ISRCTN72940450进行中（未招募）4 期
An open-label, clinical feasibility study of the efficacy of remdesivir for Long-COVID
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
- •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.
研究者
相似试验
已完成
不适用
A clinical study of and Ayurveda Syrup named Amrita Bindu Syrup in treating patients with long term heart burn and sour belchCTRI/2019/01/017357Clinfound Clinical Research Services PvtLtd100
招募中
3 期
Effect of Sauvarchaladi churna in infantile colicCTRI/2018/05/013624KLEU SHRI BMK AYURVEDA MAHAVIDYALAYA AND HOSPITAL SHAHAPUR BELAGAVI KARNATAKA
进行中（未招募）
1 期
An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Aticaprant (JNJ-67953964)CTIS2023-503258-11-00Janssen - Cilag International48
招募中
2 期
Clinical study to evaluate the efficacy of thyroherb tablet in the management of primary hypothyroidismCTRI/2024/03/063679Pankajakasthuri Herbals India Pvt Ltd
已完成
不适用
Prospective evaluation of clinical feasibility of PET-MRCP in diagnosis of biliary strictureJPRN-UMIN000017682Fukushima Medical University30