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 lastfor months and even years. These symptoms affect people in different ways and have beendemonstrated to broadly impact physical, mental, and cognitive health. This is calledLong COVID. Currently, there are no treatments available to address the issues thatpatients experience but anti-viral medications have been suggested as being potentiallyeffective. This study will recruit patients that have confirmed long COVID andparticipants will undertake a series of tests to determine their symptoms and the impactthat their condition has had on their bodily systems. The total duration of eachparticipant's involvement is approximately 8 weeks, and this will involve 13 visits (15visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initialassessments are conducted over three separate visits and then all participants will bescheduled to receive five consecutive days of a medication that has been identified ashaving the potential to reduce the impact of Long COVID. Following a period of 28 days,participants will be invited to repeat the same tests that were conducted beforereceiving the medication so that it can be determined how well the drug has worked. Inthis study we are specifically collecting information to understand how feasible thismedication could be to help patients improve their condition and this will help us todetermine how likely this drug is able to be used within the wider Long COVID community.The medication that will be used within this study is an existing anti-viral medication(Remdesivir). If we find patients are able to tolerate the treatment and the researchtasks we will use this information to conduct a larger trial to determine how well thisdrug can be used to reduce the impact of Long COVID in a greater number of patients.
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. Currently, there are
no treatments available to address the issues that patients experience but anti-viral
medications have been suggested as being potentially effective. This study will recruit
patients that have a confirmed long COVID diagnosis and 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 approximately 8
weeks, and this will involve 11 visits (13 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 a
medication that has been identified as having the potential to reduce the impact of Long
COVID. 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. In this study we are specifically collecting information to understand how
feasible this medication could be to help patients improve their condition and this will help
us to determine how likely this drug is able to be used within the wider Long COVID
community.
The medication that will be used within this study is an existing anti-viral medication
(Remdesivir) and if this is possible, we 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.
Drug: Remdesivir
Remdesivir is a prodrug that is intended to allow intracellular delivery of GS-441524
monophosphate and subsequent biotransformation into GS-441524 triphosphate, a
ribonucleotide analogue inhibitor of viral RNA polymerase.
Participants will receive a single loading dose of 200 milligrams of Remdesivir in 250ml
sodium chloride 0.9% bag via IV over 60 minutes on day 1, followed by, on days 2 - 5, a
dose of 100 milligrams of Remdesivir in 250ml sodium chloride 0.9% bag via IV once daily
over 30 minutes.
Other Name: Veklury,PRD8099279
Inclusion Criteria:
- ≥18 years of age at the time of enrolment
- Previously confirmed or suspected SARS-CoV-2 infection
- Confirmed diagnosis of Long COVID by a Health Care Practitioner according to the
*definition provided by the World Health Organisation for persistent symptoms
following a confirmed SARS-CoV-2 infection.
- Willing and able to provide informed consent, complete the surveys, and complete all
planned clinical assessments, and return for scheduled study visits.
- Evidence of persistent symptom profile relative to pre-COVID-19 status as derived
from patient reported outcome measures.
- Lives within commutable distance of the relevant centre, at discretion of local
Principal Investigator.
- WHO define Long COVID as the continuation or development of new symptoms 3
months after the initial SARS-CoV-2 infection, with these symptoms lasting for
at least 2 months with no other explanation.
Exclusion Criteria:
- Treatment history of Remdesivir, molnupiravir, paxlovid and/or any other COVID-19
anti-viral medication (<6 months).
- A diagnosis of a compromised immune system or function from a Healthcare
Professional.
- Currently engaged in a physical rehabilitation programme or intervention aimed to
improve Long COVID symptom profile and/or functional status.
- Recognised as a 'severe risk' of experiencing post-exertional malaise following
engagement in physical tasks. Determined using the Modified De Paul Symptom
Questionnaire.
- Lack of mental capacity to provide informed consent.
- Unable to understand verbal English/have a hearing impairment that prevents adequate
communication.*
- Participation in another clinical drugs trial within the last 6 months
- Currently pregnant, breastfeeding or attempting to get pregnant (i.e., not using
effective methods of contraception).
- 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/
- History of serious adverse reactions to anti-viral medication and intravenous
infusions
- History of Hepatic or Renal Impairment (eGFR (<30ml/min) and LFTs ALT>x5 ULN).
- 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:
- 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 in languages other than English.
- 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.
Derbyshire Community Health Services NHS Foundation Trust
Chesterfield, United Kingdom
Royal Derby Hospital (UHDB)
Derby, United Kingdom
University of Derby
Derby, United Kingdom
University of Exeter / Royal Devon University Healthcare NHS FT
Exeter, United Kingdom
Mark Faghy, PhD
0133 259 2109
m.faghy@derby.ac.uk
Kayle-Anne Sands
erase.penctu@plymouth.ac.uk
Victoria Allgar, PhD, Study Chair
Pen CTU