeeding, recently/currently hospitalized for COVID-19, using fluvoxamine, or had bipolar disorder or contraindications/allergy to fluvoxamine.
Participants were instructed to consume two 50 mg tablets of fluvoxamine or placebo on the first day and 100 mg tablets of fluvoxamine or placebo twice a day for the next 12 days. Medical history, demographic information, race/ethnicity, COVID-19 symptoms, and use of other medications were self-reported by the participants.
The primary outcome was the time to sustained recovery, which was defined as the time from intervention to the third of three consecutive days without symptoms. Secondary outcomes included time to hospitalization/death, time to death, COVID-19 clinical progression scale scores, average time spent unwell, and a composite of emergency room/urgent care visits, hospitalization, or death.
The study randomized 1,175 participants to receive fluvoxamine or placebo. About 66% of the study participants were female and 72.7% were White. Hypertension and obesity were the most common comorbidities.
Over 75% of participants received at least two doses of a COVID-19 vaccine. About 10% of participants reported no symptoms at the time of study drug receipt, whereas the remainder reported mild/moderate symptoms.
There were no differences in time to sustained recovery between groups, with a median of 10 days. No deaths occurred in either group. Three participants were hospitalized, including one fluvoxamine recipient.
Fourteen fluvoxamine recipients and 21 placebo recipients reported emergency room/urgent care visits or hospital admission. The clinical progression scale was simplified into a self-evaluation of home activity levels, as hospitalizations and deaths were rare.
Over 95% of study participants had no activity limitations by day seven. Moreover, the average time spent unwell was similar between groups.
Six individuals experienced serious adverse events. More specifically, two fluvoxamine recipients reported Guillain-Barre syndrome, pneumonia, and aggravated asthma, whereas four placebo recipients reported perforated intestinal diverticulitis, partial bowel obstruction, ruptured appendix, and diabetic foot ulcer.
The researchers did not observe a meaningful separation between groups when stratified by symptom severity at baseline and timing of therapy relative to symptom onset. Exploratory analyses suggested that participants who received fluvoxamine more quickly following the onset of their symptoms had poorer symptom resolution than placebo recipients. In contrast, those who received fluvoxamine treatment around seven days post-symptom onset had better resolution than placebo participants.
The study findings indicate that treating mild-to-moderate COVID-19 patients with a higher dose of fluvoxamine did not improve the primary outcome relative to placebo recipients. Notably, the secondary composite outcome of healthcare utilization or death suggested nearly 33% fewer events among fluvoxamine recipients; however, this effect did not meet decision-making thresholds.
The threat of respiratory viruses is causing anxiety among US adults this fall, a third of whom say they worry that they or a family member will catch COVID-19, flu, or respiratory syncytial virus (RSV) in the next 3 months, finds a new survey from the Annenberg Public Policy Center (APPC) of the University of Pennsylvania.
Researchers fielded the Annenberg Science and Public Health Knowledge survey to 1,559 adults from October 5 to 12, 2023. It was the 13thsurvey of the nationally representative panel since April 2021 and has a margin of sampling error of plus or minus 3.4 percentage points at the 95% confidence level.
When asked which virus is most likely to cause severe illness, 22% of respondents said COVID-19, 13% said RSV, 7% said flu, 41% said they are equally likely to cause severe disease, and 16% said they were unsure.
Key current survey results compared with previous waves:
Because getting a flu shot yearly not only helps to protect us from serious infection but also predicts our acceptance of other CDC-recommended vaccines, the drop in reported flu vaccination we see reflected in our panel is worrisome.
Less than 10% of US interventional COVID-19 trials in the first 3 years of the pandemic included children, and only 1.6% enrolled them exclusively, despite this age-group accounting for 18% of infections, Harvard and Boston Children's Hospital researchers report today in JAMA Health Forum.
The team identified all COVID-19 trials registered on ClinicalTrials.gov from January 2020 to December 2022. They noted that children have been underrepresented in clinical research owing to ethical, logistical, and financial reasons.
