None listed
Conditions
Brief summary
The proposed study will allow for an initial assessment of the safety, tolerability, and antiviral activity of multiple doses of BIT225 in SARS-CoV-2 infected patients. The proposed study in SARS-CoV-2 will expand the knowledge of the antiviral and immune-modulatory capabilities of BIT225, and determine potential benefits to SARS-CoV-2 infected individuals. The role of BIT225 will be investigated in this proposed study of SARS-CoV-2 infected individuals, with special attention on immune and inflammatory activation markers, viral decay kinetics and time to resolution of symptoms. This study aims to demonstrate if treatment with BIT225 within 3 days of onset of COVID-19 symptoms will result in reduction in SARS-CoV-2 plasma viral load, clinically favourable changes in viral, inflammatory and immune activation markers, as well as improvement in clinical symptoms of COVID-19 infection.
Interventions
Screening, enrolment, treatment randomisation and first dosing will occur on Screening / Day 1
Arm 1-BIT225 200mg (1 x 100mg capsule) twice daily (BID), oral, from Day 1 to Day 7
Arm 2-BIT225 400mg (2 x 100mg capsule) twice daily (BID), oral, from Day 1 to Day 7
Capsule counts on return will be used to monitor adherence.
Sponsors
Biotron Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. Non-hospitalised, males or females aged 18-59 years with symptoms of mild to moderate SARS-CoV-2, including any cough, sore throat, fever, chills, nasal discharge, shortness of breath, fatigue, myalgias, malaise, headache, nausea, vomiting, diarrhea, alteration of taste or smell, that in the opinion of the Investigator are consistent with a presumptive diagnosis of SARS-CoV-2. 2. Rapid Antigen Test or PCR evidence confirming infection with SARS-CoV-2; documentation of a positive test within the past 24 hours. 3. Symptoms of =/< 3 days consistent with acute SARS-CoV-2 infection. 4. Room air oxygen saturation >/= 93% 5. Participants may have mild or well controlled comorbid conditions. 6. SARS-CoV-2 vaccinated, or unvaccinated individuals will be eligible for screening and enrolment. 7. Females of reproductive potential (defined as women who have not been post-menopausal for at least 12 consecutive months, i.e., who have had menses within the preceding 12 months, or women who have not undergone surgical sterilisation via hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy and/or tubal ligation), must: Have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL at Screening 8. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant, or to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the participant and partner must agree to use reliable methods of contraception while receiving study treatment. 9. Participants who are not of reproductive potential (women who have been post-menopausal for at least 12 consecutive months or have undergone hysterectomy, bilateral salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives. 10. Provide written informed consent to participate in the study and be willing to comply with the study procedures
Exclusion criteria
1. Individuals who would be excluded following the current Thai Ministry of Public Health (MOPH) COVID-19 National Guidelines. 2. In the opinion of the investigator, any participant who is likely to require hospitalisation, for any reason, within the next 48 hours. 3. Participants who have received non-vaccination treatment for SARS-CoV-2 within 30 days prior to study entry, e.g., remdesivir, Paxlovid, molnuparivir, SARS-CoV-2 monoclonal Abs, convalescent serum, or other anti- SARS-CoV-2 agents with national regulatory approval, zinc, or Andrographis paniculata. 4. Known current, or past, history of clinically significant arrhythmia. 5. Screening ECG QTcF value >/= 450 ms. 6. Pregnancy or breastfeeding. 7. Serious illness, that in the opinion of the site Investigator, is not considered medically stable. 8. Hospitalisation, for any reason, within the past 7 days. 9. The consumption / administration of excluded concomitant medication at the time of the Screening visit or during the treatment course of the study. 10. Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements or compromise participant safety. 11. Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation 12. Presence of a condition, that in the opinion of the Investigator, would place the participant at increased risk from study participation, or compromise data integrity.
Outcome results
None listed