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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Mark Faghy
+44 (0)1332 592109
m.faghy@derby.ac.uk


Ms Kayle Sands
-
kayle-anne.sands@plymouth.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Are anti-viral medications (remdesivir) a safe and feasible drug to improve outcomes for those living with Long COVID?
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Are anti-viral medications (remdesivir) a safe and feasible drug to improve outcomes for those living with Long COVID?

Recruiting

Open to: All Genders

Age: Adult

Derby Derby Exeter Ashgate

Medical Conditions

Post COVID-19 condition, post COVID syndrome and/or Long COVID

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental, and cognitive health. This is called Long COVID. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. The medication that will be used in this study is an existing anti-viral medication (remdesivir). In this study the researchers are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help to determine how likely this drug is able to be used within the wider Long COVID community.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

23 Sep 2024 23 Sep 2025

Participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant’s involvement is about 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of remdesivir. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked.


Patients aged 18 years and over with long COVID

You can take part if:



You may not be able to take part if:


1. Treatment history of remdesivir, molnupiravir, paxlovid and/or any other COVID-19 antiviral medication (<6 months)2. A diagnosis of a compromised immune system or function from a healthcare professional3. Currently engaged in a physical rehabilitation programme or intervention aimed to improve Long COVID symptom profile and/or functional status4. Recognised as a ‘severe risk’ of experiencing post-exertional malaise following engagement in physical tasks. Determined using the De Paul symptom questionnaire5. Lack of mental capacity to provide informed consent6. Unable to understand verbal English/have a hearing impairment that prevents adequate communication* 7. Participation in another clinical drug trial within the last 6 months 8. Currently pregnant, breastfeeding or attempting to get pregnant (i.e., not using effective methods of contraception)9. Currently taking medications known to have an interaction with Remdesivir (e.g., chloroquine phosphate or hydroxychloroquine) as defined by British National Formulary (BNF) information on the selection, prescribing, dispensing and administration of medicines: https://bnf.nice.org.uk/interactions/remdesivir/10. History of adverse reactions to anti-viral medication and intravenous/infusions11. History of hepatic or renal impairment (eGFR <30 ml/min and LFTs ALT > x5 ULN)12. Exeter participants only: no recent/long-standing history of CT (within 3 months)/ongoing radiotherapy treatment. Risks of accumulative burden to be discussed as part of study involvement but it is at the discretion of participants.

*Note:1. English comprehension: potential participants who are unable to understand verbal English will not be eligible for this study. This is due to the necessity of telephone contact which is a key aspect of this study and the unavailability of validated questionnaires other than English. 2. Hearing impairment: unfortunately, if the participant has a hearing impairment that prevents adequate communication on the telephone, they will not be able to take part in the study. This will be clearly stated in the participant information sheet.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Derby (Testing Centre)
    Kedleston Road
    Derby
    DE22 1GB
  • University Hospitals of Derby & Burton NHS Foundation Trust (Treatment Centre)
    Uttoxeter Road
    Derby
    DE22 3NE
  • University of Exeter / Royal Devon University Healthcare NHS Foundation Trust (Testing/Treatment Centre)
    Level 1 Bowmoor House Royal Devon and Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Derbyshire Community Healthcare Services (Participant Identification Centre)
    Ashgreen Learning Disability Centre Ashgate Road
    Ashgate
    S42 7JE

If patients are able to tolerate the treatment and the research tasks the researchers will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.
The use of remdesivir carries no higher risk to patients than when used in standard medical care. In addition, there is an established safety profile for Remdesivir administered at 100 mg (preceded by a 200 mg loading dose) via intravenous infusion for up to 10 days, which exceeds the treatment duration outlined by the current study (5 days total). Therefore, the risk for the current treatment protocol can be considered low.
Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration of remdesivir. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. Patients will be monitored for hypersensitivity reactions during and following administration of Remdesivir. Remdesivir will be discontinued if any occur and appropriate treatment is initiated. Participants will be screened to determine previous history of adverse reactions (ARs) to infusions/medicines during the initial screening process details of which will be shared with the study’s clinical team to make the final decision about suitability to be recruited to the study. During the administration period, patients will be monitored by appropriate staff members and any ARs will be reported to the sponsor immediately and the appropriate documentation completed and shared with the appropriate study/ regulatory partners. Dosing and infusion rates have been discussed and agreed in line with the SmPC and the study’s principal investigators who are medically trained and have clinical experience of using this IMP in acute settings.
Increased Transaminase elevations are listed as a common adverse event in the SmPC, therefore liver function will be tested prior to study enrolment and monitored at day 27 for safety purposes.
To negate any renal toxicity, all patients will have eGFR screened at the detailed screening visit and on Day 27 to determine suitability for participation.
There is a risk of reduced antiviral activity when co-administered with chloroquine or hydroxychloroquine. Patients who are taking either of these medications will be excluded from the study. We cannot guarantee participants will experience any benefits from taking part in this study as we do not know what the results will be, which is why we are carrying out this research. However, participation will contribute to the development of new knowledge and understanding of Long COVID and potential treatments, which could help improve the care of people with Long COVID in the future.
COVID-19 is a threat to these patients therefore mitigation of transmission at each site will be achieved by encouraging all research staff and participants to complete lateral flow tests in the event of experiencing COVID-19 symptoms. FFP3 masks will be provided at each site for all research/clinical staff and participants. Where spaces do not have windows and adequate ventilation the use of a high-efficiency particulate absorbing (HEPA) filter is mandatory and will be provided by the study. All equipment and facilities should employ cleaning and sterilising procedures before and after each session using locally approved cleaning products. This also includes participants and research staff using hand sanitiser as they enter and leave designated research spaces.
There is a risk of post-exertional symptom exacerbation and post-exertional malaise following completion of the CPET protocol. It has been developed with rigorous testing and piloting and has demonstrated tolerability within Long COVID patients as part of a research project (IRAS ID: 313936). This study now completed (December 2023) and there has been only one reported adverse event (AE) in any data collection sites (two internationally, three nationally) and over 175 tests. The outcome of the AE was unrelated. To ensure safety a strict inclusion criterion will support recruitment to the study. This excludes participation from those determined (through screening) to be at serious risk of experiencing post-exertional malaise.
Patients with Long COVID are at risk of fatigue and severe exacerbation of their symptoms if too much physical, emotional and cognitive stress is exerted. The following actions are in place; parking adjacent to the testing and treatment rooms, wheelchairs available, minimum noise levels, reduced distractions, low-level lighting in testing and treatment rooms where possible, rest periods provided between periods of talking. Participants will be asked to complete a series of questionnaires. To limit fatigue these will be provided 24 hours in advance. Additional consideration will also be given to patients with Postural Tachycardia Syndrome (PoTS). Symptoms include dizziness, heart palpitations, and shortness of breath. Mitigations include encouraging fluids, raising the head of the bed if the patient is lying down, and encouraging patients to get up slowly to stand and not stand too long.
Participants in Exeter will be asked to consent to have two PET/CT scans, pre and post treatment. These scans take approximately 75 minutes. Patients are not allowed to eat for 6 hours prior to the scan. This is 4 hours for people living with insulin-dependent diabetes. The actions above will be followed to mitigate fatigue and virus exposure.

Prof Mark Faghy
+44 (0)1332 592109
m.faghy@derby.ac.uk


Ms Kayle Sands
-
kayle-anne.sands@plymouth.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Derby and funded by Gilead Sciences.



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Read full details for Trial ID: ISRCTN72940450
Last updated 01 October 2024

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