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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

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ClinicalTrials.gov Identifier: NCT04911777

Recruitment Status : Recruiting

First Posted : June 3, 2021

Last Update Posted : November 19, 2021

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Sponsor:

Information provided by (Responsible Party):

SyneuRx International (Taiwan) Corp

Study Description

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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Detailed Description:

This is a clinical trial to evaluate the safety, PK, viral shedding and efficacy of PentarlandirTM UPPTA as a treatment for 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 48 hours, will be enrolled in the proof of principle study.

Upon signing informed consent and evaluating medical history, concomitant medications, oxygen saturation (SaO2) at room air and vital signs, a focused physical examination of the heart and lungs will be performed. Subjects will be randomized into High-Dose, Low-Dose, and Placebo group in a 1:1:1 ratio at the final sample, but the enrollment will be staggered. In the first phase, 45 study subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA low dose or placebo. After all the forty-five (45) subjects have completed the Day 21 assessment or early terminated (14-day dosing and 7 days of followed-up), DSMB will review the safety from the cohort and provide concurrence with proceeding with the higher dose cohort. If DSMB deems that the study is safe to proceed, another 45 subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA high dose or placebo in the second phase. Both staggered cohorts will have the same stopping rules.

During both phases of study, specimens for quantification of the viral genome, inflammatory markers, and safety laboratory tests will be collected. The IP will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the clinic. Study subjects will be instructed (and provided) to use a device for ePRO for how to complete the patient-reported diary.

The subjects will take the IP orally. Subjects in the low-dose group will take from each bottle of the active drug and placebo every 8 hours (q8h); for the high-dose group, from each of the two bottles of active drug; and for the placebo group, from each of the two bottles of placebo for 14 days. The first treatment dose should be taken within 4 days of COVID-19 diagnosis. Physical examination, specimen collection, laboratory evaluations and urine pregnancy test, vital signs, pulse oxygen saturation and clinical symptom and status determination will be conducted.

Subjects who meet the eligibility criteria will be randomized. All subjects who fail to meet eligibility criteria are considered screen failures and are exited from the study without further evaluation.

Screening and Randomization (V1, Day 1):

After determining the eligibility, the study subjects will be randomized 2:1 to Pentarlandir™ UPPTA (either low or high dose) or placebo. The IP for treatment period will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the study site. Study subjects will be instructed (and provided) how to complete the electronic patient reported outcome (ePRO) on a device.

Treatment Period (V2 - V14 (EOT), Day 2 - Day 14):

The subjects will continue to document the daily diary of ePRO. Total 13 visits are included in this period. Except 4 in-persons visits (V3, V7, V10, and V14), no in-person visit is expected during the study. Subjects will return to the clinical study sites to collect specimens for quantification of viral genome, inflammatory markers, pharmacokinetic and safety laboratory tests as well as record the SaO2, oral temperature, heart and respiratory rate, blood pressure, symptoms and concomitant medications, to document clinical status and adverse events (AEs), and IP accountability will be monitored. In addition, clinical symptom assessments and 7-category ordinal scale will be evaluated as well along with safety laboratory evaluations to determine whether the subject will continue to take the IP or stop the clinical trial. The subject will return the study treatment bottles at EOT visit.

Except for the in-person visits, subjects will be phone-called once every day between 8:00 AM and 7:00 PM on the visits to record concomitant medications and to document clinical status and 7-category ordinal scale as well as adverse events (AEs) to determine whether the subject will be taken of the IP and/or stop the clinical trial.

Weekly Follow-Up Period (V15 - V20, Day 15 - Day 56):

Between Day 15 to 28, subjects will perform the ePRO diary daily. In addition to ePRO, study subjects will be called every 7±2 days after EOT visit to document final outcome and AEs up to Day 56. AE/SAEs, hospital and ICU lengths of stays, and mortality in hospitalized subjects will be documented.

Study Design

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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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

Change from baseline in viral genome up to Day 14 [ Time Frame: Baseline and Day14 ]

Secondary Outcome Measures :

Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14. [ Time Frame: Day 3, 7, 10, and 14 ]
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))
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
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.
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.
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.
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 ]
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)
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.
Change from baseline in pulse oxygen saturation up to Day 14 [ Time Frame: Baseline to Day 14 ]

Eligibility Criteria

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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:

Men and women 18 years of age or older.
Able and willing to provide informed consent.
Able and willing to sufficiently operate smart phones and study-provided monitoring devices per the Investigator.
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.
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.
Ability and willingness to comply with all aspects of the study through the entire study period.

Exclusion Criteria:

Patient is either asymptomatic or with baseline severity of moderate, sever, or critical COVID-19.
Pregnant or lactating women.
Patients with shortness of breath at rest.
Findings on physical examination or available imaging studies suggesting rapid disease progression of COVID-19.
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.
Need for immediate hospitalization, oxygen supplementation or mechanical ventilation.
Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD) and asthma, or other respiratory disease that could exacerbate independent of COVID-19.
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.
Patients who are participating in other clinical trials.
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.
Barium enemas within the last 30 days.
Taking OTC or prescribed medicine which has compound as active ingredient.
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.
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.
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.

Contacts and Locations

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

More Information

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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

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