The Final Countdown for CLoCK, the paediatric study in Long Covid.

Is Long Covid really PMS?! The CLoCK Files Part 3.

Headlines

The CLoCK Study, from the Psychological Medicine department at UCL, is a longitudinal research project investigating Long Covid in Children and Young People. On the 4th December it published the 24 month cohort results in Nature, with a global fanfare of hope in the media.

Our findings show that, for teenagers who fulfilled our research definition of long Covid three months after a positive test for the Covid virus, the majority have recovered after two years. Prof. Terence Stephenson.

Media about the CLoCK Study

Sounds great?! But is it that simple? Is a sigh of relief truly justified? We’ve been here before. You can find our investigations into the issues around CLoCK in our Files Part One and Part Two. We need to get our magnifying glasses out and examine the first-hand source. In this article, we will take a closer look at the authors: the WHO definition of paediatric Long Covid; the numbers and methodology; nomenclature; the implication of the involvement of psychological and pre-pandemic factors and the wild assertion that PMS is somehow involved.

Majority Findings, Good News?

The Children and young people with Long Covid (CLoCK) study found that 70 per cent of children aged between 11 and 17 had recovered within a 24-month period. Daniel Keane, Evening Standard.

Now, Stephenson’s statement about the majority recovering is technically correct according to their findings, with c.70% recovering. But a crucial detail is not emphasised: 30% don’t recover. If this can be extended to the population level, it represents a very significant number of children who do not recover from a widespread, unmitigated disease. We know a small percent of a large number is considerable. If we are talking 30%, we have a national emergency.

This is good news but we intend to do further research to try to better understand why 68 teenagers had not recovered. Prof Terence Stephenson

We would disagree that this is good news; there has been no intervention to prevent or try to treat Long Covid in children, with a large cohort not recovering. A deliberate slant colours the presentation of these findings. Headlines matter, PR matters, narrative matters. The danger is with this ‘reassuring’ news the implication is that we don’t need to act, as most recover.

But at least it’s consistent with the minimising attitude towards this crisis.

Authors

Let’s look at the authors. There is more detail in this in CLoCK Files Part One. We have a group of career influencers in the behavioural model of ME and Long Covid here; Chalder, Shafran and Segal etc. We can even see Esther Crawley hidden in the CLoCK consortium heading, although what exactly has happened to her, as she’s disappeared from Bristol University and clinical practice, no one is quite sure.

Ladhani, the UK clinical lead for Covid in children, deserves his own special category of failing upwards, due to his determined anti-mask, anti-vaccine, anti-lockdown agenda. Please see Karam Bales on Twitter and in the Counter Disinformation Project for a more detailed analysis. Especially on his links with republican linked Hoeg and the Norfolk Group, a right-wing Brownstone Institute endeavour.

Definition

Data reliability in research depends entirely on the accuracy of data entry and interpretation. Agenda and preconceived entrenched views matter. Bias in, bias out.

The researchers used this definition for their new study, which examined data from 12,632 young people who had a PCR test for SARS-CoV-2 (the virus that causes Covid-19). (Pereira et al. 2024)

The definition of Long Covid in CYP by WHO involved individuals from the CLoCK consortium. Predictably, the deck is already stacked to a vague, wide-cohort, behavioural model in the definition. The main issue is that there is no mention of PEM/PESE; fatigue and anosmia are linked to anxiety and all other symptoms are ‘non-specific’ and therefore dismissed.

It was noted that “anxiety” is a problematic symptom in children, as young children often present their somatic unwellness with “somatopsychic” symptoms and adolescents may be anxious for many reasons that might not directly be virus-related. WHO definition

Numbers

We saw in the media that CLoCK is the largest study on paediatric Long Covid, adding to its findings, authority, with 31012 enrolled. However, the division and high dropout rate indicate that the main findings ultimately come from a small subset.

Of the 12,632 young people in total, there were 943 who had tested positive when first approached and who provided answers at every time point: three, six, 12 and 24 months after their original test.

Of these 943 young people, 233 met the research definition of long Covid three months after their initial positive test. At six months, 135 continued to meet the research definition of long Covid. At 12 months, 94 continued to fulfil the long Covid research definition.

However, only 68 of these 943 children and young people (7.2%) continued to fulfil the long Covid research definition when contacted 24 months after their initial positive test. (Pereira et al. 2024)

These figures highlight two critical, yet understated, points: first, 25% of children who tested positive at three months had Long Covid; secondly, the leap from a 31,000-person study to a focus on 68 non-recoverers.

A QUARTER of all children who tested for Covid had symptoms at three months. A quarter, that needs repeating. In the strict attendance culture of education and with exams a possibility in that time frame, three months is too long to experience a preventable disease. That 7% after two years still have Long Covid is not good news. Children are not cannon fodder. A positive spin would be substantial systemic reform within schools.

We’ve known since the 1950’s that viruses tend to leave a similar proportion of people with post-acute viral symptoms. This isn’t the first epidemic. If the authors had investigated previous research and engaged with the literature this could have been reasonably affirmed, and the funds directed towards finding biomarkers, pathophysiology and effective treatments.

In one report, 6% of a community of 2,500 people—most young or middle-aged adults—became suddenly ill with an infectious-like illness followed by at least 5 months of a cyclic, debilitating illness characterized by fatigue, cognitive impairment (confirmed on objective testing) and pain (Komaroff et al. 2023)

The ONS figures present a very different story: one of growing numbers and the plight of children not recovering enough to stem the crisis. Worse, the ONS have had their funding cut and we don’t have regular updates.

Comparing ONS and CLoCK stats

With the lack of actual biological research on children, we do not know what Covid is doing to the paediatric population. Surely the precautionary principle should be in play when a neurotropic virus is prevalent.

Methodology

But the problems go deeper. The elephant in the room is a fundamentally flawed and irrelevant methodology that makes the findings tenuous at best.

CLoCK control group and subdivision design

Many of the methodological issues are detailed in CLoCK Files Part One. The cohort’s control group subdivision is flawed. CLoCK was designed in reaction to the authors’ belief that Covid was short-term and that herd immunity would kick in, allowing a control group. Yet, because Covid is a coronavirus, the continual reinfection of the population means a control group is impossible.

Their response involves four subdivisions, which attempt to account for potential reinfection. However, something strange happens. In the initial test negative groups (N), they rely on ‘a report of a positive test’ yet in the initial test positive groups (P) they do not require a test but only a ‘report of subsequent reinfection’. This isn’t consistent and allows for a substantial skew.

after taking a PCR test for the Covid virus between September 2020 and March 2021. They also asked them to recall their symptoms at the time of taking the test. (Pereira et al. 2024)

The next matter: testing. Two years into the pandemic, who can access PCR tests? Who even tests? Reliability of testing is also a concern. Then there is that nearly half of all Covid cases are asymptomatic. So, is the control group really negative?

Science needs structure and methodology in its design to objectify its results, but when the structure becomes more important than the reality, then we have a problem Houston.

The authors’ preconceived bias enabled an invalid method, and they did not further adapt to the developing nature of the pandemic. CLoCK basically ate up the research funding for UK paediatric research, all £1.9 million. Not the done thing in research - they really should have given the funds back so they could be invested in trying to find the pathology of the disease.

Control Group Contamination

What occurred in the UK (and worldwide) is that almost every child has been permitted to contract Covid, rendering the control group sub-division nonsensical. However, the results show this.

Although 25-30% of all groups met the PCC Delphi research definition at 24 months post-index-test (Pereira et al. 2024)

Yes. you read that right. ALL groups, including the negative control group had Long Covid at two years in the range of 25-30%. So, either we have a huge crisis in children and young people, or there is something wrong with the methodology and the definition, or both.

This is where it gets a little fuzzy, and it comes down to trial design and language. In these behavioral studies, there must be sufficient flexibility to suggest a link between mental health issues and the illness. Enough so that it can’t really be classified as a disease but a sense of non-specific symptoms that can be curtailed into psychology and psychiatry. Yes, dear readers, we’ve been here before. Let’s look at the stats they reported.

Nomenclature

However, symptom profiles differed by infection status. In general, the NN group had the lowest prevalence of symptoms, with the NP and PN groups having a higher prevalence and the PP group having the highest prevalence. For example, for tiredness, the prevalence was 38% (1736/4534) in the NN group, ~45% in the NP (1070/2402) and PN (2336/5177) groups, and 48% (249/519) in the PP group (Pereira et al. 2024)

Can you see where the problem is? Tiredness. Not PEM, not even fatigue but tiredness. In the CLoCK questionnaire they ask how the CYP is feeling ‘right now’. It repeatedly asks how children are feeling ‘Today’. This naturally will capture those who are feeling tired but who don’t have PEM or even an illness. It’s the same open goal criteria problem in ME/CFS, by the people who widened and followed this research pattern pre-pandemic.

