An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.
ERASE-LC
1 other identifier
interventional
73
1 country
4
Brief Summary
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. This study will recruit patients that have confirmed long COVID 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 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 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). If we find patients are able to tolerate the treatment and the research tasks 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2024
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2025
CompletedFebruary 20, 2026
February 1, 2026
11 months
June 20, 2023
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
To ascertain screening and recruitment rates (overall and by different recruitment pathways).
55 days
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
Retention and dropout rate (due to the treatment and/or trial demands, overall and by centre):
55 days
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
Adherence to treatment regimen (attendance to 5 days of IMP).
22 days
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
Completeness of study assessments (CPET, Bloods and PET/CT if in Exeter).
55 days
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
Completeness of all data collection activities including baseline and +28 days after treatment.
55 days
To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
Acceptability of outcome measurements (measured by completion rates).
55 days
Secondary Outcomes (6)
To identify the most clinically relevant primary outcome for the definitive study
52 days
To identify the most clinically relevant primary outcome for the definitive study
52 days
To identify the most clinically relevant primary outcome for the definitive study
52 days
To identify the most clinically relevant primary outcome for the definitive study
52 days
To identify the most clinically relevant primary outcome for the definitive study
55 days
- +1 more secondary outcomes
Study Arms (1)
Treatment Group
EXPERIMENTALFive days of Remdesivir infusion delivered by IV.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Derbylead
- University of Exetercollaborator
- University of Plymouthcollaborator
- University Hospitals of Derby and Burton NHS Foundation Trustcollaborator
- Aston Universitycollaborator
- Royal Devon and Exeter NHS Foundation Trustcollaborator
Study Sites (4)
University of Derby
Derby, Derby, DE22 1GB, United Kingdom
Derbyshire Community Health Services NHS Foundation Trust
Chesterfield, S42 7JE, United Kingdom
Royal Derby Hospital (UHDB)
Derby, D22 3NE, United Kingdom
University of Exeter / Royal Devon University Healthcare NHS FT
Exeter, EX4 4PY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Victoria Allgar, PhD
Pen CTU
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label.
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Clinical Exercise Physiology
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 22, 2023
Study Start
October 8, 2024
Primary Completion
September 17, 2025
Study Completion
September 17, 2025
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
The PenCTU data team will have access to the trial dataset, including identifiable participant data. Other members of the CTU and the wider study team will have restricted access to pseudo-anonymised study data. Access to the dataset will be granted to the Sponsor and host institution on request, to permit study-related monitoring, audits and inspections. Access will be overseen by the CTU data manager and trial manager. Access to the final dataset will be provided to the trial statisticians for analysis. After the trial has been reported, the anonymised individual participant data that underlie the results will be available on request from the CI and Sponsor, along with supplementary files as required (e.g., data dictionaries, blank data collection forms, analysis code, etc). Data will be shared with (or access to the data will be provided to) requestors whose proposed use of the data has been approved by the CI and Sponsor, under an appropriate data-sharing agreement.