A Study of Safety and Efficacy of STIR-101 in Participants Experiencing Symptoms of Long Covid
A Phase 2 Randomized Controlled Trial to Assess Safety and Efficacy of STIR-101 in Individuals with Persistent Post-Viral Symptoms
STIR Pharma Ltd
40 participants
Feb 2, 2026
Interventional
Conditions
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.
Eligibility
Inclusion Criteria14
- Age 18–75 years at Screening
- Documented prior SARS-CoV-2 infection confirmed by PCR, antigen, or serology, OR strong clinical suspicion if prior testing was unavailable.
- Persistent fatigue greater than or equal to 12 weeks after infection and Chalder Fatigue Scale score greater than or equal to 19 at Screening
- Body mass index 18.0–35.0 kg/m²
- 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
- 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
- Capable and willing to comply with all study procedures
- Able to provide written informed consent
Exclusion Criteria13
- Current SARS-CoV-2 infection (positive PCR/antigen within the past 4 weeks)
- Active infection requiring antibiotics or tympanic temperature > 37.5 °C within 72 hours before randomization
- Hospitalization for a non-COVID illness within the previous 30 days
- Pre-existing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia
- Medical conditions that could mimic long-COVID symptoms (e.g., systemic lupus erythematosus, multiple sclerosis, severe anaemia)
- Malignancy within the last 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ)
- Participation in another interventional clinical trial within 30 days before Screening
- Systemic corticosteroid therapy > 10 mg/day prednisone (or equivalent) for > 14 consecutive days in the 30 days before Day 0
- Immunosuppression (e.g., HIV infection, organ or stem-cell transplant, current immunosuppressive therapy, or antiviral/monoclonal antibody treatment for COVID-19 within 60 days)
- Substance abuse (illicit drugs, prescription-drug misuse, or alcohol abuse) within the past 12 months
- Serious psychiatric illness (psychotic disorders, bipolar I/II, major depressive disorder with melancholic features, clinically significant anxiety disorders, dementia, eating disorders, professional burnout)
- 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
- Any condition that, in the Investigator’s judgment, could interfere with trial participation or confound results
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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.
Locations(1)
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ACTRN12625001372471