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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

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 Other: 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 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
Actual Primary Completion Date : December 23, 2021
Actual Study Completion Date : December 23, 2021

Resource links provided by the National Library of Medicine


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.
Other: Placebo
Capsule without active compound




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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.

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
Michigan City, Indiana, United States, 46360
United States, Kansas
Ascension.Via Christi Research
Wichita, Kansas, United States, 67214
United States, Maryland
Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, United States, 20850-3357
United States, New Jersey
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, North Carolina
Duke University Southeastern Health
Lumberton, North Carolina, United States, 28358
Argentina
Centro Gallego
Buenos Aires, Capital Federal, Argentina, C1094AAD
Clinica de los Virreyes
Buenos Aires, Capital Federal, Argentina, C1426AGU
Sanatorio Privado Mayo SA
Cordoba, Ciudad De Cordoba, Argentina, 5000
Hospital Rawson
Cordoba, Cuidad De Cordoba, Argentina, 5000
Clinica Viedma SA
Viedma, Pcia De Rio Negro, Argentina, R8500
Peru
Clínica Internacional S.A. - Sede Lima
Lima Cercado, Lima, Peru, 15001
Unidad de Investigacion, Hospital Nacional IV Alberto Sabogal Sologuren-Essalud, Red Assitencial Sabogal
Callao, Peru, 07011
Hospital de Chancay
Chancay, Peru, 15131
Asociación Civil Selva Amazónica
Iquitos, Peru, 16001
Hospital III Daniel Alcides Carrion - EsSalud
Tacna, Peru, 23000
Sponsors and Collaborators
Golden Biotechnology Corporation
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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 6, 2022
Last Verified: August 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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases