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

NCT ID: NCT04523181

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-12-23

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.

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.

Conditions

Covid-19

Keywords

Antroquinonol; COVID 19; pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Antroquinonol with SOC

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

Group Type: ACTIVE_COMPARATOR

Antroquinonol

Intervention Type: DRUG

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

Placebo with SOC

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Capsule without active compound

Interventions

Antroquinonol

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

Intervention Type: DRUG

Placebo

Capsule without active compound

Intervention Type: OTHER

Other Intervention Names

Hocena

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golden Biotechnology Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Franciscan Health Michigan City

Michigan City, Indiana, United States

Ascension.Via Christi Research

Wichita, Kansas, United States

Adventist Healthcare Shady Grove Medical Center

Rockville, Maryland, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Duke University Southeastern Health

Lumberton, North Carolina, United States

Centro Gallego

Buenos Aires, Buenos Aires F.D., Argentina

Clinica de los Virreyes

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Privado Mayo SA

Córdoba, Ciudad de Cordoba, Argentina

Hospital Rawson

Córdoba, Cuidad de Cordoba, Argentina

Clinica Viedma SA

Viedma, Pcia de Rio Negro, Argentina

Clínica Internacional S.A. - Sede Lima

Lima Cercado, Lima region, Peru

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

Callao, , Peru

Hospital de Chancay

Chancay, , Peru

Asociación Civil Selva Amazónica

Iquitos, , Peru

Hospital III Daniel Alcides Carrion - EsSalud

Tacna, , Peru

Countries

United States; Argentina; Peru

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GHCovid-2-001

Identifier Type: -

Identifier Source: org_study_id