Category: Corona Virus Vaccine

The results of the present study showed that the intensity of exercise, duration, and the number of sessions per week significantly decreased during the COVID-19 outbreak compared to before. While these results were not unexpected, the fear of infection may have limited various activities, including social activities and exercise, and may have even led to the closure of clubs after the outbreak. Furthermore, these changes in lifestyle, combined with not having fun leisure time, led to an increase in stress and anxiety levels in society.

However, the closure of physical activities has been linked to many diseases, worsening obesity and motor poverty16. Health researchers therefore recommend modifying workout routines to strengthen the immune system16, 17. Due to restrictions and closures of sports clubs to prevent the spread of coronavirus, attending clubs has become limited18, 19. To prevent the consequences of a sedentary lifestyle, such as obesity, home exercise and increased physical activities such as walking may be beneficial16, 20.

Furthermore, the results of the present study indicate that moderate levels of exercise activity significantly reduce negative mood states caused by the fear of COVID-19 and increase positive mood states. Being sedentary resulted in a significant increase in negative mood states and a significant decrease in positive mood states. In this study, a high level of PA was not only significantly related to increased positive mood states but also to increased negative mood states.

In general, PA is one of the most important contributors to physical and mental health. Exercise can improve the body's ability to fight infection by strengthening the immune system18. However, according to some study results, intense and competitive exercise may not be suitable during these conditions and can reduce the body's immune response, leading to a higher risk of COVID-19 infection21, 22. Most studies have highlighted the importance of avoiding a sedentary lifestyle, which is very common, especially among young people who spend excessive amounts of time on social media and networks. In addition to improving immune function and capacity, PA can help reduce anxiety and stress, improve mood, and manage underlying diseases such as diabetes, hypertension, and cardiovascular disease. Healthy adults should engage in at least 30 minutes of moderate-intensity exercise per day. The findings of the study suggest that PA levels were significantly lower during quarantine, which in turn had a negative impact on mood state among the Kermanshah population. This low level of PA is not surprising given the limitations on movement and exercise during quarantine periods. Inactivity may lead to physical and mental health issues, which is supported by the finding that mood state was negatively impacted by low PA levels.

The negative impact of low PA levels on mood state was seen in the study, with a significant negative correlation between PA levels and mood state. Participants who engaged in PA had a better mood state than those who did not. This finding is supported by previous research, which has shown that exercise can lead to increased feelings of well-being and positive mood.

The findings of this study have important implications for public health policy during quarantine periods. It is crucial to promote PA during quarantine to mitigate the negative impact on mental and physical health. This can include providing resources and guidance for home workout routines, as well as encouraging outdoor PA while adhering to social distancing measures.

Previous studies have shown that physical inactivity has become a significant public health concern during the COVID-19 pandemic23, 24. Several studies have reported a decrease in PA levels in both healthy individuals and people with chronic diseases during quarantine measures. For instance, a systematic review and meta-analysis showed that people who were under lockdown during the pandemic had significantly decreased PA levels than before the pandemic25. Similarly, Hansen et al. (2022) found evidence that PA levels decreased substantially during COVID-19 quarantine among the general population26. Furthermore, research has also shown that low PA levels during COVID-19 quarantine measures are associated with negative mood states. Maugeri et al. (2020) demonstrated that inactivity levels during COVID-19 confinement were positively correlated with depression and anxiety symptom severity27. Similarly, Aghababa et al. (2021) found that a lower level of PA was associated with increased levels of stress, anxiety, and depression among Iranian individuals during quarantine28.

