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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523181
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 21, 2020
Last Update Posted Date January 6, 2022
Actual Study Start Date  ICMJE October 8, 2020
Actual Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Covid-19
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2022)
124
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
174
Actual Study Completion Date  ICMJE December 23, 2021
Actual Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Peru,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04523181
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Golden Biotechnology Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Golden Biotechnology Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Golden Biotechnology Corporation
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP