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

Sponsor
Golden Biotechnology Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04523181
Collaborator
(none)
124
Enrollment
15
Locations
2
Arms
14.5
Actual Duration (Months)
8.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 19A 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 :
Oct 8, 2020
Actual Primary Completion Date :
Dec 23, 2021
Actual Study Completion Date :
Dec 23, 2021

Arms and Interventions

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 Names:
  • Hocena

    		•
    Placebo Comparator: Placebo with SOC

    placebo (1 capsule) administered twice daily (BID) orally, for 14 days.

    Other: Placebo
    Capsule without active compound

    Outcome Measures

    Primary Outcome Measures

    1. recover ratio [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 [28 day]

      Clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale

    2. Duration of hospitalization [28 day]

      time for patient discharge

    3. Time to virological clearance [28 day]

      measured as study days from start of treatment to first negative SARS CoV 2 PCR test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. Chest x ray or computerized tomography (CT) scan consistent with pneumonia.

    2. Onset of COVID-19 symptoms within 2 weeks prior to randomization.

    3. 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).

    4. Male patients and female patients of childbearing potential must agree to use protocol-specified methods of contraception.

    5. Female patients of childbearing potential must have a negative pregnancy test at Screening or pretreatment on Day 1.

    6. 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.

    7. 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:

    14. Estimated glomerular filtration rate <50 mL/min.

    15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN.

    16. Total bilirubin >1.5 × ULN, unless the patient has known Gilbert's syndrome.

    17. Hemoglobin <9 g/dL for females or <11 g/dL for males.

    18. Absolute neutrophil count <1,500/mm3.

    19. Thrombocytopenia (platelets count <100 × 109/L).

    20. 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.

    21. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, Crohn's disease), malabsorption, or diarrhea of any etiology at baseline.

    22. 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

    Locations

    Site City State Country Postal Code
    1 Franciscan Health Michigan City Michigan City Indiana United States 46360
    2 Ascension.Via Christi Research Wichita Kansas United States 67214
    3 Adventist Healthcare Shady Grove Medical Center Rockville Maryland United States 20850-3357
    4 South Jersey Infectious Disease Somers Point New Jersey United States 08244
    5 Duke University Southeastern Health Lumberton North Carolina United States 28358
    6 Centro Gallego Buenos Aires Capital Federal Argentina C1094AAD
    7 Clinica de los Virreyes Buenos Aires Capital Federal Argentina C1426AGU
    8 Sanatorio Privado Mayo SA Cordoba Ciudad De Cordoba Argentina 5000
    9 Hospital Rawson Cordoba Cuidad De Cordoba Argentina 5000
    10 Clinica Viedma SA Viedma Pcia De Rio Negro Argentina R8500
    11 Clínica Internacional S.A. - Sede Lima Lima Cercado Lima Peru 15001
    12 Unidad de Investigacion, Hospital Nacional IV Alberto Sabogal Sologuren-Essalud, Red Assitencial Sabogal Callao Peru 07011
    13 Hospital de Chancay Chancay Peru 15131
    14 Asociación Civil Selva Amazónica Iquitos Peru 16001
    15 Hospital III Daniel Alcides Carrion - EsSalud Tacna Peru 23000

    Sponsors and Collaborators

    • Golden Biotechnology Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Golden Biotechnology Corporation
    ClinicalTrials.gov Identifier:
    NCT04523181
    Other Study ID Numbers:
    • GHCovid-2-001
    First Posted:
    Aug 21, 2020
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    COVID-19

    Study Results

    No Results Posted as of Jan 6, 2022