The COVID-19 pandemic and the subsequent quarantine measures have led to increased periods of inactivity for many individuals, which can have profound effects on hormone levels in the body. Hormones play a vital role in various physiological processes, including mood regulation, stress response, metabolism, and immune function. Reduced physical activity and changes in lifestyle during quarantine can disrupt hormone levels, potentially impacting mental and physical health. During periods of inactivity and quarantine, stress hormones like cortisol may be affected. Chronic stress and reduced physical activity can lead to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in abnormal cortisol levels. High cortisol levels, associated with chronic stress, can contribute to mood disorders, impaired immune function, and metabolic disturbances. A study by Wilkialis et al. (2021) found increased stress and cortisol levels among individuals in quarantine, suggesting a potential link between inactivity, quarantine, and dysregulated stress hormone levels29. Also, inactivity and reduced physical activity during quarantine can also influence metabolic hormones such as insulin and leptin. Prolonged periods of inactivity and sedentary behavior can exacerbate insulin resistance, increasing the risk of metabolic disorders like type 2 diabetes. Sallis et al. (2020) conducted a study that revealed reduced physical activity during quarantine was associated with increased insulin resistance and higher levels of leptin, highlighting the negative effects of inactivity on metabolic hormone levels30. Moreover, Physical activity is known to stimulate the release of mood-regulating hormones like serotonin, dopamine, and endorphins, promoting well-being and reducing symptoms of depression and anxiety. Therefore, reduced physical activity during quarantine may result in imbalances in these mood-regulating hormones. Lesser et al. (2020) found a significant increase in depressive symptoms among individuals with lower levels of physical activity during quarantine, suggesting a potential link between reduced physical activity, altered mood-regulating hormone levels, and negative mental health outcomes9. However, the COVID-19 pandemic and the associated periods of inactivity and quarantine can have significant effects on hormone levels in the body. Disruptions in stress hormones, metabolic hormones, and mood-regulating hormones are observed during these periods, potentially impacting mental and physical health. It is crucial to recognize the potential impact of inactivity and quarantine on hormone levels and take steps to mitigate these effects through regular physical activity and maintaining a healthy lifestyle.

Overall, these studies provide further support for the current study's findings that low PA levels during COVID-19 quarantine measure correlate with negative mood states. It suggests that prioritizing PA during quarantine measures may have potential benefits for promoting mental health and well-being during this pandemic.

The strengths of a study that focuses on the relationship between exercise and mood states during the COVID-19 pandemic . Firstly, the study provides a comprehensive analysis by considering factors such as exercise intensity, duration, frequency, closure of clubs, and increased stress and anxiety levels. This comprehensive data allows for a thorough understanding of the relationship between exercise and mood during quarantine. Secondly, the study's findings align with previous research, which enhances its credibility. Additionally, the study offers clear recommendations for public health policy during quarantine, emphasizing the importance of promoting physical activity to mitigate the negative impact on mental and physical health. Furthermore, the study mentions a large sample size, which enhances the generalizability of the findings. Lastly, the study acknowledges the limitations of intense and competitive exercise during the pandemic, demonstrating a balanced perspective. Overall, these strengths contribute to the study's credibility, relevance, and potential impact on public health policies during quarantine.

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Negative mood state in Kermanshah population during COVID-19 ... - Nature.com

Leading the team is Sarang Yoon, DO, MOH, a professor with the University of Utah and Rocky Mountain Center for Occupational and Environmental Health who has significant experience researching COVID-19. She said this study, called BEEHIVE (Booster Epidemiological Evaluation of Health, Illness, and Vaccine Efficacy), is likely to yield valuable knowledge that can aid in the development of more effective vaccines. Our team is excited about launching this project and looking forward to gaining valuable insight into COVID-19 boosters, she said. None of it is possible without our participants, so were grateful for everyone who helps out with this effort. I hope people know that their participation truly matters and helps us perform research that, at the end of the day, will hopefully help people. People who join the study can earn up to $550 in compensation based on the length of their participation. Receiving a COVID-19 booster vaccine is not a requirement, but participants may choose to get one as part of the study. Participation entails completing online surveys at the beginning, middle, and end of the project, as well as reporting symptoms of illness through online surveys when sick.

The BEEHIVE project is the latest of four large-scale vaccine studies Yoon and her team have conducted in the last three years. Two of the previous studies were focused on COVID-19, and another examined the efficacy of influenza vaccines. Those studies resulted in a number of peer-reviewed publications, including two in The New England Journal of Medicine, the most prestigious medical journal in the world. Anyone interested in participating in the study can learn more and sign up at beehivestudy.com or by contacting the research team at beehivestudy@utah.edu or 801-203-0320.

