Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
Condition: Covid-19
MeSH terms: COVID-19
Intervention: Antroquinonol; Placebo
Intervention description: double-blind for antroquinonol and Placebo with same out-look and same frequency.; Capsule without active compound
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 2 Randomized, Double blind, Placebo Controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients with Mild to Moderate Pneumonia due to COVID 19
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind, Placebo Controlled
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Antroquinonol; COVID 19; pneumonia

Summary:

      To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia
      due to COVID-19, as measured by the proportion of patients alive and free of respiratory
      failure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide informed consent.

          2. Male or female patients between 18 and 80 years of age.

          3. Oxygen Saturation <94% in room air at screening.

          4. Hospitalized with mild COVID 19 disease (not requiring oxygen therapy [WHO COVID-19
             Clinical Improvement Ordinal Scale, score of 3] or requiring oxygen therapy by mask or
             nasal prong [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 4]).
             Requirement of oxygen therapy by mask with reservoir to treat severe COVID 19
             pneumonia is not allowed for enrollment.

             Note: Hospitalized patients can also include patients admitted to centers conditioned
             as hospitals to treat COVID-19 patients.

          5. Chest x ray or computerized tomography (CT) scan consistent with pneumonia.

          6. Onset of COVID-19 symptoms within 2 weeks prior to randomization.

          7. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) infection confirmed by a
             polymerase chain reaction (PCR) test, antigen, or any authorized commercial or public
             health assay (nasopharyngeal, oropharyngeal, or respiratory samples, not serology
             testing).

          8. Male patients and female patients of childbearing potential must agree to use
             protocol-specified methods of contraception.

          9. Female patients of childbearing potential must have a negative pregnancy test at
             Screening or pretreatment on Day 1.

         10. Male patients must agree not to donate sperm from the first dose through 90 days after
             the last dose of study treatment; female patients of childbearing potential should
             refrain from donation of ova from Day 1 until 90 days after the last dose of study
             treatment.

         11. Patient is, in the opinion of the investigator, willing and able to comply with the
             study treatment regimen and all other study requirements.

        Exclusion Criteria:

          1. Female patient is pregnant or breastfeeding.

          2. Any patient's concomitant life threatening condition, including but not limited to:
             requiring mechanical ventilation, acute respiratory distress syndrome, shock, or
             cardiac failure.

          3. Evidence of multi lobar consolidation pneumonia or cavities on chest x ray or CT scan.

          4. Severe COVID 19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal
             Scale, scores of 5 (non invasive ventilation or high flow oxygen), 6 (intubation and
             mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal
             replacement therapy, ECMO).

          5. Medical history significant for the following pulmonary diseases: lung cancer, cystic
             fibrosis, empyema.

          6. Respiratory rate >30 respirations per minute.

          7. History of abuse of drugs or alcohol that could interfere with adherence to study
             requirements, as judged by the investigator.

          8. Treatment with other drugs thought to possibly have activity against COVID 19 within 7
             days prior to enrollment or concurrently. Note: remdesivir or other authorized
             treatments for COVID 19 is allowed if considered SoC, if started prior to
             randomization or during the study.

          9. Use of Antrodia camphorata -containing products within 2 weeks prior to the first
             administration of study drug.

         10. Use of other investigational drugs within 30 days of dosing, or plans to enroll in
             another clinical trial of an investigational agent while participating in the present
             study. Note: authorized COVID 19 vaccines are not considered investigational and are
             not exclusionary.

         11. Clinically significant abnormal electrocardiogram (ECG) at Screening, as determined by
             the investigator.

         12. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of
             prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (eg, for
             organ transplantation or autoimmune conditions).

         13. Abnormal laboratory values at Screening:

               1. Estimated glomerular filtration rate <50 mL/min.

               2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper
                  limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN.

               3. Total bilirubin >1.5 × ULN, unless the patient has known Gilbert's syndrome.

               4. Hemoglobin <9 g/dL for females or <11 g/dL for males.

               5. Absolute neutrophil count <1,500/mm3.

               6. Thrombocytopenia (platelets count <100 × 109/L).

         14. Treatment with any antiviral drugs (except remdesivir or other authorized treatments
             for COVID 19), or with any drugs known to be strong inducers or inhibitors of
             cytochrome P450 isoform (CYP) 2C19, CYP3A4, CYP2C8, and CYP2E1 within 14 days or 5
             half lives prior to the start of study treatment. Drugs with a narrow therapeutic
             index that are substrates of 1A2, 2B6, 2C8, 2C9, 2C19, 3A, and 2D6 are also
             prohibited.

         15. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea
             (eg, Crohn's disease), malabsorption, or diarrhea of any etiology at baseline.

         16. Any other clinically significant medical condition or laboratory abnormality that, in
             the opinion of the investigator, would jeopardize the safety of the patient or
             potentially impact patient compliance or the safety/efficacy observations in the
             study.