Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
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ClinicalTrials.gov Identifier: NCT04523181 |
Recruitment Status :
Recruiting
First Posted : August 21, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid-19 | Drug: Antroquinonol Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 174 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 |
Estimated Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | May 31, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Antroquinonol with SOC
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
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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.
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Drug: Placebo
Capsule without active compound |
- 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
- Time to 2-point improvement [ Time Frame: 28 day ]Clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale
- Duration of hospitalization [ Time Frame: 28 day ]time for patient discharge
- Time to virological clearance [ Time Frame: 28 day ]measured as study days from start of treatment to first negative SARS CoV 2 PCR test

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.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide informed consent.
- Male or female patients between 18 and 80 years of age.
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Hospitalized with 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]).
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 mild to moderate pneumonia.
- Onset of COVID-19 symptoms within 5 days prior to screening.
- SARS CoV 2 infection confirmed by a polymerase chain reaction (PCR) test (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.
- Females 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.
Exclusion Criteria:
- 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 lobar or sublobar consolidation on chest x ray.
- 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 [RRT], ECMO).
- Medical history significant for the following pulmonary diseases: lung cancer, cystic fibrosis, empyema.
- Peripheral capillary oxygen saturation (SpO2) <90% in room air.
- History of buse 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 is allowed if considered SoC, if started prior to randomization.
- 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.
- 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 (e.g., for organ transplantation or autoimmune conditions).
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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.
- Hemoglobin <9 g/dL for females or <11 g/dL for males.
- Absolute neutrophil count <1,500/mm3.
- Thrombocytopenia (platelets count <100 × 109/L).
- Treatment with any antiviral drugs (except remdesivir), 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
- Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease), malabsorption, or diarrhea of any etiology at baseline.
- 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.

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
United States, Indiana | |
Franciscan Health Michigan City | Recruiting |
Michigan City, Indiana, United States, 46360 | |
Contact: Dafer Al-Haddadin, MD 219-879-6531 dafer.al-haddadin@franciscanalliance.org | |
Contact: Kathy Kioussopoulos 317 528 8786 Kathleen.Kioussopoulos@franciscanalliance.org | |
United States, Kansas | |
Ascension.Via Christi Research | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Margaret Hagan, MD 316-291-4774 dr.hagan@viachristi.org | |
Contact: Janie Krull 316-268-8015 janie.krull@ascension.org | |
United States, New Jersey | |
South Jersey Infectious Disease | Recruiting |
Somers Point, New Jersey, United States, 08244 | |
Contact: Christopher Lucasti, DO 609-927-6662 infect123@aol.com | |
Contact: Kelly Freeman 609-927-6662 Kelly.Freeman@sjidtrials.net | |
Argentina | |
Centro Gallego | Recruiting |
Buenos Aires, Capital Federal, Argentina, C1094AAD | |
Contact: Pablo Cruz, MD +54 9 11 3573 6301 imojen@gmail.com | |
Contact: Mariana Calenda (549) 113-1142 ext 920 calendm@hotmail.com | |
Clinica de los Virreyes | Recruiting |
Buenos Aires, Capital Federal, Argentina, C1426AGU | |
Contact: Martin Hojman, MD 54 9 11 555235569 martin_hojman@hotmail.com | |
Contact: Paula Hojman 54 9 11530632999 paulahojman@gmail.com | |
Hospital Rawson | Recruiting |
Cordoba, Cuidad De Cordoba, Argentina, 5000 | |
Contact: Lorena Ravera, MD 54-9- 351-3114358 lorena.ravera@gmail.com | |
Contact: David Viviana 54 9 351 5511771 cic.hospitalrawson@gmail.com | |
Peru | |
Clínica Internacional S.A. - Sede Lima | Recruiting |
Lima Cercado, Lima, Peru, 15001 | |
Contact: Alfredo Guerreros, MD 511-998315497 aguerreros@cinternacional.com.pe | |
Contact: Cinthya Ballona Valdiva +51 995146194 pierina6@hotmail.com | |
Hospital de Chancay | Recruiting |
Chancay, Peru, 15131 | |
Contact: Oscar Carbajal Paulet, MD (+51) 992 772 760 ocarbajalp@gmail.com | |
Contact: Lisbeth Cahuas Villanueva (+51) 964 397 935 lizitavillanueva@hotmail.com |
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 22, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Antroquinonol COVID 19 pneumonia |