"The emergence of the COVID-19 pandemic triggered a rapid investment in research activities to identify prevention measures and develop therapeutic interventions," they wrote. "While children were eventually determined to have a milder disease course compared with adults, studying children was critical to elucidate transmission patterns and identify treatments for pediatric patients with severe disease, including multisystem inflammatory syndrome."
Of 1,216 trials, 20 (1.6%) enrolled only children, while 120 (9.9%) included only children or both children and adults, and 1,096 (90.1%) enrolled only adults. The percentage of trials enrolling children rose from 45 (7.1%) in 2020 to 27 (15.7%) in 2022.
Relative to adult-only studies, those including children were less likely to focus on COVID-19 treatments (48.3% vs 69.8%) or on testing medications, biologics, or devices (48.3% vs 64.6%). Rather, they tended to focus on prevention (47.5% vs 23.0%), behavior (25.8% vs 16.8%), and vaccines (14.2% vs 5.8%).
Recent methodologic advancements in pediatric extrapolation, pharmacokinetic and pharmacodynamic modeling, and adaptive trial designs, can be applied to support earlier initiation.
Fewer drug studies enrolling children were phase 1 or 2 (42.0% vs 70.4%) or were randomized (69.2% vs 79.3%). Most studies including children (71 [59.2%]) focused on those older than 2 years, with only 49 (40.9%) open to younger kids.
The researchers said that low rates of inclusion of children probably reflect the tradition of delaying interventional trials in children until after adults have been studied.
But more attention is now being paid to the advantages of early pediatric trials. "Recent methodologic advancements in pediatric extrapolation, pharmacokinetic and pharmacodynamic modeling, and adaptive trial designs, can be applied to support earlier initiation," they wrote.
The FDA recently extended the shelf life of 20 different tests you could receive in the mail.
ALBUQUERQUE, N.M. July 6 was a date that had Linda Wood doing a double take.
My first reaction was what am I going to do? I guess I have to throw these away, said Linda Wood, an Albuquerque resident.
It was the expiration date on the COVID-19 test she got from the federal government in October.
Which was confusing to me, because I knew I had ordered it after that, said Wood.
When she couldnt get into her doctors office and learned an urgent care Rapid Test could cost her $70 she called the company on the box.
They said that theyre extending it for nine months, Wood said.
The FDA recently extended the shelf life of 20 different tests you could receive in the mail.
What happened, in order to get these tests out quickly, they didnt have a year or two years to kind of test and see whether they still worked. So they kind of short-dated them, put six months on, that allowed us to get tests in peoples hands quickly, said NMDOH Chief Medical Officer Mirando Durham.
Behind the scenes, they were working on a more accurate expiration timeline.
Durham says at the very least you can use an expired test as a start while you wait for a new one.
Officially, we shouldnt be using expired tests. But if its been well-kept and preserved, its probably OK as a starter to check, said Durham. If its been sitting in your car and getting to 100 degrees in the summer, and you know, down to freezing in the winter, like that test isnt going to be as reliable, whether its expired or not.
Durham says an expired test could produce a false negative or positive in some cases.
Meanwhile, Wood adds this to her ever-growing list of uncertainty surrounding COVID-19:
They should have really broadcasted that you can continue to use these for nine months. They really should have made a bigger point about that. Because I didnt know, and I dont know that many people do, said Wood.
Department of Health leaders are reminding New Mexicans its the perfect time to get a COVID-19 booster.
They say across the board vaccination numbers for the newest booster are low, while flu and RSV cases are starting to rise.
For a list of extended expiration date test brands, click here.
LOS ANGELES (KABC) -- Dozens of current and former city of Los Angeles workers are seeking damages in a lawsuit alleging that the FDA's emergency use authorization for COVID-19 vaccines allows individuals to refuse the shot without facing penalties from employers.
The group of plaintiffs, who held a news conference Tuesday on the steps of City Hall, say they were terminated from their jobs when they refused to get the COVID-19 vaccine.
"In the city of Los Angeles, our workers worked and our workers kept the city working," said attorney Jennifer Kennedy.
