Frequently Asked Questions
Is the study still recruiting patients?
As of 1 August 2024 we are no longer recruiting patients to the trial.
Am I eligible for the STIMULATE-ICP study?
In sites where we are recruiting, people who are over the age of 18 years, able to give consent to participate in the study and having persistent symptoms for 4 weeks or more after COVID-19 illness may be eligible for STIMULATE-ICP. Those who are eligible will be asked by their health professionals and our study team if they want to join the study.
How can I be referred to the trial?
We cannot accept self-referrals into the trial because we are recruiting from certain clinics in certain geographic areas. This is so that we can study the care of Long COVID at system level in those areas. We are recruiting from existing Long COVID clinics. Please contact your GP regarding referral to your nearest Long Covid clinic. Please get in touch if you are unsure whether you are within the catchment of one of STIMULATE's participating clinics: info@stimulate-icp.org
What is it like to be a trial participant?
Our patient advisor, Mag, talks through her own experience of participating in the trial and gives an idea of what you can expect if you take part: https://youtu.be/WEcAUO7meaY
Why did the study initially only focus on people with new long COVID?
The study is looking at the best pathway for people with long COVID. Therefore, in order to answer this research question, initially we recruited people with new long COVID who had been referred to the NHS Long COVID clinic services and had not yet been seen by specialist services. Now we have a better understanding of which is the best clinical pathway to treat long COVID, we are opening the drug trial to people with long COVID, regardless of when their long COVID started and whether they have previously sought treatment in long COVID services.
Which drugs will be tested?
The independent advisory panels have now agreed that our choice of drugs is the right choice to start with. We will be testing: Famotidine and Loratidine (antihistamines) in combination, Rivaroxaban (an anti-clotting drug) and Colchicine (an anti-inflammatory drug).
Why have these drugs been chosen?
Long COVID is a new disease and the underlying mechanisms are still being investigated and understood. Therefore, we do not yet know which drugs will work. That is why we need to do trials to assess whether these drugs are useful and effective for patients. First, the drugs we have chosen are widely available and some health professionals and patients have reported that they may be useful. Second, there is a plausible mechanism by which these drugs might work in long COVID. Third, these drugs are already available for use in other conditions, and so could be relatively easily “repurposed” at scale to treat long COVID, if they were shown to be effective in a trial.
Famotidine/Loratidine: Patients with long COVID may have persistent inflammation, which is related to “mast cell activation” and release of histamine. Famotidine and loratadine are histamine receptor blockers which are commonly used to treat mast-cell activation in other conditions. In long COVID, antihistamines have been of benefit in some patients.
Rivaroxaban: People with long COVID may have “micro-clots” in their circulation. These clots could reduce oxygen reaching large muscles during exercise, possibly explaining the “post-exertional malaise” which people with long COVID often describe. There are increasing reports from patients and their health professionals of success of therapy with anti-clotting drugs such as rivaroxaban.
Colchicine: In some patients with long COVID, there is inflammation around the lining of the heart (“pericarditis”) and lungs (“pleuritis”). Colchicine is an anti-inflammatory drug which has benefit in pericarditis. Given the high proportion of people with long COVID who have chest pain and breathlessness, pericarditis and pleuritis are likely to be common, and colchicine may be of benefit.
There is potentially scope for other drugs to be added to the trial platform via the COVID Therapeutic Taskforce.
Why do we need to do trials of these drugs?
There is not clear evidence as to whether these drugs are useful and effective for people with long COVID. The best way to find out if drugs are effective is to do proper clinical trials. Otherwise, we may be using drugs which are not effective or may cause harm. In clinical trials, people are randomly allocated to drugs or not and then followed up over time by researchers. The effects in people in different treatment groups are compared at the end of the trial. It is better to wait for the results of a properly conducted trial before starting a treatment.
Should I ask my doctor/pharmacist for these drugs?
No, not as part of routine care and only as part of a clinical trial like STIMULATE-ICP. For drugs which are not currently supported by trial evidence or in clinical guidelines, the drugs are to be used at the discretion of your health professional. As described above, we would recommend waiting until the trial shows that the drugs are effective before asking for them.
Other than drugs, what else is being tested in the STIMULATE-ICP trial?
This is a complex study which is testing components of an “integrated care pathway”- investigations, drugs and rehabilitation approaches. In a cluster-randomised design, primary care networks (the “clusters”) will be randomly allocated to provision of CoverscanTM (a multi-organ MRI scan to rule out organ impairment) prior to long COVID clinic appointment and/or to a digital enhanced rehabilitation programme (Living with COVID RecoveryTM). These new interventions will be compared with usual investigations and usual rehabilitation in order to assess whether they are useful and effective in clinical care of people with long COVID. In a nested drug trial, at the long COVID clinic, individuals will be asked if they want to take part in the drug trial. If they give consent, they will be randomised to one of the drugs under study, or no drugs.
Why was there a delay in starting the trial?
The funding decision was made and announced in July 2021. It took time for independent advisory panels, appointed by the UK Government’s Therapeutic Taskforce, to ensure that the drugs we test in the STIMULATE-ICP are the right drugs to test. Once the choice of drugs was made in November 2021, we applied for ethical approval in December 2021, after updating our documentation and checking with our researchers, our clinicians, and most importantly, our patient team members.
Ethical Approval
The trial has been granted full ethical approval by the MHRA (Medicines and Healthcare products Regulatory Agency) and HRA (Health Research Authority). Other than the drug trial part of STIMULATE-ICP, we have started the other components of research, such as evaluation of current care and assessment of inequalities in how long COVID presents and how it is being treated.
Where can I find further support for living with Long Covid?
Please see online support tool developed by the STIMULATE team at University of Southampton, which offers a symptom checker, advice on seeking support, and encourages people to talk about their symptoms with professionals, friends and family: https://long-covid-care.org.uk/
I have further questions. Who should I contact?
Please check the study website, particularly the study details and resources pages and if your question is not answered, then contact us at info@stimulate-icp.org
