(WISH) Researchers at Northwestern Universitys medical school in Chicago are looking at biomarkers in the blood to see if they hold answers as to why one persons COVID-19 symptoms linger on, while others recover quickly.
Doctors say that although the vaccine for the coronavirus continues to save lives, they do not believe it has an impact on whether or not a person will get long COVID.
This story was created from a script aired on WISH-TV. Health Spotlightis presented byCommunity Health Network.
Keller Scholl got out of quarantine 13 days ago, and hes still not feeling 100%. The itchiness far and away the worst symptom, he says is mostly gone, and now the graduate student just feels exhausted. Im trying to get enough sleep, he says.
Scholls symptoms might be uncomfortable, but they are also of his own making. Thats because he signed up to be a volunteer in the first human challenge trial involving Zika virus, a mosquito-borne pathogen that can cause fever, pain and, in some cases, a brain-development problem in infants. In standard infectious-disease trials, researchers test drugs or vaccines on people who already have, or might catch, a disease. But in challenge trials, healthy people agree to become infected with a pathogen so that scientists can gather preliminary data on possible drugs and vaccines before bigger trials take place. Accelerating a Zika vaccine by a month, a few days, that does a lot of good in the world, says Scholl, who studies at Pardee RAND Graduate School in Santa Monica, California.
Scholl is not alone in his altruism. He was among thousands of people who answered a global call for challenge-trial volunteers during the COVID-19 pandemic. The effort was spearheaded by an advocacy group called 1Day Sooner, which aimed to generate support for intentionally infecting people with the coronavirus SARS-CoV-2 to accelerate vaccine development. Those challenge trials eventually started in 2021 in the United Kingdom.
Scientists deliberately gave people COVID heres what they learnt
But with the pandemic now in most peoples rear-view mirrors, 1Day Sooner has transformed itself into a forceful advocate of challenge trials for many other infections as well as a supporter of trial participants. There are a lot of diseases besides COVID-19 where one day sooner means saving lives, argues Josh Morrison, the groups president and co-founder, who is based in New York City. The group, which says it now has a roster of more than 42,000 people in 166 countries who have expressed an interest in challenge trials, is the biggest organized effort to champion such trials and their participants.
Controlled human-infection models, as scientists call challenge trials, were already on the rise. A 2022 systematic survey identified 284 human challenge trials conducted since 1980, encompassing more than 14,000 participants, with the number of trials almost doubling from the 2000s to the 2010s1. The trials involve gaining consent from volunteers, who are typically healthy and young, and intentionally infecting them in a clinic, where researchers can monitor symptoms and administer treatment if needed. This can help to test the effectiveness of vaccines and treatments quickly and cost-effectively in controlled conditions, before moving on to time-consuming and expensive field trials, which involve enrolling participants and waiting for enough of them to develop a particular infection. For instance, a malaria vaccine endorsed by the World Health Organization (WHO) last month proved its effectiveness in challenge trials before going on to field testing. As with some other clinical trials, such as those testing an experimental drugs safety, participants in challenge trials are usually compensated financially.
Some researchers who have conducted or are aiming to launch challenge trials are starting to work with 1Day Sooner, seeking input on aspects such as volunteer compensation. In September, 1Day Sooner joined dozens of scientists, physicians and other public-health experts to publish a letter arguing that human challenge trials are crucial to developing a vaccine against hepatitis C2. If the trials go ahead, it will partly be thanks to 1Day Sooners advocacy, some researchers say.
But conducting such trials involves ethical scrutiny of the potential benefits and risks. The broad consensus among research ethicists is that the trials are permissible only if the benefits are great, the risk to participants is low and the knowledge they provide could not easily be gained from other studies. Some researchers have questioned whether a 2021 challenge trial of COVID-19 that 1Day Sooner advocated was worth the risk to participants, given that there were more than enough natural infections to adequately test vaccines and treatments at the time. That challenge trial was a bit of a damp squib, says Charles Weijer, a bioethicist at Western University in London, Canada, who is unconvinced that challenge trials were appropriate during the pandemic. I thought it was reckless and unnecessary.
Should scientists infect healthy people with the coronavirus to test vaccines?
Some researchers also worry that 1Day Sooners laser-like focus on challenge trials could lead to missed opportunities to involve people in other types of medical study. Others are concerned that some participants might not fully appreciate the health risks or might be overly incentivized by the high financial compensation that the group has proposed for some trials.