City employees were mandated to be vaccinated by Dec. 18, 2021.
There are more than 50 plaintiffs in this lawsuit, including Michael McMahon, who served as a Los Angeles police officer for 14 years.
"I refused to wear a mask, I refused to test or take the EUA shots. I was suspended without pay," McMahon said.
Michael Parks worked for the LAPD for 16 years. According to Parks, he was about to be promoted but instead was terminated after he decided not to get the vaccine.
"I thought that what they were doing was wrong. I thought that people should have the ability to make their own choice as far as what they put in their body," Parks said.
On the fence about the new COVID shot? Survey reveals what it will take to persuade Americans
According to the Centers for Disease Control and Prevention, COVID-19 vaccines are safe and effective. Hundreds of millions of people in the United States have received vaccines.
ABC7 reached out to Mayor Karen Bass' office for a statement about the lawsuit but did not hear back.
New research suggests drinking coffee can reduce COVID-19 infection.
Daily coffee drinking can reduce the infection risk of SARS-CoV-2, the virus that causes COVID-19, according to new research from Taiwan.
After conducting in vitro lab testing of human cells, as well as a human trial involving 64 participants given a SARS-CoV-2 pseudovirus, the research team concluded that drinking coffee every day might be a useful dietary tool in preventing infection in individuals. It may also reduce the severity of COVID-19 infections, the researchers said.
The results were consistent for different coffee types ground and instant, caffeinated and decaffeinated as well as for the most common recent COVID-19 variants, such as Delta and Omicron.
Interestingly, no matter what kind of coffee or adding additional intergrading (sugar or milk), it has the capability to reduce SARS-CoV-2 entering into host cells, the researchers wrote. Our research supported drinking coffee is related to reducing COVID-19 infection, which is consistent with the opinion of meta-analyses that reported coffee consumption related to a lower COVID-19 positive probability.
The full study was published last week in the journalCell & Bioscience, an open-access, peer-reviewed journal, and the official journal of the Society of Chinese Bioscientists in America. The journal is part of the Springer academic publishing network. Lead authorsMien-Chie Hung, Chen-Shiou Wu, Yi-Chuan Li and Shin-Lei Peng are all affiliated with the China Medical University in Taichung, Taiwan. None of the authors declared any affiliations or funding associations with the coffee sector.
The study builds upon a 2021 study from researchers in the United States that found that people who drank one or more cups of coffee per day were at 10% lower risk of developing COVID-19 than people who drank less than one cup. Another study involving a human trial of adults aged 75-90 in Spain found that the severity of COVID-19 infections was significantly reduced among coffee drinkers.
Additional research has shown that immune-boosting factors such as exercise and a healthy diet including consuming polyphenols, naturally occurring plant chemical compounds that are abundant in coffee might lower the risks of COVID-19 infection and severity.
The research team in Taiwan set out to discover the potential human cellular mechanisms that can explain such results.
Our results demonstrated that coffee, a beverage readily available, can be a new strategy to reduce SARS-CoV-2 infection via blocking spike protein ACE2 interaction, inhibiting TMPRSS2 and CTSL activity, and diminishing the protein level of TMPRSS2 and ACE2, respectively, they wrote.
The authors further suggest that because governments have lifted many of the individual safety requirements regarding the spread of SARS-CoV-2 such as masking or social distancing that prevention measures such as diet should be explored further.
Regular dietary behavior to prevent SARS-CoV-2 infection becomes an interesting issue, they wrote. In particular, coffee is one of the most common beverages people consume. The results from the current study may provide the scientific basis for the public to prevent from infection of SARS-CoV-2 by drinking coffee.
Does your coffee business have news to share? Let DCNs editors know here.
Nick Brown Nick Brown is the editor of Daily Coffee News by Roast Magazine.
Tags: Chen-Shiou Wu, China Medical University, COVID-19, health, Mien-Chie Hung, Polyphenol, polyphenols, research, SARS-CoV-2, science, Shin-Lei Peng, Taichung, Taiwan, Yi-Chuan Li
Early in the COVID-19 outbreak, some people dismissed the new respiratory virus as like the flu. It isnt, of course; but for the purposes of vaccination, it would be nice if people acted that way.
