None listed
Conditions
Brief summary
This purpose of this Phase I study is to evaluate the safety, efficacy and pharmacodynamic effects of two escalating doses of PAX-1 in patients with moderate COVID-19. This study is being performed to address an unmet urgent clinical need for an effective treatment for COVID-19 infection. It is hoped that this treatment is shown to be safe and effective with potential implications for treatment of COVID-19.
Interventions
Phase I, open-label study involving 48 patients
- To evaluate the safety of two escalating doses of PAX-1 in patients with moderate COVID-19.
- To assess the efficacy and pharmacodynamic effects of PAX-1 in patients with moderate COVID-19.
- Investigational Product: PAX-1 (tablet, 2.5mg/tablet)
- Route of administration: Oral
- Frequency of administration: Twice (for 5mg/day dose) or three (for 7.5mg/day dose) times daily for ten days
- Cohorts:
1. 5 mg PAX-1 + Standard of care (SOC)
2. 7.5 mg
Phase I, open-label study involving 48 patients - To evaluate the safety of two escalating doses of PAX-1 in patients with moderate COVID-19. - To assess the efficacy and pharmacodynamic effects of PAX-1 in patients with moderate COVID-19. - Investigational Product: PAX-1 (tablet, 2.5mg/tablet) - Route of administration: Oral - Frequency of administration: Twice (for 5mg/day dose) or three (for 7.5mg/day dose) times daily for ten days - Cohorts: 1. 5 mg PAX-1 + Standard of care (SOC) 2. 7.5 mg PAX-1 + Standard of care (SOC) - The first 20 enrolled patients will be treated with the lowest dose of PAX-1 (5 mg) + SOC. - When all 20 patients have completed treatment, a Data and Safety Monitoring Board (DSMB) will convene to evaluate the safety profile of the dose. - Enrolment of the 20 patients in the 7.5 mg + SOC cohort will begin if and only when the DSMB considers the safety profile of PAX-1 to be appropriate. - Patients in all cohorts will be treated with PAX-1 for 10 days or until complete recovery, whichever occurs first. - Patients in all cohorts will be treated concomitantly with SOC as per local practice and regulatory guidelines. - All patients will ingest medications under clinical monitoring.
Sponsors
Komipharm International Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent by any patient capable of giving consent. 2. Aged between 18 and 60 years. 3. Patient is currently hospitalized. 4. Diagnosis of moderate COVID-19 pneumonia according to WHO criteria (no signs of severe pneumonia [respiratory rate > 30 breaths/min on room air; severe respiratory distress; or SpO2 less than or equal to 93% on room air] and no need for supplemental oxygen) including a positive RT-PCR test for SARS-CoV-2 and lung involvement confirmed with lung imaging technique. 5. Able to take oral medication. 6. Able to comply with the study protocol. 7. Female patients must agree to use a highly effective method of contraception throughout the study and for up to 90 days after stopping treatment. 8. Male subjects should use a condom during treatment and for 90 days following the end of treatment. For a non-pregnant WOCBP partner, contraception recommendations should also be considered as described above.
Exclusion criteria
1. Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for torsade de pointes (TdP) (low left ventricular ejection fraction, left ventricular hypertrophy, ischemia, slow heart rate, and electrolyte abnormalities including hypokalaemia and hypomagnesemia). 2. Patients with uncontrolled cardiac disease. 3. Patients under treatment with drugs having a known risk of prolonging the QT interval and/or inducing TdP.* 4. Patients in treatment with drugs having a known risk of causing neutropenia.* 5. Patients with known or suspected hypersensitivity to sodium metaarsenite, related compounds or any of the excipients of PAX-1. 6. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19) 7. Patients requiring supplemental oxygen at screening. 8. Patient in ICU at screening. 9. Immunosuppressive or immunomodulatory drugs (except for corticosteroids) within the past 3 months. 10. ALT or AST > 5 x ULN at screening. 11. ANC < 1000/µL at screening. 12. Platelet count < 50,000/ µL at screening. 13. Serum creatinine > 2 mg/dL (> 176.8 µmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation. 14. Pregnant or breastfeeding. 15. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of screening. 16. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome, septicaemia). * Concomitant treatments with a known risk of causing neutropenia, and/or of prolonging the QT interval and/or inducing TdP are prohibited during the study.
Outcome results
None listed