Helen McShane, an infectious-disease researcher at the University of Oxford, UK, who is leading a COVID-19 challenge trial, says she has found 1Day Sooners advocacy helpful, particularly for recruitment. But she and her colleagues already seek input from participants in their trials and keep them updated on findings, McShane says. I wouldnt want an advocacy organization for volunteers to replace volunteers having their own voice.
Backing challenge trials wasnt Morrisons first foray into advocacy or altruism. In 2011, he says, he donated his left kidney to a stranger. It made me feel better than anything else to think I had saved a life, he says. He is a member of the effective altruism movement, which advocates doing the most good with financial donations or other altruistic acts. He later stopped working as a corporate lawyer and, in 2014, co-founded Waitlist Zero, a group that advocates on behalf of living kidney donors.
Morrison was locked down in his Brooklyn apartment during the pandemic when he became interested in challenge trials. He read a March 2020 article arguing that SARS-CoV-2 challenge trials could be done ethically by limiting them to healthy, young people who are at low risk of serious disease, and that they might hasten vaccine development3. He started wondering whether he could help by advocating on behalf of potential participants in COVID-19 challenge trials. I thought about it overnight and immediately felt like this could be the most important thing I could do in my life, Morrison says.
Hundreds of people volunteer to be infected with coronavirus
Morrison quickly co-founded 1Day Sooner with infectious-disease epidemiologist Sophie Rose, who is now a biosecurity policy adviser at the Centre for Long-Term Resilience in London, UK, and Julia Murdza, 1Day Sooners chief operating officer. They started a petition for COVID-19 challenge trials in late March 2020 and, by September 2020, 38,000 people in 166 countries had signed up. A scientific survey of a subset of these volunteers found that they tended to be well off, highly educated and motivated mainly by altruism4. Some, such as Morrison, were part of the effective-altruism community. But the group isnt monolithic, says Alastair Fraser-Urquhart, an undergraduate at University College London who participated in the first COVID-19 challenge trial. 1Day Sooner is a collection of volunteers who think different things, he says.
The group talked to scientists hoping to run such trials, staged debates and town-hall meetings and promoted the idea to politicians in the United States and the United Kingdom, where COVID-19 challenge trials were being seriously considered. When the first such trial went ahead in 2021, led by researchers at Imperial College London, it involved 34 participants aged 1830 and included volunteers such as Fraser-Urquhart, who had signed 1Day Sooners petition.
By then, COVID-19 vaccines had been proved to be highly effective in conventional clinical trials. The goals of the Imperial trial were to establish what dose of SARS-CoV-2 could reliably infect participants and cause only mild or moderate disease a key first step in the development of any challenge model as well as to study the dynamics of infection.
The Imperial study showed that a surprisingly small dose of COVID-19 could infect about half of participants, and that rapid antigen tests identified when people were infectious, even when they didnt have symptoms5. Of those who became infected, all developed mild or moderate disease, and five reported disturbances to their sense of smell that lasted at least six months after infection. A longer-term follow-up study is planned.
Dozens to be deliberately infected with coronavirus in UK human challenge trials
A second UK challenge study, which gave SARS-CoV-2 to people who had previously had COVID-19, is expected to report its results in the next few months. McShane says COVID-19 human challenge studies have been demonstrated to be safe, adding that the two UK studies have been justified by providing valuable data, and that they could further identify immune responses that help people to fend off the virus.
But Weijer is not the only bioethicist to have raised concerns about COVID-19 challenge trials. The findings might have been a let-down to the thousands of people who answered 1Day Sooners call, says Seema Shah, a bioethicist at Lurie Childrens Hospital in Chicago, Illinois. Challenge trials, she says, didnt make as much difference as those people were hoping or expecting. Shah worries that the groups focus on challenge trials was misplaced, and thinks it might have made more of a difference if it had helped to address gaps in recruitment for COVID-19 vaccine trials, such as the exclusion of pregnant people.
Morrison stands by the ethical arguments for COVID-19 challenge trials, but says he didnt fully appreciate the scientific complexity and time involved in running them, especially during a pandemic; it can take more than a year to develop a challenge model before vaccines and treatments can even be tested. He still hopes that such trials can help to test next-generation COVID-19 vaccines, by providing a clearer read-out of their efficacy especially in terms of reducing transmission and mild disease than would be possible with field trials. But if SARS-CoV-2 challenge trials yield only scientific insights into the virus and dont contribute to better vaccines, it will be a missed opportunity, Morrison concedes.
