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

NCT04523181 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GHCovid-2-001
• Study Type: interventional
• Target: 124
• Locations: 3 countries
• Sites: 15

Brief Summary

To evaluate the safety and efficacy 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.

Conditions

Covid-19

Keywords

Antroquinonol; COVID 19; pneumonia

Outcome Measures

Primary Outcomes (1)

• Recover Ratio

  Number 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.

  14 day

Secondary Outcomes (4)

• Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale

  28-day

• Duration of Hospitalization

  28 day

• Time to Virological Clearance

  28 day

• Number of Patients Who Recovered From Loss of Taste or Smell

  28 days

Study Arms (2)

Antroquinonol with SOC

ACTIVE COMPARATOR

Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.

Drug: Antroquinonol

Placebo with SOC

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Antroquinonol DRUG

double-blind for antroquinonol and Placebo with same out-look and same frequency.

Also known as: Hocena

Antroquinonol with SOC

Placebo OTHER

Capsule without active compound

Placebo with SOC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent.
• Male or female patients between 18 and 80 years of age.
• Oxygen Saturation \<94% in room air at screening.
• 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.
• Chest x ray or computerized tomography (CT) scan consistent with pneumonia.
• Onset of COVID-19 symptoms within 2 weeks prior to randomization.
• 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).
• Male patients and female patients of childbearing potential must agree to use protocol-specified methods of contraception.
• Female patients of childbearing potential must have a negative pregnancy test at Screening or pretreatment on Day 1.
• 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.
• Patient is, in the opinion of the investigator, willing and able to comply with the study treatment regimen and all other study requirements.

You may not qualify if:

• Female patient is pregnant or breastfeeding.
• Any patient's concomitant life threatening condition, including but not limited to: requiring mechanical ventilation, acute respiratory distress syndrome, shock, or cardiac failure.
• Evidence of multi lobar consolidation pneumonia or cavities on chest x ray or CT scan.
• 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).
• Medical history significant for the following pulmonary diseases: lung cancer, cystic fibrosis, empyema.
• Respiratory rate \>30 respirations per minute.
• History of abuse of drugs or alcohol that could interfere with adherence to study requirements, as judged by the investigator.
• 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.
• Use of Antrodia camphorata -containing products within 2 weeks prior to the first administration of study drug.
• Clinically significant abnormal electrocardiogram (ECG) at Screening, as determined by the investigator.
• 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).
• Abnormal laboratory values at Screening:
• Estimated glomerular filtration rate \<50 mL/min.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN), or ALT/AST \>3 × ULN plus total bilirubin \>2 × ULN.
• Total bilirubin \>1.5 × ULN, unless the patient has known Gilbert's syndrome.

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead

Study Sites (15)

Franciscan Health Michigan City

Michigan City, Indiana, 46360, United States

Location

Ascension.Via Christi Research

Wichita, Kansas, 67214, United States

Location

Adventist Healthcare Shady Grove Medical Center

Rockville, Maryland, 20850-3357, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

Duke University Southeastern Health

Lumberton, North Carolina, 28358, United States

Location

Centro Gallego

Buenos Aires, Buenos Aires F.D., C1094AAD, Argentina

Location

Clinica de los Virreyes

Buenos Aires, Buenos Aires F.D., C1426AGU, Argentina

Location

Sanatorio Privado Mayo SA

Córdoba, Ciudad de Cordoba, 5000, Argentina

Location

Hospital Rawson

Córdoba, Cuidad de Cordoba, 5000, Argentina

Location

Clinica Viedma SA

Viedma, Pcia de Rio Negro, R8500, Argentina

Location

Clínica Internacional S.A. - Sede Lima

Lima Cercado, Lima region, 15001, Peru

Location

Unidad de Investigacion, Hospital Nacional IV Alberto Sabogal Sologuren-Essalud, Red Assitencial Sabogal

Callao, 07011, Peru

Location

Hospital de Chancay

Chancay, 15131, Peru

Location

Asociación Civil Selva Amazónica

Iquitos, 16001, Peru

Location

Hospital III Daniel Alcides Carrion - EsSalud

Tacna, 23000, Peru

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Howard Cheng
• Organization: Golden Biotechnology Corporation

howard@goldenbiotech.com

+886228086006

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, Placebo Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: October 15, 2020
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PE (5); AR (5); US (5)