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Researchers Launch COVID-19 Vaccine Research Project, Seek ... - University of Utah Health Care

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A Comparison of the Epidemiological Characteristics Between ... - Cureus

LINCOLN The percentage of Nebraska students who tested proficient in English language arts and math appears to be rebounding after a drop during the COVID-19 pandemic.

According to data from the Nebraska Department of Education, released Wednesday, the percentage of students in grades 3-8 who tested proficient in English language arts or mathrose by double digits compared to last year.

In 2022, 47% of students were proficient across statewide tests in English language arts, while 46% of students were proficient in math. For the most recent school year, those proficient in English language arts rose to 58% and students proficient in math rose to 61%.

Science proficiency scores, which are a baseline for tests administered to fifth and eighth graders, also showed improvement, rising from 66% last year to 70% for the 2022-23 school year.

The results surpass pre-pandemic proficiency scores in all three areas.

While Nebraskas statewide assessments showed student and school growth and improvement, it also showcased the need for focused efforts in several areas, Nebraska Education Commissioner Brian Maher said at a Wednesday news conference.

High schoolers were 46% proficient in English language arts, 42% proficient in math and 49% proficient in science, based on ACT scores taken largely by juniors. English scores held steady, while proficiency in math dropped 2% and science improved 1%.

New English language arts standards were approved in September 2021, Maher said, and were tested for the first time in 2023. He said this leads to new baseline scores and better reflects student achievement when compared to student peers across the state and nationwide.

Maher said that he is pleased by the results and that he hopes to build on the momentum and really help teachers teach.

Because, as everybody truly knows, thats where the magic happens in education, he added.

Areas in need of improvement, Maher noted, include:

We need to continue to work together as a state to provide the best possible opportunities for every student to succeed and be prepared for life after school, Maher said.

Maher said Nebraska is working to address these gaps through new collection models for learning disabilities, including dyslexia. State lawmakers passed related legislation as well this year.

The commissioner also noted that the Education Department is investing $2 million in sending age-appropriate books to families and child care providers statewide.

State and federal law requires the department to classify schools to signal which ones may need specific support, with a majority of schools classified as excellent or great.

Nebraskas Accountability for a Quality Education System, Today and Tomorrow model measures schools and districts on various factors, including proficiency scores in English language arts and math.

The most recent classifications break down into:

Six school districts are classified as being in need of additional support: Elba Public Schools, Santee Community Schools, Harvard Public Schools, Omaha Public Schools, Walthill Public Schools and Winnebago Public Schools.

The departments Office of Coordinated School and District Support will reach out to help, according to Derek Ippensen, assistant administrator and director of accountability in the office.

Ippensen said additional support could be through forming connections with the Education Department, strengthening school or familial relationships or providing high-quality instructional materials or formative and interim assessments.

Maher, who is in his first year as commissioner, said the Department of Education will prioritize working with schools, state lawmakers and all those concerned about Nebraskas educational system to address education but also uplift student subgroups.

To sum all that up, weve got a lot of work to do, Maher said. Work that I think is rewarding and fascinating and certainly instrumental for the moving forward of the state of Nebraska.

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Nebraska student test scores appear to rebound after COVID-19 ... - Nebraska Examiner

Above all else, we are committed to the care and improvement of human life. Preventing the spread of viruses like the flu, respiratory syncytial virus (RSV) and COVID-19 is a high priority for HCA Healthcare, for the safety of our patients, those who care for them and the communities where we live and serve. As we approach the busy holiday season, the spread of these viruses is expected to grow which may leave you with questions about these infectious diseases.

HCA Healthcares chief epidemiologist, Dr. Kenneth Sands, focuses on keeping patients and our colleagues safe from infection across HCA Healthcares 183 hospitals and more than 2,300 sites of care. We sat down with Dr. Sands to discuss the triple threat posed by the seasonal flu, RSV and COVID-19, and what people can do to stay healthy in the coming months.

