Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT05911906
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 (\<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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05911906
Study Brief:
Protocol Section:
NCT05911906