Throughout the paper they don’t and won’t name ME/CFS. It’s chronic post-viral syndrome or post- infective fatigue syndrome.

Recovery

We also have to assess, ‘what is recovery?’ This isn’t addressed in the paper. But Long Covid is a remitting and relapsing illness. The snapshot technique used will not capture sustained recovery. With Covid still ubiquitous, reinfection is a serious risk factor for those whose symptoms have remitted. Again, this isn’t a black and white area, which CLoCK fails to apprehend.

Mini-Summary

To summarise, not only do we have: no mention of PEM or POTS; extensive issues with Covid testing over the two-year period; a snapshot approach that allows the capture of people without Long Covid; faulty trial design that means the four subgroups are irrelevant and the use of the CFQ, the Chalder Fatigue Scale. We also have subjective PROMS that are at high risk of bias and unrealistic reporting and results.

Finally, the study primarily relied on self-reported symptoms and questionnaires, which may lack the precision of detailed, objective clinical assessments. However, it could be argued that this a strength of the study at this point given that there is no definitive diagnostic test to determine if a patient has PCC and we need to learn about new emerging symptoms, or re-emerging, chronic symptoms from those who are experiencing them. (Pereira et al. 2024)

Funnily enough, they argue that the use of subjective reporting is a strength of the study. We know from the NICE evidence review for the ME/CFS Guidelines that ALL the evidence for CBT and exercise for ME/CFS was graded low or very low precisely because of subjective PROMS. Perhaps £1.9 million would better fund definitive diagnostic testing than this flawed project? Instead, we are no further forward five years into the pandemic.

Abnormal Psychology

Surely that’s enough you say?! Can we stop there? Not quite. There is a reason for bad science. It’s not done through stupidity or lack of proficiency. It is performed to allow the verification and justification of the authors’ ideological stance - that there are behavioural and psychological factors involved in Long Covid. This isn’t disinformation where there is purposeful deception to create propaganda, it is misinformation where they believe in what they say - but it just isn’t accurate or true.

raising questions about the role of the initial SARS-CoV-2 infection in their aetiology 22,23. For example, those who did not fulfil the PCC Delphi research definition had SDQ scores broadly in-line with normative data from 11-to-15-year-old British CYP pre-pandemic (i.e. mean (SD): hyperactivity = 3.8(2.2); emotional symptoms = 2.8 (2.1); peer problems = 1.5(1.4); conduct problems = 2.2(1.7))24. Likewise, the SWEMWBS score among those who did not fulfil the PCC Delphi research definition was similar to those reported pre-pandemic in 10-to-16-year-old Danish school children (mean = 23.33 (SD = 3.78)) (Pereira et al. 2024)

Remember that this study is done in the department of Psychological Medicine. One of the main hypotheses in the initial stages of the pandemic by the CLoCK team is that Long Covid was connected to ‘Lockdown anxiety’. So, they are essentially trying to cast doubt that Long Covid is causal to Covid infection. That it is abnormal psychology that influences Long Covid as well, and it can neatly be dropped in the psychological medicine field and mental illness.

That some CYP will go on the develop persistent symptoms after acute SARS-CoV-2 infection is undeniable, consistent with other post-viral syndromes, and there is emerging evidence of viral persistence in children and immunological biomarkers in adults. It is, however, unlikely that SARS-CoV-2 infection is responsible for all reported symptoms in 54-65% of CYP in our cohort. Whilst some symptoms, such as loss of taste or smell, are strongly associated with SARS-CoV-2 infection, these improve with time, while most of the other reported symptoms are non-specific and often commonly reported in adolescents, even before the current pandemic. (Pereira et al. 2024)

Biopsychosocial Intent

These biopsychosocial studies present complexities beyond simple physical/psychological distinctions. It is a maelstrom of influences and factors that allows them to have their cake and eat it. They can affirm its biological ‘reality’ while also allowing enough room for doubt and enabling Long Covid to be under the psychological medicine discipline.

Peanuts cartoon by Charles M Schultz

The study’s poor design is, conveniently, the point. It plays into their hands, as they can imply that declining mental and physical health of children is nothing to do with having Covid and they all need to have biopsychosocial intervention. Slam dunk! This abnormal psychology is continually reinforced:

Nonetheless, CYP reporting symptoms at 24 months follow-up, irrespective of their SARS- CoV-2 infection status, were more likely to have poorer self-rated concurrent physical and mental health compared to those who did not report symptoms at 24 months, highlighting a wider need for assessment and interventions to support the physical and mental health of CYP in the community during critical developmental periods, irrespective of SARS-CoV-2 infection or pandemic effects. (Pereira et al. 2024)

Somatic Symptomatology

Now, this next paragraph should instill the fear of God in everyone, yet it is not mentioned in any headlines. But, from a behavioural point of view, it is key to include this in one of the largest and highly influential paediatric Long Covid research studies. As it can influence cultural, clinical, and research narratives and agendas.

Finally, the general disruption to the lives of CYP due to the COVID-19 pandemic may contribute to somatic symptomatology, as may a chronic post-viral syndrome. (Pereira et al. 2024)

It’s nipped in amongst all the ‘good news’, yet it’s unlikely Jesus would be impressed. What is somatic symptomatology? When the DSM was updated in 2013, Michael Sharpe, Simon Wessely, and others influenced the broad reclassification of Somatic Symptom Disorder (SSD). So much so that a quarter of the population, 23%, could be seen to have this condition where abnormal psychology leads to physical symptoms. Does that prevalence seem familiar?

It does mean that the purpose of the CLoCK study is to imply that Long Covid may, notice the may, be influenced by psychological factors, thereby making it a biopsychosocial condition (not a disease) needing biopsychosocial intervention. But it’s not a definite, it’s a probably. As they can’t actually prove this. But it’s enough. The implication translates sufficiently to include it in clinical practice and global guidelines.

However: The playbook remains unchanged, crafted by the same researchers who have poisoned the well for years. Long Covid gives them another opportunity to seize a nice biopsychosocial apple and continue nurturing their ideas and careers, especially since their ground in ME has been diminished. And now the same infernal fight for territory has to be repeated in Long Covid because some people can’t admit they were wrong.

Unstable Females

Within the history of medicine, women who aren’t married, especially pubescent girls, have often been the subject of melifulous musings of medical doctors. This is visible in Marshall Hall’s work and 19th-century hysteria theories. It is expected that medicine would have evolved beyond this. Yet, the CLoCK study concludes with a dubious claim. Yes, after £1.9 million and five years into the pandemic, that Long Covid might be PMS.

Cover of Depalma's film 'Carrie' by Stephen King

We also did not examine menstruation, and some symptoms may be attributable to pre-menstrual syndrome given the high proportion of girls. (Pereira et al. 2024)

It is known that some diseases affect women more, especially autoimmune DecodeME found that:

Our findings support the assumption that ME/CFS is significantly more common in females as 83.5% of participants reported their sex assigned at birth as female. Furthermore, our data suggests that females are more likely to experience severe symptoms. This likelihood further increases with age and if they have had the condition for more than 10 years.

Because the standard human in science is often seen to be male, research commonly ignores the impact of female hormones. As they are seen as inconvenient fluctuating variables. Yet, because we do not have this knowledge about how female biology affects Long Covid and ME doesn’t mean we are confusing symptoms with PMS. Does this extrapolate to all ages of women with Long Covid?

TBH this is kind of wild. Anyone with experience of Long Covid and PMS can tell the difference, the time frame of symptoms can tell one this. The issue is that the vague questions asked by the CLoCK questionnaire and its lack of sensitivity allow this confusion.

And, strikingly, females were almost twice as likely to still meet the research definition of long Covid at 24 months, compared to males.However, the researchers note that they did not assess menstruation and some symptoms (such as headaches and tiredness) may be attributable to pre-menstrual syndrome given the high proportion of girls. (Pereira et al. 2024)

Yet, it is another way to minimise women’s illness. Research on PMT is scarce and often brushed off in medical settings as unimportant, suggesting we should simply endure it. Anyone who’s experienced PMD or regular PMT knows how life-altering it can be. That the answer to Long Covid in young women is PMT is just beyond. It’s another way to dismiss and minimise Long Covid, as we’re all just a bit confused. But it comes down to blood, to wombs, it’s hardly moved on from seeing the uterus as the source of all illness in hysterical women.