Intentionally infecting someone with hepatitis C virus (HCV) as part of a human challenge trial would have once been in the category of no, you cant possibly do that, says Weijer, because the health risks were too great. Left untreated, chronic HCV infections can cause cirrhosis, liver failure and death. By contrast, other pathogens typically tested in challenge trials have involved short-term, lower-risk infections.
But in the past decade, the ethical equation for HCV has changed because of a new generation of antiviral drugs that have a cure rate approaching 100% meaning they leave almost no detectable virus. This makes a challenge trial conceivable, researchers say. With the urgency of the COVID-19 pandemic waning alongside interest from participants in challenge trials, say investigators Morrison wanted 1Day Sooner to identify a way of showcasing the potential of challenge trials to make a difference in global health. The groups continued focus on challenge studies stems from the trials track record of delivering advances in this field, Morrison says. The potential risks of these trials and the demands they put on participants tend to be greater than for most other studies, creating the need for an advocacy group such as 1Day Sooner, he argues.
The next generation of coronavirus vaccines: a graphical guide
The group consulted with infectious-disease specialists and ultimately decided to focus on HCV after Morrison read a 2021 article co-authored by leading HCV experts, including Charles Rice, a virologist who shared the 2020 Nobel Prize in Medicine or Physiology for discovering HCV6.
HCV is responsible for 1.5 million new infections and 290,000 deaths each year, according to the WHO. Antiviral drugs are effective but costly, and have to be taken for up to several months, so researchers are seeking a vaccine. But enrolling people who are at risk of HCV infection, such as users of injection drugs, in vaccine trials has proved difficult, hindering vaccine development. The push for HCV vaccines was dealt a blow in 2021, when a trial involving hundreds of injection drug users showed that a once-promising vaccine was ineffective7. Now, Rice and other HCV specialists argue that challenge trials involving volunteers could be the only realistic path to a vaccine.
1Day Sooner started advocating for HCV trials in 2021 and reran its COVID-19 playbook organizing workshops, writing open letters and opinion pieces and lining up would-be participants. Its a chance to learn from the COVID experience and find places that we can do better, says Morrison. The group has even helped to broker potential funding for trials in Oxford, UK, and in Toronto, Canada, from Open Philanthropy, a non-profit organization aligned with effective altruism in San Francisco, California, that has provided around 40% of 1Day Sooners support as part of its funding for global health.
The time is right to make this happen, says Ellie Barnes, an immunologist and liver specialist at the University of Oxford, who would lead the HCV challenge trial there. Without this, it will be impossible to progress the vaccine field.
Testing HCV vaccines could mean leaving people infected for up to 46 months, says Jake Liang, a physicianscientist at the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland. About one-quarter of HCV infections go away naturally, and a too-short infection period could mask a vaccines true efficacy against chronic infection. Any trial would have to pass ethical scrutiny before it can proceed. If were going to do this, were going to do it right, says Liang.
If HCV challenge trials do go ahead which could happen as early as 2024 Morrison would like to see 1Day Sooner and its participants have a say in how they are run. A survey of people in the groups registry found strong support for HCV trials and a willingness to endure being infected for several months, particularly if it meant that results would provide a clearer signal of vaccine efficacy or trials would require fewer participants. Respondents main motivation for thinking about participation was to help others, but most saw no conflict between this and being well compensated8.
The authors of the study, most of whom are employed by or affiliated with 1Day Sooner, proposed that participants should be compensated around US$20,000 for a six-month trial, a significant jump from the 2,0005,000 (US$2,5006,200) or so that challenge studies usually offer. They also said that plans for how the trial will be conducted should be made public a step they have campaigned for with COVID-19 trials and that results should be disseminated quickly and openly to maximize their benefit to society.
Hearing the views of potential trial participants has been helpful, says Barnes. She is interested in the idea of improving compensation for volunteers but worries that large sums could be seen as unduly inducing participation and might not gain ethical approval in the United Kingdom. Paying somebody 15,000 that is a potentially life-changing amount of money, she says.
Scholl sees no conflict between his desire to do good and the $4,875 he received for taking part in the Zika challenge trial. The two things I want are a successful Zika vaccine and money, he says. It feels a little crass saying the latter, but Im a grad student. I dont make much.
Scientist deliberately gave women Zika heres why
The itchiness notwithstanding, Scholl says he didnt mind his nine days in quarantine during the trial, which was run at Johns Hopkins University in Baltimore, Maryland. The Wi-Fi was good, he says, and it gave him a chance to catch up on his reading and films. The fatigue he experienced is now gone. Researchers first proposed Zika challenge trials during the 201516 outbreak, but they were considered ethically acceptable only once their value clearly outweighed the risks, says Shah, who led a 2017 ethical review of the proposal.
Morrison thinks that giving trial participants such as Scholl a greater say in how studies are run will ultimately benefit research by encouraging a greater number of better-engaged volunteers to take part. His long-term vision is for 1Day Sooner to become a union for research volunteers that, while promoting research that is valuable to society and arguing for better pay and working conditions, emphasizes participants agency and their right to take part on their own terms.
The group doesnt accept funding from drug or vaccine makers, but recent events have shone a spotlight on some of its financing. In 2022, it received $375,000 from the FTX Foundation, the philanthropic arm of the collapsed cryptocurrency exchange FTX. Sam Bankman-Fried, the co-founder of FTX, was convicted of wire fraud and other charges stemming from his role at the firm in early November.
Morrison says the group is in the process of returning the money, and that the experience has led it to be more diligent about investigating potential supporters. Many of its funders who have contributed a total of $7.8 million as of July 2023 are philanthropies linked to the technology industry, including Open Philanthropy, which is largely funded by Facebook co-founder Dustin Moskovitz and his wife Cari Tuna.
One of Morrisons biggest worries is that 1Day Sooner hasnt yet justified the investment. The group is now expanding beyond challenge trials: one idea is to stimulate research into effective ways of improving indoor air quality to reduce transmission of airborne pathogens. A spin-off group called 1Day Africa (which was to be partly funded by the donation from the FTX Foundation) aims to improve vaccine equity and empower study participants on the continent.
What keeps me up at night? I dont feel yet that weve had a significant win, Morrison says. It only matters if you accomplish something.
LONDON Britains coronavirus inquiry is in full swing and its not just the top political players squirming.
U.K. Health Security Agency chief Jenny Harries Englands deputy chief medical officer at the height of the pandemic is slated to appear Tuesday through Wednesday and could face awkward questions of her own.
Harries burst into the public consciousness as the virus spread in 2020, with a host of utterances that were meant to reassure worried Brits but ended up sowing more confusion.
POLITICO rounds up Harries most controversial comments plus her Whitehall promotion at the end of it all.
Back in the hyper weird moments of early 2020, Harries took part in avideo Q&A on coronavirus with Prime Minister Boris Johnson.
In the clip posted March 11, 2020 when COVID-19 was already rapidly spreading Harries told Johnson that big gatherings are not seen to be something which is going to have a big effect. She argued it was not worth disrupting peoples lives over the virus.
After lockdown-wary Johnson pointed out that other countries had been canceling big events and doing things that are not necessarily dictated by the science, the top medical official happily agreed that the U.K.s plan was the right one.
But the interview was timed just after the four-day Cheltenham Festival kicked off and was interpreted as a big thumbs up for people to attend it and the raft of big Champions League football fixtures around that time. Around 150,000 people attended the big horse-racing event, which both aformer chief science adviserand theCommons health committeelater linked to furthering the spread of the virus.
In her fireside chat with Johnson and in other interviews Harries also left the fence most other experts were sitting on when it came to face masks.
At the time, Brits were panic buying masks from high street pharmacists and the health service was grappling with a shortage of personal protective equipment. Experts at the time warned the science was inconclusive on whether they actually help or not.
But Harries went further, and told a nodding Johnson that its usually quite a bad idea to wear a mask if a healthcare professional hasnt asked you to wear one. She also told the BBC masks could potentially trap the virus.
A few months later masks became mandatory in shops and on public transport. The government eventually recommended their use in schools too, despite Harries arguing the evidence is not strong for their use in classrooms.
Early in the pandemic, Tory former Cabinet minister Rory Stewart urged Johnsons government to follow the example of China and impose sweeping restrictions to stop the spread of the virus. I would be, for example, shutting down all schools in London now, he urged in March 2020.
