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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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 : December 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Coronavirus Disease 2019 | Drug: Pentarlandir™ UPPTA Drug: Placebo | Phase 2 |

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 |
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Experimental: Pentarlandir™ UPPTA - High Dose
High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)
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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) |
- Change from baseline in viral genome up to Day 14 [ Time Frame: Baseline and Day14 ]
- 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:
- moderate at baseline but score as severe on any day through Day28.
- mild at baseline but score as moderate or severe on any day through Day 28.
- 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 ]

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 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Early COVID-19 diagnosis with mild severity defined as meeting all of the below:
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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]
- No signs of a more serious lower airway disease per clinical exam, chest X-ray or chest CT.
- Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air.
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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]):
- Negative urine pregnancy test at screening.
- 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.
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High-risk individuals are those who meet at least one of the following criteria:
- Aged ≥ 65 years
- Body mass index (BMI) > 30
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
- 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.

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
Contact: Emil Tsai, MD, PhD | +1-818-696-8800 | emil.tsai@syneurx.com | |
Contact: Sheena Koons | sheena.koons@prevailinfoworks.com |
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 |
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Contact: Regina Almaraz 602-370-4691 ralmaraz@cactusclinicalresearch.com | |
Principal Investigator: Anthony A Aghenta, MD | |
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Contact: Linda Mora 941-896-4948 lmora@synergyhealthcorp.com | |
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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 |
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Contact: Mario Llobet 786-542-6933 caresearch.llobet@gmail.com | |
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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 |
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Elite Medical Research | Recruiting |
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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 |
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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 | |
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Contact: Alice Mouton 281-501-5658 alice@biopharmainfo.net | |
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Principal Investigator: Victor I Escobar, MD | |
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Irving, Texas, United States, 75038 | |
Contact: Udeme Ebong 469-248-6362 uebong@medct.net | |
Principal Investigator: Adila Siddiqi, Doctor |
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: | December 17, 2021 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pentarlandir™ UPPTA UPPTA |
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 |