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Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04523181•Golden Biotechnology Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+12 more criteria

Locations (15)

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

Key Dates

Start Date

October 15, 2020

Primary Completion Date

December 23, 2021

Completion Date

December 23, 2021

Last Updated

December 13, 2023

Enrollment

124

ACTUAL participants

Conditions

Covid-19

Interventions

Antroquinonol

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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