Phase 1, Open-label, Two-Cohort Study of Orally Administered PAX-1 in Patients with Moderate COVID-19

Phase 1

• Conditions: COVID-19; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12622000958785
• Lead Sponsor: Komipharm International Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-06
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified