What kinds of research are going on?

Lots of different trials are going on across the country, these might be;

• Trials collecting information during and after coronavirus infection.

or

• Trials in which people with coronavirus can receive one or more treatments that might help to fight the infection.

or

• Trials of vaccinations to stop people from getting the infection. These are usually tested on people who have not had the virus, unlike you, so we will not discuss these trials here.

 

Trials collecting information

Research trials in which samples (like blood tests) or information are collected at different times, without giving any medicine, are called observational trials.

International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) is a very large trial running across the country, looking at which factors might make people more at risk from coronavirus infection, like age or race.

Studying the disease in a large number of people means that the results are more likely to be reliable.

You might have been asked to give blood samples as part of this trial, or to let the research team look at your medical records to collect information about your symptoms and background health.

Other clinicians and scientists want to understand in detail the way that the virus affects our bodies at the time of infection. You might have been asked to have special tests to help with this.

There are other national trials collecting information about coronavirus infection in more specific groups, including pregnant women and new born babies.

Now that lots of people are recovering from coronavirus infection it is important to understand whether the virus has any longer term effects on people’s health. Another group of trials will focus on collecting information about this.

 

Treatment trials

Another type of research trial in which a medicine or treatment is used against the virus is called an interventional trial.

To choose a medicine or treatment we need to have a good reason to think it might work based on scientists studying the disease.

Researchers have found that coronavirus can make people ill because of;

• The direct effects of the virus on the body.
• The body’s immune system over-reacting. When this happens, lots of inflammatory chemicals are produced to fight the virus, but these can have some harmful effects like making the lungs wet, or the blood sticky and more likely to clot.

Some medicines that are tested will target the virus, while some will target our body’s immune response.

When we think we have a medicine that might work, we also need to be able to compare it to what we already do to treat the infection, to make sure it gives an added benefit. This includes giving extra oxygen to those with low oxygen levels, a fluid drip to people who are dehydrated, paracetamol for a high temperature and, in some cases, the steroid dexamethasone with or without the anti-viral medicine Remdesivir.

If research trials show that a medicine can be given safely and definitely helps, everyone would have the chance to receive this, even if they are taking part in another trial.

 

What are the bigger studies that are happening in the UK?

The largest trial to find medicine to treat coronavirus infection is the Recovery trial. This is being run in 176 hospitals across the UK with more than 12,000 people having taken part so far.

People like you with definite or suspected coronavirus infection are randomly assigned to different medicines used to treat other health conditions, like chest infections or arthritis. At some hospitals, you could also receive a type of blood transfusion.

Some of the medicines are tablets and others are injections.

The medicines being tested in this trial are:

• An antibiotic with extra effects on top of treating bacteria.
• An anti-inflammatory injection.
• Convalescent plasma.

Specific medicines that target inflammation are being tested in a number of other trials around the country, like the one in the Recovery trial.

These are called ‘biologic’ agents because they are similar to chemicals in our immune system. Some are already being used for health problems like arthritis or heart disease, whilst some were still in the testing phase when the pandemic hit. Scientists have often spent many years developing these medicines and think that the way they work means they will be really useful to treat coronavirus infection.

 

Are there different trials for people with more severe infection?

People with more severe coronavirus infection might need treatment on the Intensive Care Unit (ICU). One large ICU trial is the REMAP-CAP trial. Patients can receive combinations of different kinds of medicine in this national trial including:

• A corticosteroid (commonly used to reduce inflammation).
• An antibiotic with extra effects on top of treating bacteria.
• A drug acting directly on the virus.
• A drug that affects the body’s immune response.
• An injection to keep the blood thin and prevent clots.
• Treatment with high dose vitamin C
• A convalescent plasma drip.

The people on ICU are the most severely affected by the virus, so there are other trials offering small numbers of people stem cell treatment to help the lungs repair.

 

What is convalescent plasma?

This is offered in both the Recovery and REMAP-CAP trials. It is a type of blood transfusion, and involves giving a part of the blood donated by people like you who have now recovered from coronavirus infection.

Plasma contains antibodies that might help to fight off the infection.

 

What about trials of treatments that aren’t medicines?

Other treatments used to treat coronavirus infection include things like oxygen. Oxygen can be delivered to a patient’s lungs in different ways, including through a normal face mask or through a tight-fitting mask called CPAP.

CPAP stands for continuous positive airways pressure, and is a type of breathing support. A bedside machine blows oxygen and air into the lungs through a tube at high pressure to stop the lungs from getting wet and collapsing.

The Recovery-RS trial compares these two ways of giving people oxygen.

In a similar way, doctors on ICU are running trials to find out the best way to use a ventilator to help peoples’ lungs recover.

 

Why wasn’t I asked to take part in this research when I was in hospital?

There are a few reasons why you might not have been offered some of the trials mentioned on this website.

Some of the trials will only include people who meet certain criteria, for example, you would not be offered a medicine that might make any of your background health conditions worse.

Another reason is that a hospital can only offer a few trials at the same time because there is a lot of organisation that has to happen behind the scenes for a trial to work well. New research trials are starting all the time, so some trials might not have started when you were in hospital.

Finally, some of the trials change to keep up-to-date. Trials that can change over time are called adaptive trials. When a trial changes it can be quite confusing but the research team can always be contacted to help explain any questions that you or family members and friends might have.

 

Are there any results so far?

Trials of the anti-viral drug Remdesivir started in March 2020, and showed that this might help people to recover from coronavirus illness. This is now available in the UK for unwell patients. Unfortunately there are limited supplies so this cannot be given to people with mild illness.

Trials have suggested that some medicines might cause side effects, like the anti-malarial medicine, hydroxychloroquine. When information like this comes to light it is really important to closely examine the research trials to make sure that the information is accurate.

Often information is needed from bigger studies using that medicine. We know from the Recovery trial that hydroxychloroquine did not help to treat the infection so it is no longer being tested, but importantly most people who received the medicine did not have serious side effects.

The Recovery trial has also reported that using an antiviral medicine commonly used to treat HIV infection (lopinavir-ritonavir) is not effective for treating coronavirus infection, however, the commonly used steroid, dexamethasone, did help people to get better if they were seriously ill and needed oxygen or were on the intensive care unit. Dexamethasone did not help people with mild illness.

There are also promising results from a small study of beta interferon. This is a medicine used to treat some conditions of the nervous system. Breathing in beta-interferon through a nebuliser mask at an early stage of coronavirus infection might stop people from becoming more poorly. Testing it on more people will help researchers to be more certain about the effects.

If you have concerns that you have experienced side effects from a research medicine or want to find out more about this, you should contact your local research team.

 

What if I am not sure what research I have taken part in during my hospital stay?

• Coronavirus infection affects people in different ways. If the illness is mild, it would probably not stop someone from deciding whether they wanted to take part in research trials.
• On the other hand, some people might have felt too unwell to think about research when they were in hospital, or might have been sedated on the intensive care unit.
• If this is the case, the research team try to consult family members or ask the doctor looking after the patient to decide whether they think it is in that person’s best interests to take part in research.
• Once people recover and are well enough to understand what has happened, either in the hospital or back at home, the research team make contact to explain what has happened, and make sure the patient is happy for information to be collected about their recovery.
• If you think that you have been involved in a research trial but are not sure of the details, you can contact the research team at your hospital for more information.
• If you are not happy about the way you have been treated by the research team, you can contact them directly to discuss this too. If you do not feel comfortable doing this, you can raise your concerns with the complaints team at your local hospital. Contact information for both the research team and the complaints team can usually be found on the hospital’s website or through the hospital switchboard telephone number.

 

What research trials could I be asked to take part in after going home from hospital?

Coronavirus infection affects people in different ways. You might feel completely back to normal, or you might still have some symptoms, for example, shortness of breath or tiredness. Because coronavirus is a new infection, we don’t really know how long symptoms like these might go on for, or why they affect some people but not others.

This means it is really important to check on you after you have been ill, to collect information about the longer term effects of coronavirus infection on physical and mental health. Many hospitals are inviting people, like yourself, to take part in follow-up studies for this reason.

One large, follow up study that you might be invited to take part in is called PHOSP-COVID. This study will collect information from 10,000 people across the country who needed to be admitted to hospital because of coronavirus infection. You can be involved in this trial in different ways. You can simply let researchers find out about your background health, illness and recovery from your medical records, along with giving a saliva sample for DNA testing, using a kit that is sent to you in the post. If you have more time, you might agree to complete a set of special tests, for example blood tests and walking tests, at different time points after you go home from hospital.

Some hospitals will run their own follow up studies that collect other kinds of useful information.

Lots of people have taken part in a medicine trial, like the Recovery trial, when they were in hospital. If you would like to take part in a follow up trial as well, this is usually fine, but let your research team know which trials you are taking part in and they can check for you.

 

Is there anything I can do to help?

You might already be taking part in a research trial or decide that you would like to take part in a follow up trial. Clinicians and scientists are so grateful to you for this, as it is the only way to learn more about treating coronavirus. This information will help many more people in the future.

If you are keen to do more, then you can talk to your friends, family and colleagues about your positive experiences taking part in research, as this may encourage other people to do the same in future.

If you feel that you want to do even more to help, some people who have fully recovered from coronavirus infection are able to donate blood with antibodies in (convalescent plasma) which can be used in the research trials mentioned above to treat people who are ill. You can find out more about this process by going to the NHS National Blood and Transplant website.