Clinical trial NCT05911906: An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.
Official title: An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: Long COVID
Anti-virals
Remdesivir
Long COVID Symptoms
Lead sponsor: University of Derby
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: University of Plymouth
name: University Hospitals of Derby and Burton NHS Foundation Trust
name: Aston University
name: Royal Devon and Exeter NHS Foundation Trust
First posted: 2023-06-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One study group will receive Remdesivir.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 (\&lt;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 (\&lt;30ml/min) and LFTs ALT\&gt;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.

Primary outcomes:
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 22 days
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
measure: To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
Secondary outcomes:
measure: To identify the most clinically relevant primary outcome for the definitive study
timeFrame: 52 days
measure: To identify the most clinically relevant primary outcome for the definitive study
timeFrame: 52 days
measure: To identify the most clinically relevant primary outcome for the definitive study
timeFrame: 52 days
measure: To identify the most clinically relevant primary outcome for the definitive study
timeFrame: 52 days
measure: To identify the most clinically relevant primary outcome for the definitive study
timeFrame: 55 days
measure: To determine the clinical safety and tolerance parameters of the use of Remdesivir in the treatment of patients with Long COVID.
timeFrame: 55 days
Other outcomes:
Locations:
city: Chesterfield
country: United Kingdom
facility: Derbyshire Community Health Services NHS Foundation Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital (UHDB)
city: Derby
country: United Kingdom
facility: University of Derby
city: Exeter
country: United Kingdom
facility: University of Exeter / Royal Devon University Healthcare NHS FT
Study officials:
affiliation: Pen CTU
name: Victoria Allgar, PhD
role: STUDY_CHAIR
References: