[Recruiting] COVID-19 Human Challenge Study: COVHIC002 (Imperial College)

Documents timestamped at 14th Oct 2022
Quarantine 1&2 of 5 full, set to begin 15th March 2023 and 14th April 2023

https://www.imperial.ac.uk/infectious-disease/research/human-challenge/covhic002/

Recruiting Now
We are looking for healthy volunteers aged 18-30 years old to take part in a new COVID-19 Human Challenge Study.

The study involves a screening visit, a quarantine stay, during which you will be deliberately infected with the COVID-19 virus and carefully monitored until discharge, followed by five follow-up visits over the course of 12 months.

If you are eligible to take part, you will be paid up to £4,470 for time and inconvenience.

If you are interested in finding out more, please read the full study information sheet (COVHIC002 Participant Information Sheet) and register your interest by completing our pre-screening questionnaire.

The patient information sheet for qualifying informed consent includes the following (my bold) —

• If you take part in this study, you will be given SARS-CoV-2 virus (the cause of COVID-19 disease) as drops in the nose.
  
  
• You may develop COVID-19 symptoms, including tiredness, loss of smell and/or taste, cough and fever. These should get better by the time you leave quarantine but some may go on for weeks or more.
  
  
• If you need for your sense of smell to remain completely normal, you should not enter this study.
  
  
• There is a very small risk that you could become more seriously unwell if you develop COVID-19, but this is extremely rare in young, vaccinated people. We will go through these risks with you in detail (see Section 3.1).
  
  
• You will need to stay in an en-suite room in a designated quarantine unit staffed by clinical study staff with no visitors for (on average) 17 days but may be discharged earlier after 13 days if you are not infectious or later if you are still infectious.
  
  
• During quarantine, you will be closely monitored for any symptoms. If these get worse above a certain level, you may be given medicine to treat the infection. If you become unwell with COVID-19 and require more specialist care, you will be transferred to the local NHS hospital.
  
  
• If you experience more severe or longer-lasting symptoms, you will be provided with care by medical specialists and can claim on our insurance in case there are any long-term problems.

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3.1.2 What is the risk of “long COVID”?

In most cases, symptoms in younger adults get better within 3 weeks. However, some people have longer-term symptoms that can last months before getting better. This is sometimes called “long COVID” and is more common in older women who have a larger number of symptoms. The risk of long COVID is very much reduced in vaccinated people. The most common long-lasting symptoms are:

o Tiredness
o Breathlessness
o Palpitations (racing heart)
o Chest pains
o Joint or muscle pain
o Not being able to think straight or focus (“brain fog”)
o Loss or change in smell/taste.

In most cases, these changes go away after a few months and there are some treatments that may reduce them, but it is still not completely clear exactly how long these symptoms can last for and how many people they might affect.

As an adult aged 18-30, your risk of long COVID is low: after natural infection in unvaccinated people, around 1 in 100 people aged 18-30 still have some symptoms (most commonly tiredness and loss of smell) after 8-12 weeks. These are usually mild and after the earlier SARS-CoV-2 human challenge study the only longer-lasting symptom was reduced sense of smell, but we will monitor you for long COVID during the follow-up visits. However, if you have drawn out symptoms, we will refer to you specialists to give you treatment and help you recover more quickly if possible.

People who have been vaccinated against COVID-19 are relatively protected against developing long COVID. The ZOE Covid Symptom study showed that a full course of COVID- 19 vaccination halves the risk of symptoms continuing beyond 4 weeks.

It is also important to note that long-lasting symptoms aren’t unique to COVID-19 and can occur after other viral illnesses.

 

This study is on very shaky ethical grounds, hence the monetary enticement, which is in itself, an ethical violation of human research subjects' rights.

 

you will be deliberately infected with the COVID-19 virus

Utterly appalling.

Are they going to take full responsibility for any adverse consequences, including financial costs of lifelong disability, if it goes wrong?

Or are they just going to blame the patient for not wanting to get better?

 

This is a repeat of their first investigation (original strain) Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults (2022, Nature Medicine).

The study virus in question is the delta variant, which as far as I know has only existed in research labs for the last 12 months+.

 

With a risk of Long Covid, £4,470 would only cover the cost of first few months of a potentially life long disability.

Though someone like my goddaughter who has had Covid-19 four times now might feel the risks of any long term issues is minimal I would strongly discourage anyone I knew from taking part.

 

WHO International Guidelines for Biomedical Research in Human Subjects:

Guideline 4, Risk/Benefit:

https://www.who.int/docs/default-source/ethics/web-cioms-ethicalguidelines.pdf?sfvrsn=f62ee074_0

The study's risk (no benefit other than the monetary enticement) patient info pdf prior to consent:
https://www.imperial.ac.uk/media/im...e/COVHIC002_Participant_Information_Sheet.pdf

 

Nope. You won't. Promising that is just dishonorable, they *know* there is no treatment, deep down at least, behind the thick hopium smoke. They say this because they still believe it's trivial and always goes away, it's a BS legal disclaimer. They say there are treatments and that they will help you recover more quickly. This is another lie. They don't know how to do that, they just pretend to. Which is why everything is all broken.

If you become disabled, there will be no help for you. This is a lie, they are making false promises that they can't back up. It likely won't happen, but for those to whom it happens, they will not be of any help, they will in fact gaslight you about it. Just like they do with everyone.

 

"As an adult aged 18-30, your risk of long COVID is low: after natural infection in unvaccinated people, around 1 in 100 people aged 18-30 still have some symptoms (most commonly tiredness and loss of smell) after 8-12 weeks."

Is there a reference for this? Seems to be completely wrong as a claim.