Are anti-viral medications (remdesivir) a safe and feasible drug to improve outcomes for those living with Long COVID?
- Conditions
- Post COVID-19 condition, post COVID syndrome and/or Long COVIDInfections and Infestations
- Registration Number
- ISRCTN72940450
- Lead Sponsor
- niversity of Derby
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 72
1. =18 years of age at the time of enrolment
2. Previously confirmed or suspected SARS-CoV-2 infection
3. Confirmed or suspected 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
4. Willing and able to provide informed consent, complete the surveys, and complete all planned clinical assessments, and return for scheduled study visits
5. Has the use of a smartphone
6. Evidence of persistent symptom profile relative to pre-COVID-19 status as derived from patient reported outcome measures
*The WHO defines 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
1. Treatment history of remdesivir, molnupiravir, paxlovid and/or any other COVID-19 antiviral medication (<6 months)
2. A diagnosis of a compromised immune system or function from a healthcare professional
3. Currently engaged in a physical rehabilitation programme or intervention aimed to improve Long COVID symptom profile and/or functional status
4. Recognised as a ‘severe risk’ of experiencing post-exertional malaise following engagement in physical tasks. Determined using the De Paul symptom questionnaire
5. Lack of mental capacity to provide informed consent
6. Unable to understand verbal English/have a hearing impairment that prevents adequate communication*
7. Participation in another clinical drug trial within the last 6 months
8. Currently pregnant, breastfeeding or attempting to get pregnant (i.e., not using effective methods of contraception)
9. 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/
10. History of adverse reactions to anti-viral medication and intravenous/infusions
11. History of hepatic or renal impairment (eGFR <30 ml/min and LFTs ALT > x5 ULN)
12. 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:
1. 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 other than English.
2. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients: 1. Rates of screening (overall and by centre) measured at the end of recruitment2. Recruitment rate (number of patients consented as a proportion of those screened by the different recruitment pathways) measured at the end of recruitment3. Retention and dropout rate (due to the treatment and/or trial demands, overall and by centre) measured at last patient last visit4. Adherence to treatment regime (number of participants attending clinic appointments and completing each treatment session [Days 14-22])5. Attendance and completeness of study assessments (CPET, bloods, PET/CT if in Exeter) on Days 7, 8, 44, 51, 52 (52 in Exeter)6. Completeness of all data collection activities including baseline and +28 days after IMP 7. Completion of patient-reported outcome measurements (>60% completion) on Days 0, 7, 8, 44, 51, 52
- Secondary Outcome Measures
Name Time Method