Note that this is more conjecture. It’s another ‘may’ (so common in BPS papers) so they can deny that it’s an actual claim. Uncertainty negates a finding - so omit it. But this is a game of insinuation and planting ideas - it’s not science.

Is Silence Violence?

Let’s have some good news. CLoCK’s funding only lasts till the end of 2024, so this is likely the last paper from them. But, the damage has been done. CLoCK is interlaced with the paediatric research landscape intimately, from clinical setting to other research projects. The scene has been set for a biopsychosocial framing of Long Covid in children. So, another battle has to be embarked on.

How do we do this? More good news is that there are dedicated researchers who want to explore the pathophysiology of paediatric Long Covid. But they are often denied funding and are outside the mainstream research culture.

One way we can do this is to not maintain a veneer of silence. We can observe the lessons of what has happened in ME research, especially as some of the researchers in CLoCK have been active in this field. The NICE guidelines change and the paradigm shift that is in process didn't happen through silence or cooperative association with the researchers. It happened through a clear delineation of the problems and TBH it was (and is) quite a bun fight.

Doing PPI (Public Patient Involvement) with these types of studies is not going to work. The researchers are too set in their ways. There is the danger of tokenism and a lack of independence. Social dynamics between researchers and advocates can significantly hinder PPI; personal connections often lead to pressure against public criticism of study issues. We have seen this time and again in the Long Covid sphere.

It is from the ME community, especially Dr David Tuller and Prof Brian Hughes, that a more rigorous and independent critique is coming against the problematic research in Long Covid. We see this for REGAIN, ReCOVer and the latest Systemic Review that recommended CBT and exercise.

Long Covid orgs and charities need to be able to open a space compassionately so we can bring to light serious research problems, as our first priority is to the safety of people with Long Covid. This means that the community and especially parents need to be aware of any issues to be able to make informed decisions. We’ve been pretty lonely as an Org, in our commitment to do this. Although credit must go to The Sick Times, for its unswerving determination in covering all issues, including the gnarly ones.

Public comment often steers clear of certain subjects in Long Covid to safeguard relationships with researchers who provide access to higher levels of power and authority in the research domain.

Yet, if we are silent to placate and not upset those in power, we have to ask is our silence violence? And who benefits from our silence?

State Violence

There is also the lack of urgency and dismissal of the need for biological research in paediatrics. The research infrastructure silence on funding impactful child and youth studies, five pandemic years later, can be seen to constitute structural violence towards children. As does the refusal to instigate clean air in schools.

One of the main takeaways from the CLoCK study is that children with Long Covid have been left without effective medical treatments or interventions. They have just been observed during this longitudinal study.

This refusal to engage practically, implying that there are psychological factors influencing paediatric Long Covid, has led to a silencing and injustice for families. Children are often not believed in schools or within friendship and family groups. Obtaining safe support, protection from Covid and the time to rest in education can be difficult. These headlines matter. Narrative matters. This is the true failure of the CLoCK study; that in its spin internationally, it fails to convey the realistic impact and devastation of Long Covid on a young child’s life. We are left with the sense that we can be reassured and don’t need to change anything as most get better. Yet, how can children and young people recover without medical care?

At the extreme end, we are enabling state violence as more and more families experience inappropriate social services intervention. Because professionals assume parents are to blame. This causes lifelong trauma and a disastrous relationship with the medical profession when children need it the most. To suit capital needs and the convenience of not having to engage, there is an accepted violence towards children through the lack of protection and public health messaging.

This has led to devastating impact from the ongoing pandemic, for children and young people suffering from Long Covid and the secondary impact of community transmission from schools. How many families have had their lives ravaged through the powerful vector education creates - not just from Covid, but from other airborne illnesses such of Flu and RSV? It is not good news. It is a clear and present danger.

We need courageous and compassionate state intervention: prioritising clean air in schools and public spaces; ring-fenced immediate research funding to investigate biomarkers, pathophysiology and effective treatments for paediatrics; inclusive SEND support; urgent updating of medical education and a direct public health campaign so families are aware of the risks they run with every school day.

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