Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients

• ClinicalTrials.gov Identifier: NCT04523181
• Recruitment Status: Completed
• First Posted: August 21, 2020
• Last Update Posted: January 6, 2022
• Sponsor: Golden Biotechnology Corporation
• Information provided by (Responsible Party): Golden Biotechnology Corporation

Tracking Information

• First Submitted Date: August 19, 2020
• First Posted Date: August 21, 2020
• Last Update Posted Date: January 6, 2022
• Actual Study Start Date: October 8, 2020
• Actual Primary Completion Date: December 23, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2020)

recover ratio [ Time Frame: 14 day ]

The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 7, 2020)

• Time to 2-point improvement [ Time Frame: 28 day ]
  Clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale
• Duration of hospitalization [ Time Frame: 28 day ]
  time for patient discharge
• Time to virological clearance [ Time Frame: 28 day ]
  measured as study days from start of treatment to first negative SARS CoV 2 PCR test

Original Secondary Outcome Measures (submitted: August 20, 2020)

• Time to 2-point improvement [ Time Frame: 28 day ]
  Clinical improvement score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale
• Duration of hospitalization [ Time Frame: 28 day ]
  time for patient discharge
• Time to virological clearance [ Time Frame: 28 day ]
  measured as study days from start of treatment to first negative SARS CoV 2 PCR test

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
• Official Title: 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
• Brief Summary: To evaluate the safety andefficacy 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.
• Detailed Description: This is a randomized, double blind, placebo controlled, Phase 2, proof of concept study in hospitalized patients with mild to moderate pneumonia due to COVID 19. Written informed consent must be obtained from all patients during screening. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive antroquinonol or placebo for 14 days in combination with SoC therapy per local SoC policies.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

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

Primary Purpose: Treatment

• Condition: Covid-19

Intervention

• Drug: Antroquinonol
  double-blind for antroquinonol and Placebo with same out-look and same frequency.
  Other Name: Hocena
• Other: Placebo
  Capsule without active compound

Study Arms

• Active Comparator: Antroquinonol with SOC
  Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
  Intervention: Drug: Antroquinonol
• Placebo Comparator: Placebo with SOC
  placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2022): 124
• Original Estimated Enrollment (submitted: August 20, 2020): 174
• Actual Study Completion Date: December 23, 2021
• Actual Primary Completion Date: December 23, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Peru, United States

Administrative Information

• NCT Number: NCT04523181
• Other Study ID Numbers: GHCovid-2-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Golden Biotechnology Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Golden Biotechnology Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Golden Biotechnology Corporation
• Verification Date: August 2021