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Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04911777
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
SyneuRx International (Taiwan) Corp

Brief Summary:
This is a clinical trial to evaluate the safety, PK, viral shedding and clinical effects of Pentarlandir™ UPPTA in patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 4 days will be enrolled.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Drug: Pentarlandir™ UPPTA Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: In the first phase, 45 subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA low dose or placebo. After interim analysis and evaluate by DSMB, 45 subjects will be randomized to 2:1 ratio to Pentarlandir™ UPPTA high dose or placebo in second phase. The final sample will be high-dose, low-dose, and placebo group at 1:1:1 ratio.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Proof of Principle Study of Pentarlandir™ UPPTA for the Treatment of Patients With Early COVID-19
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Pentarlandir™ UPPTA - High Dose
High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)
Drug: Pentarlandir™ UPPTA
Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)

Experimental: Pentarlandir™ UPPTA - Low Dose
Low dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially)
Drug: Pentarlandir™ UPPTA
Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)

Drug: Placebo
The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)

Placebo Comparator: Placebo
Pacebo, q8h (over 3 hours postprandially)
Drug: Placebo
The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)




Primary Outcome Measures :
  1. Change from baseline in viral genome up to Day 14 [ Time Frame: Baseline and Day14 ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14. [ Time Frame: Day 3, 7, 10, and 14 ]
  2. Change from baseline in daily COVID-19-related symptom severity score through Day 28 [ Time Frame: Baseline to Day 28 ]
    A set of common COVID-19-related symptoms (see patient diary template for electronic Patient Report Outcome (ePRO)) will be evaluated daily by the patient regardless of which symptoms he/she had at baseline, as new symptoms may appear following the baseline assessment. (A Likert symptom scale will be developed using the (The 24 items reported in the ePRO, with potentially each item being normalized to 0 to 3 and the total score ranging from ranged 0 to 72))

  3. Number of days with substantial COVID-19-associated symptoms from start of study treatment (Day 1) based on self-assessment using daily symptom diary. [ Time Frame: 28 days ]
    Substantial COVID-19-associated symptom days are defined as number of days when any symptoms score as moderate or sever in ePRO through Day 28

  4. Number of days without COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary. [ Time Frame: 28 days ]
    Symptom-free days are defined as number of days when all the symptoms score as absent (or none) in ePRO through Day 28.

  5. Number of days with limited COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary. [ Time Frame: 28 days ]
    Days with limited COVID-19-associated symptoms are defined as number of days when up to two symptoms score as mild or absent while the rest score as absent (or none) in ePRO through Day 28.

  6. Number of days with progression (or worsening) of COVID-19-associated symptoms in ePRO through Day 28 compared to baseline. [ Time Frame: Baseline to Day 28 ]

    Progression or symptom worsening is defined as number of days when any symptoms scored as:

    1. moderate at baseline but score as severe on any day through Day28.
    2. mild at baseline but score as moderate or severe on any day through Day 28.
    3. absent at baseline but score as mild, moderate or worse on any day through Day 28.

  7. Time to resolution, where resolution is defined as when a subject has scored absent (or none) on all COVID-19-associated symptoms for two consecutive days [ Time Frame: 28 days ]
  8. Patient-reported global impression in ePRO [ Time Frame: 28 days ]
    Patient-reported global impression in ePRO includes the following "In general, would you say that your health is excellent, very good, fair, or poor?" (The scores will be ranged between 1-5; excellent to poor)

  9. Change from baseline in the patient's health status on a 7-category ordinal scale at up to Day 14 [ Time Frame: Baseline to Day 14 ]
    A 7-category ordinal scale of patient health status ranges from 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

  10. Change from baseline in pulse oxygen saturation up to Day 14 [ Time Frame: Baseline to Day 14 ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women 18 years of age or older.
  2. Able and willing to provide informed consent.
  3. Able and willing to sufficiently operate smart phones and study-provided monitoring devices per the Investigator.
  4. Early COVID-19 diagnosis with mild severity defined as meeting all of the below:

    1. Confirmation of COVID-19 by a PCR-based diagnostic within 4 days of randomization.

      • COVID-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score.
      • Clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator.

      Note: The total score per patient ranges from 0 to 27 points. Each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe]

    2. No signs of a more serious lower airway disease per clinical exam, chest X-ray or chest CT.
    3. Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air.
  5. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]):

    1. Negative urine pregnancy test at screening.
    2. Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication.
  6. Ability and willingness to comply with all aspects of the study through the entire study period.

Exclusion Criteria:

  1. Patient is either asymptomatic or with baseline severity of moderate, sever, or critical COVID-19.
  2. Pregnant or lactating women.
  3. Patients with shortness of breath at rest.
  4. Findings on physical examination or available imaging studies suggesting rapid disease progression of COVID-19.
  5. Signs or symptoms indicative of pneumonia or any other lower respiratory tract disorders, or clinically significant findings in available lung imaging studies suggestive of such disorders.
  6. Need for immediate hospitalization, oxygen supplementation or mechanical ventilation.
  7. Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD) and asthma, or other respiratory disease that could exacerbate independent of COVID-19.
  8. Use of remdesivir, chloroquine, hydroxychloroquine, convalescent plasma, other monoclonal antibody therapies, include REGEN-COV (casirivimab and imdevimab), bamlanivimab (plus etesevimab), dexamethasone, ivermectin, baricitinib, and other Janus kinase inhibitors, Bruton's tyrosine kinase inhibitors, tocilizumab (and other interleukin-6 inhibitors) and any other therapy with EUA or approval and other investigational agents for COVID-19.
  9. Patients who are participating in other clinical trials.
  10. History of conditions associated with immunocompromise, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, other chemotherapy, radiation, immune-modulating biologics, within 30 days of screening.
  11. Barium enemas within the last 30 days.
  12. Taking OTC or prescribed medicine which has compound as active ingredient.
  13. Any unstable or uncontrolled medical illnesses such as neurological disorders, cardiovascular disorders, diabetes, hepatic or renal disorders that per the Investigator would intervene with the study conduct or study results interpretation.
  14. Any other medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a patient's ability to give informed consent or respond to the study procedures or questions during the personal visits or the video calls.
  15. High-risk individuals are those who meet at least one of the following criteria:

    1. Aged ≥ 65 years
    2. Body mass index (BMI) > 30
    3. Pregnancy
    4. Chronic kidney disease
    5. Diabetes
    6. Immunosuppressive disease or immunosuppressive treatment
    7. Cardiovascular disease (including congenital heart disease) or hypertension
    8. Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
    9. Sickle cell disease
    10. Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
    11. Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
    12. Exclusion is not limited to the medical conditions or factors listed above. The investigators have to consider the benefit-risk for an individual patient to determine other medical conditions or factors (for example, overweight, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and be excluded.

Information from the National Library of Medicine

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): NCT04911777


Contacts
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Contact: Emil Tsai, MD, PhD +1-818-696-8800 emil.tsai@syneurx.com
Contact: Sheena Koons sheena.koons@prevailinfoworks.com

Locations
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United States, Alabama
Cullman Clinical Trials Recruiting
Cullman, Alabama, United States, 35055
Contact: Cheryl Hargrove    256-303-3071    cheryl@cullmanclinicaltrials.com   
Contact: Jana Swindle    256-339-3137    jana@cullmanclinicaltrials.com   
Principal Investigator: Justin Wilson, CRNP         
United States, Arizona
Cactus Clinical Research, Inc. Recruiting
Gilbert, Arizona, United States, 85233
Contact: Regina Almaraz    602-370-4691    ralmaraz@cactusclinicalresearch.com   
Principal Investigator: Anthony A Aghenta, MD         
United States, Florida
Synergy Healthcare Recruiting
Bradenton, Florida, United States, 34208
Contact: Linda Mora    941-896-4948    lmora@synergyhealthcorp.com   
Principal Investigator: Patrick Weston, MD         
Columbus Clinical Services Recruiting
Miami, Florida, United States, 33125
Contact: Sara Llerena    305-631-6991    sara.llerena@columbusclinical.net   
Contact: Bertha Cano    305-631-6991    b.cano@columbusclinical.net   
Principal Investigator: Sara Llerena, MD         
C'A Research, LLC Recruiting
Miami, Florida, United States, 33174
Contact: Mario Llobet    786-542-6933    caresearch.llobet@gmail.com   
Principal Investigator: Giralt Yanez, MD         
CTMD Research Recruiting
Palm Springs, Florida, United States, 33406
Contact: Doris Rodriguez    561-408-0613    DRODRIGUEZ@CTMDRESEARCH.COM   
Contact: Martha Alcantara    5614696704    MALCANTARA@CTMDRESEARCH.COM   
Principal Investigator: Luis Castillo, MD         
Eminat Research Group Recruiting
Plantation, Florida, United States, 33317
Principal Investigator: Daniel Perez, MD         
United States, Texas
Elite Medical Research Recruiting
Dallas, Texas, United States, 75230
Contact: Hanney Musa    682-367-5187    hmusa@medct.net   
Contact: Kaothar Hashim    4694900832    khashim@medct.net   
Principal Investigator: Gustavo Day, MD         
Diversified Medical Practices Recruiting
Houston, Texas, United States, 77057
Contact: Denise Rodriguez    832-229-2622    denise@biopharmainfo.net   
Principal Investigator: Patricia D Salvato, MD         
Accurate Clinical Research Recruiting
Houston, Texas, United States, 77065
Contact: Ana Batista    713-377-6433    abatista@accurateclinicalresearch.com   
Contact: Adianez Diaz    7133776433    adiaz@accurateclinicalmanagement.com   
Principal Investigator: Aramis Cosme, MD         
1960 Family Practice Recruiting
Houston, Texas, United States, 77090
Contact: Alice Mouton    281-501-5658    alice@biopharmainfo.net   
Contact: Gambo Dangwaran    2815015658    gambo@biopharmainfo.net   
Principal Investigator: Victor I Escobar, MD         
Sponsors and Collaborators
SyneuRx International (Taiwan) Corp
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Responsible Party: SyneuRx International (Taiwan) Corp
ClinicalTrials.gov Identifier: NCT04911777    
Other Study ID Numbers: SNR08-Covid19
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SyneuRx International (Taiwan) Corp:
COVID-19
Pentarlandir™ UPPTA
UPPTA
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases