An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.

COVID-19 Clinical Trial

— ERASE-LC  

Official title:

An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911906
• Other study ID #: UoD/ERASE-LC/23
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: July 22, 2025

Study information

• Verified date: May 2024
• Source: University of Derby
• Contact: Mark Faghy, PhD
• Phone: 01332592109
• Email: m.faghy[@]derby.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: July 22, 2025
• Est. primary completion date: July 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• Has the use of a smart phone.
• Evidence of persistent symptom profile relative to pre-COVID-19 status as derived from patient reported outcome measures.
• 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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Derby	Derby
United Kingdom	University of Exeter	Exeter

Sponsors (4)

Lead Sponsor	Collaborator
University of Derby	Peninsula Clinical Trials Unit, University Hospitals of Derby and Burton NHS Foundation Trust, University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	53 days
Primary	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):	53 days
Primary	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
Primary	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).	53 days
Primary	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.	53 days
Primary	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).	53 days
Secondary	To identify the most clinically relevant primary outcome for the definitive study	Quality of life, functional status and symptom burden (Pre and Post Intervention Patient Reported Outcome Measures)	52 days
Secondary	To identify the most clinically relevant primary outcome for the definitive study	Tolerance to physical stimulus: exercise tolerance and reduced post exertional symptom exacerbation following incremental exercise.	52 days
Secondary	To identify the most clinically relevant primary outcome for the definitive study	Physiological function, physical function, cognitive function, and emotional status and/or capacity.	52 days
Secondary	To identify the most clinically relevant primary outcome for the definitive study	Biomarker and inflammatory profiles	52 days
Secondary	To identify the most clinically relevant primary outcome for the definitive study	Exeter patients only - Microvascular function: whole body FDG uptake using PET/CT methods.	53 days
Secondary	To determine the clinical safety and tolerance parameters of the use of Remdesivir in the treatment of patients with Long COVID.	AE/SAE/AR/SAR/SUSAR	53 days