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

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ClinicalTrials.gov Identifier: NCT04523181
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Antroquinonol Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
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
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
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Antroquinonol with SOC
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
 Drug: Antroquinonol
double-blind for antroquinonol and Placebo with same out-look and same frequency.
Other Name: Hocena
Placebo Comparator: Placebo with SOC
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
 Drug: Placebo
Capsule without active compound


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to 2-point improvement [ Time Frame: 28 day ]
    Clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale

  2. Duration of hospitalization [ Time Frame: 28 day ]
    time for patient discharge

  3. Time to virological clearance [ Time Frame: 28 day ]
    measured as study days from start of treatment to first negative SARS CoV 2 PCR test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide informed consent.
  2. Male or female patients between 18 and 80 years of age.

  3. Hospitalized with 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]).

    Note: Hospitalized patients can also include patients admitted to centers conditioned as hospitals to treat COVID-19 patients.

  4. Chest x ray or computerized tomography (CT) scan consistent with mild to moderate pneumonia.
  5. Onset of COVID-19 symptoms within 5 days prior to screening.
  6. SARS CoV 2 infection confirmed by a polymerase chain reaction (PCR) test (nasopharyngeal, oropharyngeal, or respiratory samples, not serology testing).
  7. Male patients and female patients of childbearing potential must agree to use protocol-specified methods of contraception.
  8. Females patients of childbearing potential must have a negative pregnancy test at Screening or pretreatment on Day 1.
  9. 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.
  10. 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 lobar or sublobar consolidation on chest x ray.
  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 [RRT], ECMO).
  5. Medical history significant for the following pulmonary diseases: lung cancer, cystic fibrosis, empyema.
  6. Peripheral capillary oxygen saturation (SpO2) <90% in room air.
  7. History of buse 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 is allowed if considered SoC, if started prior to randomization.
  9. 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.
  10. Use of Antrodia camphorata -containing products within 2 weeks prior to the first administration of study drug.
  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 (e.g., 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 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 (e.g., 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523181


Locations
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United States, Indiana
Franciscan Health Michigan City Recruiting
Michigan City, Indiana, United States, 46360
Contact: Dafer Al-Haddadin, MD    219-879-6531    dafer.al-haddadin@franciscanalliance.org   
Contact: Kathy Kioussopoulos    317 528 8786    Kathleen.Kioussopoulos@franciscanalliance.org   
United States, Kansas
Ascension.Via Christi Research Recruiting
Wichita, Kansas, United States, 67214
Contact: Margaret Hagan, MD    316-291-4774    dr.hagan@viachristi.org   
Contact: Janie Krull    316-268-8015    janie.krull@ascension.org   
United States, New Jersey
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
Contact: Christopher Lucasti, DO    609-927-6662    infect123@aol.com   
Contact: Kelly Freeman    609-927-6662    Kelly.Freeman@sjidtrials.net   
Argentina
Centro Gallego Recruiting
Buenos Aires, Capital Federal, Argentina, C1094AAD
Contact: Pablo Cruz, MD    +54 9 11 3573 6301    imojen@gmail.com   
Contact: Mariana Calenda    (549) 113-1142 ext 920    calendm@hotmail.com   
Clinica de los Virreyes Recruiting
Buenos Aires, Capital Federal, Argentina, C1426AGU
Contact: Martin Hojman, MD    54 9 11 555235569    martin_hojman@hotmail.com   
Contact: Paula Hojman    54 9 11530632999    paulahojman@gmail.com   
Hospital Rawson Recruiting
Cordoba, Cuidad De Cordoba, Argentina, 5000
Contact: Lorena Ravera, MD    54-9- 351-3114358    lorena.ravera@gmail.com   
Contact: David Viviana    54 9 351 5511771    cic.hospitalrawson@gmail.com   
Peru
Clínica Internacional S.A. - Sede Lima Recruiting
Lima Cercado, Lima, Peru, 15001
Contact: Alfredo Guerreros, MD    511-998315497    aguerreros@cinternacional.com.pe   
Contact: Cinthya Ballona Valdiva    +51 995146194    pierina6@hotmail.com   
Hospital de Chancay Recruiting
Chancay, Peru, 15131
Contact: Oscar Carbajal Paulet, MD    (+51) 992 772 760    ocarbajalp@gmail.com   
Contact: Lisbeth Cahuas Villanueva    (+51) 964 397 935    lizitavillanueva@hotmail.com   
Sponsors and Collaborators
Golden Biotechnology Corporation
More Information
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Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT04523181    
Other Study ID Numbers: GHCovid-2-001
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Golden Biotechnology Corporation:
Antroquinonol
COVID 19
pneumonia