Clinical trial NCT04523181: Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid-19
Keywords: Antroquinonol
COVID 19
pneumonia
Lead sponsor: Golden Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recover Ratio
timeFrame: 14 day
Secondary outcomes:
measure: Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
timeFrame: 28-day
measure: Duration of Hospitalization
timeFrame: 28 day
measure: Time to Virological Clearance
timeFrame: 28 day
measure: Number of Patients Who Recovered From Loss of Taste or Smell
timeFrame: 28 days
Other outcomes:
Locations:
city: Michigan City
country: United States
facility: Franciscan Health Michigan City
state: Indiana
city: Wichita
country: United States
facility: Ascension.Via Christi Research
state: Kansas
city: Rockville
country: United States
facility: Adventist Healthcare Shady Grove Medical Center
state: Maryland
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Lumberton
country: United States
facility: Duke University Southeastern Health
state: North Carolina
city: Buenos Aires
country: Argentina
facility: Centro Gallego
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Clinica de los Virreyes
state: Capital Federal
city: Cordoba
country: Argentina
facility: Sanatorio Privado Mayo SA
state: Ciudad De Cordoba
city: Cordoba
country: Argentina
facility: Hospital Rawson
state: Cuidad De Cordoba
city: Viedma
country: Argentina
facility: Clinica Viedma SA
state: Pcia De Rio Negro
city: Lima Cercado
country: Peru
facility: Clínica Internacional S.A. - Sede Lima
state: Lima
city: Callao
country: Peru
facility: Unidad de Investigacion, Hospital Nacional IV Alberto Sabogal Sologuren-Essalud, Red Assitencial Sabogal
city: Chancay
country: Peru
facility: Hospital de Chancay
city: Iquitos
country: Peru
facility: Asociación Civil Selva Amazónica
city: Tacna
country: Peru
facility: Hospital III Daniel Alcides Carrion - EsSalud
Study officials:
References: