None listed
Conditions
Brief summary
The purpose of this research is to see if the investigational drug STIR-101 is safe and effective in improving fatigue caused by Long COVID. The study will look at Fatigue measured by a patient questionnaire and aims to show that treatment with STIR-101 will provide a greater improvement in fatigue after 56 days of treatment than placebo would.
Interventions
A comparison of STIR-101 vs Placebo in the treatment of fatigue in patients with Long Covid. Study participants will be randomised 1:1 to receive either;
STIR-101 350mg capsules will be taken orally 2 capsules twice daily for 56 days.
Compliance will be assessed by site review (at Day 14, Day 28, Day 56) of a daily dosing diary completed by the participant and cross checked against returned study drug count at Day 28 and Day 56.
Sponsors
STIR Pharma Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18–75 years at Screening 2. Documented prior SARS-CoV-2 infection confirmed by PCR, antigen, or serology, OR strong clinical suspicion if prior testing was unavailable. 3. Persistent fatigue greater than or equal to 12 weeks after infection and Chalder Fatigue Scale score greater than or equal to 19 at Screening 4. Body mass index 18.0–35.0 kg/m² 5. Female participants of childbearing potential must; a. Not be pregnant, breastfeeding, or planning pregnancy during the trial period b. Have a negative pregnancy test at Screening and on Day 0 prior to first dose c. Agree to remain abstinent or use medically effective contraception, or have a sterile or same-sex partner, from Screening through 30 days after the last dose d. Refrain from egg donation during the study and for 30 days after the last dose 6. Male participants who are not surgically sterile must: e. Not donate sperm from the date of ICF signing through 30 days post last dose. f. If sexually active with a female partner of childbearing potential, use a highly effective method of contraception during this same period 7. Capable and willing to comply with all study procedures 8. Able to provide written informed consent
Exclusion criteria
1. Current SARS-CoV-2 infection (positive PCR/antigen within the past 4 weeks) 2. Active infection requiring antibiotics or tympanic temperature > 37.5 °C within 72 hours before randomization 3. Hospitalization for a non-COVID illness within the previous 30 days 4. Pre-existing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia 5. Medical conditions that could mimic long-COVID symptoms (e.g., systemic lupus erythematosus, multiple sclerosis, severe anaemia) 6. Malignancy within the last 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ) 7. Participation in another interventional clinical trial within 30 days before Screening 8. Systemic corticosteroid therapy > 10 mg/day prednisone (or equivalent) for > 14 consecutive days in the 30 days before Day 0 9. Immunosuppression (e.g., HIV infection, organ or stem-cell transplant, current immunosuppressive therapy, or antiviral/monoclonal antibody treatment for COVID-19 within 60 days) 10. Substance abuse (illicit drugs, prescription-drug misuse, or alcohol abuse) within the past 12 months 11. Serious psychiatric illness (psychotic disorders, bipolar I/II, major depressive disorder with melancholic features, clinically significant anxiety disorders, dementia, eating disorders, professional burnout) 12. Clinically significant laboratory abnormalities at Screening or pre-Baseline: • Neutrophils < 1.5 × 1000/uL, platelets < 100 × 1000/uL, hemoglobin < 90 g/L • Serum creatinine > 1.5 × ULN or estimated GFR < 60 mL/min • AST or ALT > 3 × ULN; total bilirubin > 1.5 × ULN • TSH > 6.0 mIU/L or < 0.4 mIU/L 13. Any condition that, in the Investigator’s judgment, could interfere with trial participation or confound results
Outcome results
None listed