Cue Harries, who was sent out on to the airwaves to curtly reject Stewarts advice on a scientific basis and stress that the government had its own robust plan, thank you very much. Two weeks later, Britain entered a national lockdown, with the schools firmly shut.
Mass testing is not an appropriate intervention for Britain anymore, Harries explained on March 26, 2020 after the U.K. had moved away from an initial strategy of trying to test and trace those with symptoms.
This was despite the World Health Organization at the time urging countries to test, test, test, something which Harries argued was more applicable to other low and middle income countries than it was to Britain.
A few weeks laterand senior officials wereadmittingthe U.K. got it wrong on COVID testing and had failed to increase it quickly enough, as they soon desperately tried to catch up with mass-testing countries like South Korea. Harries herself laterblamedthe U.K.s poor testing capacity for the virus spread.
Harries raised some Westminster eyebrows in 2021 when she was promoted to become the first ever chief executive of the brand new U.K. Health Security Agency which contained the NHS Test and Trace system.
A key part of the agencys brief is ensuring Britain is better prepared for the next pandemic. Harries was later made a dame in 2022 under the U.K.s honors system.
TUESDAY, Nov. 28, 2023 (HealthDay News) -- For patients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs (DMARDs), receiving a fourth COVID-19 mRNA vaccine reduces the risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, according to a study published online Nov. 15 in The Lancet Rheumatology.
Jennifer S. Hanberg, M.D., from Brigham and Women's Hospital in Boston, and colleagues conducted an emulated target trial using observational data to compare receiving versus not receiving a fourth mRNA vaccine dose among patients with systemic autoimmune rheumatic diseases who were prescribed DMARDs. Data were included for 4,305 patients: 3,126 received a fourth dose, and 1,179 did not. After emulation of the time-sequential once-per-week trials and overlap propensity score weighting, both groups included 2,563 adults.
Of the 2,563 participants, 54.3 percent had rheumatoid arthritis; the most frequent treatments used were conventional synthetic DMARDs and biological DMARDs (58.1 and 39.3 percent, respectively). The researchers found that the risk for SARS-CoV-2 was lower among patients receiving versus not receiving a fourth vaccine dose (hazard ratio [HR], 0.59). The risk for admission to hospital or death within 3 to +14 days of SARS-CoV-2 infection was also lower with receipt of a fourth vaccine dose (HR, 0.35).
"Patients with systemic autoimmune rheumatic diseases should be encouraged to receive at least four doses of mRNA vaccines," the authors write.
Several authors disclosed ties to the biopharmaceutical industry.
Abstract/Full Text
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TUESDAY, Nov. 28, 2023 (HealthDay News) -- Fluvoxamine does not reduce duration of COVID-19 symptoms in patients with mild or moderate COVID-19, according to a study published online Nov. 17 in theJournal of the American Medical Association.
Thomas G. Stewart, Ph.D., from the University of Virginia in Charlottesville, and colleagues from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-6 Study Group assessed the effectiveness of fluvoxamine versus placebo for treating mild to moderate COVID-19. The analysis included 1,208 participants randomly assigned to receive fluvoxamine (50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days; 601 patients) or placebo (607 patients).
The researchers found no differences in time to sustained recovery between the two groups (adjusted hazard ratio, 0.99; 95 percent credible interval, 0.89 to 1.09; P for efficacy = 0.40). Similarly, in both groups, unadjusted median time to sustained recovery was 10 days. No deaths were reported, but 35 participants reported health care use events (defined as death, hospitalization, or emergency department/urgent care visit), including 14 in the fluvoxamine group and 21 in the placebo group (hazard ratio, 0.69; 95 percent credible interval, 0.27 to 1.21; P for efficacy = 0.86). Seven serious adverse events occurred in six participants (two with fluvoxamine and four with placebo).
"Although one-third fewer health care use events occurred in the fluvoxamine intervention group, the difference did not meet prespecified decision thresholds for concluding a treatment effect," the authors write.
Several authors disclosed ties to the pharmaceutical industry.
Abstract/Full Text
Editor's Note
Respiratory virus season is ramping up across the United States, and the US Centers for Disease Control and Prevention is warning that low vaccination rates are leaving many at risk.
About 15% of adults and 5% of children have gotten the latest Covid-19 vaccine, according to CDC data through mid-November.
Heres the bottom line: COVID-19 vaccine uptake is lower than wed like to see,and most people will be without the added protection that can reduce the severity of COVID-19, the agency wrote in anupdateon its website.
Covid-19 hospitalizations are on the rise again, with more than 16,000 new admissions during the week ending November 11. Hospitalization rates are lower than they were at this time last year but nearly three times higher than they were during this summers record low.
There are a number of reasons why its important for people to get the latest Covid-19 vaccine, CDC Director Dr. Mandy Cohen said.
This Covid virus has changed, and you want the most updated Covid vaccine to protect you as we go into this winter season, she said. Second, we know that the protection that you get from either having Covid before or being vaccinated before decreases over time. Vaccination can also help reduce the risk for long Covid, she said.
Flu and RSV levels are also increasing, but most respiratory virus hospitalizations this season have been among people with Covid-19, CDC data shows. About a third of adults and children have gotten their flu shot this season, and about 14% of older adults have gotten the new RSV vaccine.
COVID-19 isstill an important cause of hospitalization and death, especially for older adults and people with certain underlying medical conditions, the CDC wrote in the latest online update. COVID-19 vaccines dont prevent every infection thats true of lots of vaccines butthey can reduce illness severityin people who get vaccinated but still get sick, helping to save lives, reduce hospitalizations, and prevent trips to the doctor.
This winters respiratory virus season is just beginning, and now is a great time to get vaccinated, Cohen said. The sooner the better. It does take about two weeks for your body to build up the maximum amount of antibodies, but its never too late.
The current Covid-19 vaccination rate is significantly higher among seniors, but more than two-thirds of this high-risk population has not gotten the latest vaccine, according to the CDC.
Because older people are much more likely toget hospitalizedanddie from COVID-19, it is critical that this population get vaccinated to protect themselves against severe outcomes from COVID-19, the CDC wrote.
The CDC also found racial and ethnic disparities in Covid-19 vaccination rates, with uptake about half as high among Black and Hispanic adults compared with White adults.
However, separatesurvey datafrom KFF found that Black and Hispanic adults are much more likely than White adults to say they have gotten the new vaccine or plan to do so.
Overall, the KFF survey found that most adults in the US are not worried about getting sick with Covid-19 or spreading it over the holidays. Only about half say they plan to get the latest vaccine, and theres a similar split around plans to take other precautions, such as masking or avoiding crowded places and travel.
This systematic review and meta-analysis provides a comprehensive and in-depth examination of findings from studies on long-term cardiac complications of COVID-19. Up to July 2023, at least 150 studies examined 49 different long-term cardiac complications of COVID-19. Chest pain and arrhythmia were the two most widely reported complications. These studies varied substantially in different aspects of study design, and only a quarter of them were of high quality based on our quality assessment. Meta-analysis identified high heterogeneity across studies for almost all cardiac complications, and subgroup analyses showed systematic differences in reported prevalence by the quality and characteristics of included studies. Most strikingly, we observed that studies of high quality reported much lower prevalence of different cardiac complications compared to studies of medium and low quality. To our knowledge, this is the first meta-analysis that quantitatively examined how reported findings of studies on long-term cardiac complications of COVID-19 differ by study quality and characteristics.
It is evident that many COVID-19 survivors have experienced lasting cardiac complications, even those who did not have previous cardiovascular diseases or comorbidities, and who had a low risk of cardiovascular diseases before the pandemic. To date, multiple reviews have examined the long-term cardiac complications of COVID-19 (Additional file 1: Table S6) [4, 5, 9,10,11,12,13,14,15, 28,29,30,31,32]. For example, several previous systematic reviews and meta-analyses also quantified chest pain and arrhythmia as two of the most common long-term cardiac complications, with prevalence estimates for chest pain ranging from 5 to 16% and prevalence estimates for arrhythmia ranging from 10 to 11% [9, 29, 30, 32]. Our prevalence estimates of these two complications broadly agree with these previous findings. A probable source of minor differences in prevalence estimates comparing our study to previous studies is that different systematic reviews and meta-analyses used different inclusion criteria to select studies.
Besides being more updated and comprehensive in terms of article search, our study examined whether there are systematic differences in reported findings by the quality and characteristics of included studies. Meta-analysis stratified by these factors shows that studies of low quality, small sample size, unsystematic sampling method, and cross-sectional design are more likely to report higher prevalence estimates of long-term cardiac complications. For example, the prevalence of chest pain among studies of low quality (22.17%) was five times higher than that among studies of low quality (3.89%). Such patterns were also observed for the prevalence of arrhythmia (studies of low quality vs. high: 24.09% vs. 2.68%) and other less examined long-term cardiac complications. This observation shows how sensitive reported findings can be depending on the quality and characteristics of studies on cardiac complications of COVID-19. Therefore, it is important to take these factors into account and better interpret the findings from these studies.