About 51% of Hawaiis population got the flu vaccine during the 2022-23 season, according to the Kaiser Family Foundation. As of last week, only about 7.6% have received the d COVID vaccine, the one that targets the latest omicron variant, according to the Hawaii Department of Health (DOH).
DOH and the U.S. Centers for Disease Control and Prevention recommend the COVID shot for anyone 6 months or older, unless health conditions prevent it. Good idea, with the holidays now upon us.
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Wednesday 22 November 2023 22:41, UK
The birth of a critically endangered eastern black rhino has been dubbed "quite unusual" by experts at Chester Zoo.
The female calf - who remains without a name - was born on 12 November, and after a 15-month pregnancy, keepers at the zoo had been eagerly awaiting the new arrival.
But they were caught unawares when the birth happened right in front of their eyes, with the entire event caught on camera.
"It's quite unusual for a rhino to give birth in daylight hours," Emma Evison, rhino team manager, said.
"To be able to witness the calf safely entering the world, in front of our very own eyes, was just the most incredible privilege."
She said the calf is "very inquisitive and full of energy" and is "inseparable" with her mother Zuri.
"Little one is feeding regularly and already gaining in size and weight," Ms Evison said.
The eastern black rhino is classed as critically endangered by the International Union for the Conservation of Nature Red List, meaning it is facing an extremely high risk of extinction in the wild.
There are less than 600 found across Kenya, Tanzania and Rwanda, according to Chester Zoo.
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Around 95% of rhinos in Africa have been wiped out by poaching, due to the demand for rhino horn, which stems from the traditional Asian medicine market, the zoo said.
Read more: Bats use penises in bizarre way during sex Mysterious respiratory virus spreading among dogs in US First grey seal pups of the winter born in England
European conservation zoos hope that with projects like the endangered species breeding programme, the numbers of rhino in the wild will gradually increase.
There has already been some success with one group of zoo-bred rhinos re-located to a protected National Park in Africa in 2019, the zoo said.
"Our efforts to protect this magnificent species extend far beyond the zoo's boundaries and, while it's incredibly positive news that conservation efforts across Africa have led to a small recovery in rhino numbers, giving some much-needed breathing space, we know there's still lots of work to be done," Mike Jordan, director of animals and plants at Chester Zoo said.
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STATUS CODE: 500
COVID-19 home test kits are pictured in a store window during the coronavirus disease (COVID-19) pandemic in the Manhattan borough of New York City, New York, U.S., January 19, 2022.
Carlo Allegri | Reuters
The Biden administration on Monday said it is offering another round of free at-home Covid tests to U.S. households ahead of the holiday season, when more people gather indoors and the virus typically spreads at higher levels.
Starting Monday, Americans can useCOVIDtests.govto request four free tests per household. Those who have not ordered any tests this fall can now place two orders for a total of eight tests, according to the website.
The administration in September allowed people to request an initial round of four free tests through the site, resuming a federal program that temporarily shut down during a political fight over Covid funding.
At-home tests are a critical tool to protect against the virus, especially now that lab PCR tests the traditional method of detecting Covid have become more expensive and less accessible since the government ended the public health emergency in May.
But demand for tests, along with Covid vaccines and treatments, has plummeted over the last year as cases and public concern about the virus dwindled from earlier in the pandemic.
Only a small share of Americans appear to be worried about Covid disrupting their holiday plans this fall and winter.
About 3 in 10 Americans said they are concerned they will get seriously sick from Covid or will spread the virus to people close to them over the holidays, according to a poll released Friday by health policy research organization KFF.
Less than half were concerned about the potential for another Covid surge during the winter, which has occurred in previous years of the pandemic, the poll said.
Still, signs of a winter Covid wave are emerging.
More than 16,200 Americans were hospitalized in the week ending Nov. 11, according to the latest data from the Centers for Disease Control and Prevention.That marks an 8.6% increase from the previous week.
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