Covid-19Phase 2NCT04523181
Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
A Phase 2 study testing Antroquinonol in people with Covid-19, run by Golden Biotechnology Corporation at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid-19
- What is being tested?
- Antroquinonol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 15 Oct 2020to 23 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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 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.
- Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, 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.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States5 sites
Duke University Southeastern Health
Lumberton, North Carolina, 28358
Franciscan Health Michigan City
Michigan City, Indiana, 46360
Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, 20850-3357
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Ascension.Via Christi Research
Wichita, Kansas, 67214
Argentina5 sites
Centro Gallego
Buenos Aires, Buenos Aires F.D., C1094AAD
Clinica de los Virreyes
Buenos Aires, Buenos Aires F.D., C1426AGU
Sanatorio Privado Mayo SA
Córdoba, Ciudad de Cordoba, 5000
Hospital Rawson
Córdoba, Cuidad de Cordoba, 5000
Clinica Viedma SA
Viedma, Pcia de Rio Negro, R8500
Peru5 sites
Unidad de Investigacion, Hospital Nacional IV Alberto Sabogal Sologuren-Essalud, Red Assitencial Sabogal
Callao, 07011
Hospital de Chancay
Chancay, 15131
Asociación Civil Selva Amazónica
Iquitos, 16001
Clínica Internacional S.A. - Sede Lima
Lima Cercado, Lima region, 15001
Hospital III Daniel Alcides Carrion - EsSalud
Tacna, 23000
About this study
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
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.
Read the 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
- Being tested
- Antroquinonol, Placebo
- Keywords
- Antroquinonol, COVID 19, pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntroquinonolDrug
Also called Hocena
double-blind for antroquinonol and Placebo with same out-look and same frequency.
PlaceboOther
Capsule without active compound
| Study group | Role | What they receive |
|---|---|---|
| Antroquinonol with SOC | Active comparator | Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days. Receives: Drug: Antroquinonol |
| Placebo with SOC | Placebo comparator | Placebo (1 capsule) administered twice daily (BID) orally, for 14 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time to 2-point improvement from baseline, time to score 2 and lower from baseline and time to score 0 from baseline are measured by WHO COVID-19 Clinical Improvement Ordinal Scale
Measured: 28-day
Duration of Hospitalization
Duration of hospitalization is the total number of days the patient is hospitalized during their participation in the study, up to Day 28.
Measured: 28 day
Time to Virological Clearance
measured as study days from start of treatment to first negative SARS CoV 2 PCR test
Measured: 28 day
Number of Patients Who Recovered From Loss of Taste or Smell
Patients with loss of taste or smell from baseline and back to normal during the observation period.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start15 Oct 2020
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523181
- Sponsor's protocol ID
- GHCovid-2-001
- Status last verified
- Dec 2023
- First submitted
- 19 Aug 2020
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04523181
- Acronym / sponsor ID
- GHCovid-2-001
- Conditions
- Covid-19
- Keywords
- Antroquinonol, COVID 19, pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Antroquinonol with SOC | Active comparator | Drug: AntroquinonolAntroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days. |
| Placebo with SOC | Placebo comparator | Other: PlaceboPlacebo (1 capsule) administered twice daily (BID) orally, for 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntroquinonolAlso: Hocenadouble-blind for antroquinonol and Placebo with same out-look and same frequency. | Drug | Antroquinonol with SOC |
| PlaceboCapsule without active compound | Other | Placebo with SOC |
Primary outcome
Recover Ratio
Time frame: 14 day
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.
4 secondary outcomes
Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
Time frame: 28-day
Duration of Hospitalization
Time frame: 28 day
Time to Virological Clearance
Time frame: 28 day
Number of Patients Who Recovered From Loss of Taste or Smell
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antroquinonol in people with Covid-19, run by Golden Biotechnology Corporation at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Argentina, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recover Ratio (time frame: 14 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.