In our quality assessment, we determined that around 25% of 150 included studies were of high quality and the remaining 75% were of medium or low quality. The small number of high-quality studies demonstrates the urgent need to improve the quality of studies investigating the long-term cardiac complications of COVID-19. Due to the large number of studies included in this systematic review and meta-analysis, we did not enumerate their references. A list of these studies ordered by total quality assessment score can be accessed in Additional file 1: Table S2. A key feature among included studies of medium or low quality was that they were predominantly based on clinical or hospital samples. These studies usually had small sample sizes and had no or only one point of follow-up. While relatively small clinical or hospital-based studies, which are often easier to conduct in shorter periods, can be useful to establish preliminary evidence of an association, especially in an emergent situation such as a pandemic, they often lack population representativeness and statistical power to make broader conclusions about the hypothesized relationships. Furthermore, cross-sectional studies cannot establish the temporality required to infer any causal relationship and prohibit examinations of changes in complications over time.
Interestingly, we observed that studies published in later years (2021 to 2023) had a higher quality assessment score than those earliest studies published in 2020. This shows a general trend of improvement in study quality over time. However, similar quality scores were observed for studies published in 2022 and 2023 (average quality score 9.9 vs. 9.8), which may indicate a recent stagnation in the improvement of study quality on this topic. It is interesting to examine the trend of study quality as more related studies are coming out.
Based on the above findings, we formulated some recommendations for the design and analysis of future studies on long-term cardiac complications of COVID-19 (Table 2). Many studies adopted convenience sampling schemes, which hinders the interpretability and generalizability of their findings. Therefore, it is important to conduct systematic sampling, which can facilitate a continuing and meaningful exploration of the data collected and underpin clinical research. The majority of included studies only assessed long-term complications at a single time point. It is therefore challenging to examine how the long-term complications may change over time. Many studies did not distinguish between long-term complications following COVID and pre-COVID complications at baseline level. Most COVID-19 studies on other types of long-term complications have used similar data sources and analytical methods and will have similar methodological problems as we discussed above. Our study for the first time quantified how reported findings can differ by study quality and selected characteristics. This demonstrates the importance of addressing these methodological problems for COVID-19 studies reporting on long-term cardiac complications and other complications as well.
Although pathophysiological mechanisms underlying COVID-19 cardiac complications remain unclear, studies suggest that the chronic inflammatory response may be hyperactivated by persistent viral reservoirs in the initial acute phase, which may lead to post-acute COVID-19 cardiovascular sequelae [4, 5, 13]. Studies have shown that over 20% of patients with acute COVID-19 had evidence of cardiac injury, even if they did not have underlying cardiovascular diseases or pre-existing comorbidities [33,34,35,36]. It is hypothesized that viral invasion through binding angiotensin-converting enzyme-2 (ACE-2) causes a cytokine storm and triggers systemic hyper-inflammation, which can affect multiple organ systems and induce cardiac injury as one of the severe complications [4, 15]. Persistent chest pain and arrhythmia may be indicative of underlying cardiac abnormalities and damage resulting from systematic hyper-inflammation and/or viral myocarditis affecting the cardiac conduction system. It is critical for clinicians to thoroughly examine patients with long-term cardiac complications of COVID-19, especially for survivors with pre-existing cardiac conditions and other high-risk comorbidities.
Our systematic review and meta-analysis have multiple strengths. First, to our knowledge, this is the most comprehensive systematic review focusing on long-term cardiac complications of COVID-19. It included preprints and articles published in different languages and the global network. Second, in an effort to ensure our results were up to date, we regularly updated our search to capture articles published from the early phases of the pandemic to the most recently published studies. Our review will serve as an invaluable resource for updating researchers and clinicians on key discoveries around long-term cardiac complications of COVID-19. Third, we assessed the quality of included articles from the perspective of study design and epidemiologic principles and provided detailed recommendations on future long-COVID epidemiologic research. The NOS tool assessed the quality of each included study and potential risk of bias, and the GRADE approach determined the level of evidence. Fourth, we performed meta-analysis and subgroup analyses to examine patterns of reported findings, and we observed systematic patterns of reported findings of existing studies.
Our study also has several limitations. First, studies included in our systematic review and meta-analysis are highly heterogeneous. We, therefore, performed subgroup analyses by multiple characteristics, and we believe that existing heterogeneity across studies makes it difficult to generalize our results to the general population. Second, we were unable to stratify our meta-analysis by the length of follow-up because of widely varying follow-up times and different index dates of follow-up across studies. We intended to report the meta-analysis results by hospitalization status; however, most studies have a mixed cohort of inpatients and outpatients, and some studies did not report this information. Such variations in design and lack of detailed data made the stratified results hard to interpret. Finally, we could not stratify our analyses based on prior comorbidities, history of cardiovascular diseases, treatment or medication use for cardiac complications, or COVID-19 vaccination status due to limited reporting of such information, particularly in the studies published during the initial stages of the pandemic. This is because much of the related information was not clearly given in most existing studies. We plan to conduct these analyses once more data on these factors becomes available.
As the pandemic comes to an end worldwide, we may live together with COVID-19 in the coming years, and the epidemiology of long-term cardiac manifestations of COVID-19 might change over time. We think that multiple factors may strongly influence the prevalence or rate of long-term cardiac complications of COVID-19, including a shift in the demographic affected from primarily older people with comorbidities at the beginning to the general population, the availability of vaccination, treatment, and in-home testing, and the emergence of new COVID-19 variants [5, 37]. In future studies, how these factors may influence long-term cardiac complications of COVID-19 should be carefully examined.
In conclusion, we found there were diverse manifestations of cardiac complications, and many can last for months and even years. There is substantial heterogeneity in terms of study design and systematic differences in the reported prevalence of complications by study quality and characteristics. Specifically, we found that studies with low-quality, small sample size, unsystematic sampling method, or cross-sectional design were most likely to report a higher prevalence of complications among individuals who survived COVID-19. We believe that a deeper understanding of long COVID is currently prevented by the limitations of the published literature. Our study underscores the need to conduct high-quality studies on long COVID and the importance of long-term cardiac surveillance of COVID-19 survivors.
U.S. households are now eligible to order an additional four at-home Covid-19 tests free of cost through the government.
Residential households in the U.S. can now submit an order throughCovidtests.govfor four individual rapid antigen Covid-19 tests.
Orders started to ship on November 27, according toUSPS. People without an internet connection can call 1-800-232-0233 (TTY 1-888-720-7489) to request tests.
The U.S. government had suspended the rapid test distribution program earlier in May, then reopened it in September. Residents who havent placed an order since the program reopened can place two orders, which will provide eight tests in total, according to USPS.
Covid-19 rapid tests can be taken at home and can be used regardless of whether someone has symptoms. The tests should work through the end of the year; some of the dates on the tests may show that they are expired, but the US Food and Drug Administration hasextended those dates.
The U.S. Centers for Disease Control and Preventionrecommends people testif they have any Covid-19-like symptoms including a sore throat, runny nose, loss of smell or taste, or a fever. People may also want to test before they are going to be a part of a large event, like a concert or a conference, particularly if people are not up-to-date on their vaccines. Antivirals are available to treat Covid-19 and flu, and testing can help determine which medication is needed.
Covid-19 hospital admissions and emergency department visits are once again on the rise after a few weeks of downturn, according to theCDC. For the week ending November 11, the percentage of Covid-related emergency department visits was 1.4%, or just over 16,200 people similar to rates seen throughout this month and last month.
Overall, outpatient visits for flu-like illness are lower than they were at this time last year but higher than in the previous four seasons. CDC forecasting suggests that this respiratory virus season will result in about the same number of hospitalizations as last season.
Seasonal flu activity is alsoincreasingin most parts of the country with flu-like activity labeled as high in New Mexico, Florida, Alabama, Mississippi, Georgia and South Carolina, according to the CDC. There have been at least 780,000 illnesses, 8,000 hospitalizations, and 490 deaths from flu so far this season, the agency estimates.
More than a third of adults and nearly a third of children have gotten their flu shot this year, CDC data shows. About 14% of adults and 5% of children have gotten the new Covid-19 vaccine while 14% of older adults ages 60 and up have gotten the new RSV vaccine.
