Long COVID Infections and Infestations
Conditions
Interventions
Trial design: Randomised double-blind placebo-controlled trial. Interested adults who are diagnosed with long COVID (defined as per NICE guidelines - NG188) that affect and limit their everyday activi
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adults (18 years or older) with the capacity to provide informed consent, and 2. Have been diagnosed with Long COVID as per the NICE Guidelines (NG188) – that is, either one of “Ongoing symptomatic COVID-19; signs and symptoms of COVID-19 from 4 weeks up to 12 weeks”, or “Post-COVID-19 syndrome; Signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis. It usually presents with clusters of symptoms, often overlapping, which can fluctuate and change over time and can affect any system in the body. Post-COVID-19 syndrome may be considered before 12 weeks while the possibility of an alternative underlying disease is also being assessed”. The diagnosis will be confirmed by the participant’s GP and/or 3. medical records. 4. Report that their Long COVID has reduced their ability to carry out day-to-day activities compared with the time before they had COVID-19. 5. Willing and able to complete the study protocols (take trial medication regularly for 3 months, complete online telephone or postal surveys monthly, and participate in clinical monitoring assessment monthly) 6. Not taking any other herbal medicines, or willing to stop taking any such medicines for the duration of the trial. Herbal medicine is defined as a plant or plant part, or mixture or extract of these, which is taken in medicinal form to improve health, prevent disease, or treat illness
Exclusion criteria
Exclusion criteria: 1. Self-diagnosed Long COVID in the absence of a clinical diagnosis as per the NICE Guidelines 2. Any medical condition or suspected medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study (this may involve conduct of any clinical assessment deemed necessary by the study investigator to confirm that this criterion is met, such as (but not limited to) validated psychiatric scales, ECGs, and laboratory tests for clinical chemistry, haematology, urinalysis, kidney function, etc). 3. Previous clinical diagnosis of severe psychiatric disorders 4. Abnormal liver function test results, as indicated by alanine aminotransferase or aspartate aminotransferase or total bilirubin >2 x ULN, either measured as part of routine care within past 3 months or conducted for the purposes of the clinical trial (if a recent test result is not available). 5. Previous clinical diagnosis of chronic kidney disease or other medical condition associated with impaired kidney function 6. Previous clinical diagnosis of heart disease or other cardiac problems 7. Use of any investigational products within 5 elimination half-lives after the last dose or at screening 8. History of malignancy unless resolved by adequate treatment with no evidence of recurrence 9. Hypersensitivity to the active substance or to any of the excipients 10. Women breastfeeding or with a positive urine pregnancy test at screening 11. Women planning to become pregnant for the duration of the participation in the study 12. Men and women of childbearing potential unwilling to adhere to the relevant contraception requirements for the duration of the study (until at least 24 hours after the final dose of trial medication is taken). Women of childbearing potential (WOCBP) are defined as all women who are: “fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.” Acceptable contraception methods for WOCBP in this trial include: combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence, or condom use. Sexual abstinence is defined as: “refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject”. Male participants are required to use condoms. All participants are required to inform investigator immediately if these contraception requirements are not met or if pregnancy is suspected. 13. Participants taking benzodiazepines, anticonvulsants, barbiturates or any other CNS depressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported functional status measured using the Post-COVID-19 Functional Status Scale (PCFS), at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 1 month, 2 months and 3 months 1. Quality of life by PROMIS 29+2 summary score 2. Self-reported fatigue, pain, sleep, anxiety, depression and social, physical and cognitive function by PROMIS 29+2 individual dimensions 3. Self-reported breathlessness by modified MRC Dyspnoea Scale 4. Health utility by EQ 5D-5L utility score 5. Self-reported work status and productivity 6. Other self-reported symptoms 7. Number of adverse events (3 months) | — |
Countries
England, United Kingdom
Contacts
Public ContactPoppy Mallinson
Outcome results
None listed