Dr. Sands: Flu season typically starts each October and could end as late as May. While we are starting to see flu activity increase, we dont typically see cases peak until the period of time between December and February.

Dr. Sands: There is still time to get protection from the flu. It can take up to two weeks after vaccination for antibodies that protect against the flu to develop in your body meaning if you get vaccinated this week, you will have a layer of protection for your Christmas, Hanukkah, Kwanzaa and New Years celebrations.

I would urge everyone to consider getting the flu vaccine. It is safe and effective. Each year the flu vaccine is customized to address the most anticipated strains among the population so it can best protect people from becoming very sick if you do get infected.

The CDC shares current recommendations for who should receive the flu vaccine.

Dr. Sands: Respiratory syncytial virus, or RSV, is a common respiratory virus that in most cases causes mild, cold-like symptoms. However, RSV can be serious for infants and older adults. Right now, we are seeing increases in RSV activity indicating the 2023-2024 RSV season is now in full swing, particularly in the southern U.S. where rates of RSV infection are highest.

Dr. Sands: This year for the first time, there are vaccines that can help prevent severe illness from RSV. Two different manufacturers now make a vaccine that can be given to those who are at least 60 years old as they are at a greater risk for complications from RSV, especially if they have some underlying health conditions. The recommendation from the Centers for Disease Control and Prevention (CDC) is for these patients to discuss with their physician whether to receive the vaccine.

One of these vaccines is also approved for women who are 32-36 weeks pregnant, who will then pass on protection to their newborn child. Finally, there is now an antibody that acts as a passive vaccine that can be given directly to newborns. The CDC recommends that these two immunizations to protect newborns be administered during RSV season, which typically goes from September through January for most of the country.

For others who are less likely to develop RSV, everyday preventative action like staying home when you are sick, covering coughs and sneezes with a tissue, washing your hands and frequently cleaning touched surfaces like doorknobs and cell phones can reduce the likelihood of spreading RSV.

It is important that you feel comfortable with your decision, so I recommend having a conversation with your primary care provider to make the best decision for you and your family.

Dr. Sands: Viruses, including SARS-CoV-2, which causes COVID-19, can be expected to evolve in ways that allow them to infect more people successfully. One of the ways this might happen is that the virus becomes more contagious, infecting larger numbers of people but then weakening, making them less sick. That way, people can still circulate in society and the virus is more likely to continue spreading.

While there is some suggestion that COVID-19 is moving in this direction, it is difficult to define when something can be labeled endemic. We are now seeing the virus in circulation on a more permanent basis, with levels of activity that fluctuate within a smaller, more stable range. It is unlikely that we will completely eradicate COVID-19, so I would not be surprised to see it labeled as endemic in the future.

Dr. Sands: It is true that people can be infected with multiple viruses at the same time, and distinguishing between COVID-19 and the flu, for example, may pose challenges due to their similar symptoms. Fortunately, we have tests for both viruses that help us diagnose the right infection and treat it effectively.

Across HCA Healthcare, patients are very rarely identified as having two infections at the same time. As is the case with many viruses, vaccination is a critical aspect of prevention and lessening of severe symptoms of both diseases.

The CDC shares up-to-date clinical guidance on who is recommended to receive the COVID-19 vaccine and boosters.

Dr. Sands: HCA Healthcare is tracking the seasonal flu, RSV and COVID-19 together in a model that we put in place at the end of the last respiratory season, about 6 months before the CDC started reporting national data using a similar model.The system allows us to simultaneously monitor all three respiratory infections, providing a more comprehensive understanding of the overall impact on our facilities.

Dr. Sands: This holiday season, the best thing you can do for yourself and your family is to be up-to-date on your vaccines. Other best practices like social distancing, masking and good hygiene practices will be valuable tools in our collective arsenal as we continue to fight viruses and keep society healthy. I encourage everyone to monitor COVID-19, RSV and flu transmission levels in your state to help determine whether or not to wear a mask when gathering this holiday season. And, of course, stay home and isolate yourself if you are not feeling well. I know we cherish being around family this time of year, but it is not worth your loved ones health.

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HCA Healthcare's chief epidemiologist shares updates on flu, RSV ... - HCA Healthcare Today

DHAKA, Nov. 23 (Xinhua) -- The Asian Development Bank (ADB) has approved a loan package of 336.5 million U.S. dollars to establish domestic vaccine, therapeutics, and diagnostics manufacturing capacity in Bangladesh and strengthen its national regulator to ensure vaccine supply security.

"Our experience with the COVID-19 pandemic exposed challenges in accessing diagnostic testing kits, availability of vaccines, and pandemic preparedness. It highlighted the need to improve self-sufficiency and establish capacity to manufacture vaccines," said ADB principal health specialist Dinesh Arora in a statement on Wednesday.

"This project aims to build Bangladesh's resilience against future pandemics, improve vaccine supply security, and reduce the incidence and severity of vaccine-preventable diseases," said the specialist.

According to the Manila-based lender, the project will establish a comprehensive vaccine, therapeutic, and diagnostics manufacturing facility, along with a warehousing unit in Bangladesh's Essential Drugs Company Limited's existing location in Gopalganj, with a capacity to manufacture 58 million vials of vaccines per year.

An in-house research and development center will also be established to support the production of diagnostic kits and packaging of biosimilar therapeutics, it said.

ADB said the project is financed through its Asia Pacific Vaccine Access Facility, an initiative worth 9 billion dollars that was launched in December 2020, in order to provide rapid and equitable vaccine-related support to ADB's developing members.

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ADB approves loan to bolster COVID-19 vaccine production in ... - Xinhua

Three years after COVID-19 infection, 54% of adults in a Chinese cohort still had at least one symptom, most of them mild to moderate in severity, with higher rates of reinfection and pneumonia after the emergence of the Omicron variant, shows a study published yesterday in The Lancet Respiratory Medicine.

Researchers from China-Japan Friendship Hospital in Beijing led the study of 1,359 COVID-19 patients released from Jinyintan Hospital in Wuhan from January to May 2020. The patients completed three follow-up visits at 6 months, 1 year, and 2 years after illness onset. The study period spanned the predominance of wild-type SARS-CoV-2 and the emergence of all variants up to Omicron.

At 1 year, COVID-nave controls from two communities in Wuhan were recruited. At 2 years, the controls were matched in a 1:1 ratio with the COVID-19 patients who underwent lung function tests. At 3 years, all eligible COVID-19 survivors and controls matched at 2-year follow-up completed several face-to-face questionnaires, a 6-minute walking test (6MWT), and lab tests from February to April 2023.

Community controls and a sample of COVID-19 survivors stratified by illness severity during hospitalization underwent lung function tests. COVID-19 patients who underwent high-resolution computed tomography (CT) and had abnormal lung imaging results at 2 years were reevaluated.

Of the 1,359 COVID-19 survivors, 728 (54%) reported one or more mostly mild or moderate lingering symptoms at 3 years. After Omicron emerged in November 2021, relative to participants without long COVID, those with long COVID at 2 years had significantly higher rates of reinfection (76% vs67%) and pneumonia (5% vs2%).

Three months after Omicron infection, 126 of 204 COVID-19 survivors with long COVID at 2 years (62%) had new-onset or worsened symptoms, a significantly higher proportion than in the group without long COVID (41%) and controls (40%).

Although the organ function of survivors of COVID-19 recovered over time, those with severe long COVID symptoms, abnormal organ function, or limited mobility require urgent attention in future clinical practice and research.

The percentage wasn't significantly different between COVID-19 survivors without persistent symptoms and controls (41% vs39%). At 3 years, reinfection was a risk factor for shortness of breath (odds ratio [OR], 1.36), anxiety or depression (OR, 1.65), and EuroQol visual analog score (, 451) but not for less daily activity (OR, 0.72). The lung function of COVID-19 survivors at 3 years was comparable to that of controls.

"Although the organ function of survivors of COVID-19 recovered over time, those with severe long COVID symptoms, abnormal organ function, or limited mobility require urgent attention in future clinical practice and research," the study authors wrote.

In a related commentary, Ash Routen, PhD, and Kamlesh Khunti, MD, PhD, both of the University of Leicester, cautioned that the study data are from a single center in an ethnically homogenous population, with few critically ill COVID-19 survivors, and the lung function sample was small.

But they said the inclusion of matched community controls and the attempt to parse the effect of Omicron on survivors and reinfection rates were study strengths. "Unfortunately, although various outcomes were measured in uninfected controls, sequelae symptoms were not," they wrote.

"Further work is required to define what an appropriate comparator group isshould studies be constrained only to test controls without COVID-19 or include those infected by SARS-CoV-2 but unvaccinated? The answer is likely to depend on the chosen research question."

Routen and Khunti called for the provision of sufficient infrastructure to enable global longitudinal study of the epidemiologic factors of COVID-19, especially on the developmental outcomes and new-onset chronic disease in younger people.

"In the short term, outstanding research priorities include the need to improve consistency of classifications of long COVID between analyses, the inclusion of comparator groups (aligned with research questions), the use of large sample sizes for sufficient statistical power, particularly when effects might be small, and stratification of findings by potential explanatory factors (including socioeconomic status, ethnicity, COVID-19 variants, and vaccination status)," they concluded.

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Half of COVID survivors still had symptoms at 3 years, more ... - University of Minnesota Twin Cities

A new study comparing magnetic resonance imaging (MRI) images of patients with long COVID, fully recovered COVID-19 survivors, and healthy controls shows microstructural changes in different brain regions in the long-COVID patients. The findings will be presented next week at the annual meeting of the Radiological Society of North America.

The research is the first to use diffusion microstructure imaging (DMI), a novel MRI technique, which looks at the movement of water molecules in tissues. DFI can detect smaller brain changes than traditional MRI.

MRIs have thus far failed to compare microstructural differences in the brain of patients with long COVID, frustrating clinicians searching for a pathophysiologic explanation of the disorder, which affects up to 10% to 15% of COVID-19 patients.

"Diffusion microstructure imaging (DMI) is a promising approach to fill this gap, as it detects even small volume shifts between microstructural compartments of a neural tissue model," the authors of the study said.

The study included images from 89 patients with long COVID, 38 COVID-19 patients who didn't report long-term symptoms, and 46 healthy controls with no history of COVID-19 infection.

Among participants with long COVID, 53% of patients could not return to their previous level of independence and/or employment due to infection. Cognitive performance was impaired in 41%, 78% said they had fatigue, and 73% had impaired olfaction.

In an abstract on the findings, the authors explain whole-brain DMI-data revealed a volume-shift from the extraneurite compartment into the free water fraction for the gray matter positively associated with the severity of the initial COVID-19 infection.

This study allows for an in vivo insight on the impact of COVID-19 on the brain.

"This study allows for an in vivo insight on the impact of COVID-19 on the brain," said lead study author Alexander Rau, MD, of the University Hospital Freiburg in Germany, in a press release. "Expression of post-COVID symptoms was associated with specific affected cerebral networks, suggesting a pathophysiological basis of this syndrome."

Interestingly, the DMI revealed microstructure changes in patients with long COVID and in those who were infected with COVID-19 but did not develop lingering symptoms.

"We noted gray matter alterations in both patients with long-COVID and those unimpaired after a COVID-19 infection," said Rau. "Interestingly, we not only noted widespread microstructural alterations in patients with long COVID, but also in those unimpaired after having contracted COVID-19."

The authors of the study said that though the findings are intriguing, they do little to explain why some patients develop long COVID and others do not.

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MRI study spotlights impact of long COVID on the brain - University of Minnesota Twin Cities

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.

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1 in 3 US adults worry about respiratory virus infections this fall and ... - University of Minnesota Twin Cities

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.

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Study finds among outpatients with mild to moderate COVID-19 ... - News-Medical.Net