Coronavirus Disease 2019Phase 2NCT04911777
Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19
A Phase 2 study testing Pentarlandir™ UPPTA in people with Coronavirus Disease 2019, run by SyneuRx International (Taiwan) Corp at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Pentarlandir™ UPPTA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 12 sitesUnited States
- Study dates
- 24 Aug 2021to Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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.
Show all 14Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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:
- 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.
Trial locations and contacts
12 sites in 1 country.
Sheena Koons contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Synergy Healthcare
Bradenton, Florida, 34208
Linda Mora, 941-896-4948, lmora@synergyhealthcorp.com
Patrick Weston, MD
- Recruiting
Cullman Clinical Trials
Cullman, Alabama, 35055
Cheryl Hargrove, 256-303-3071, cheryl@cullmanclinicaltrials.com
Jana Swindle, 256-339-3137, jana@cullmanclinicaltrials.com
- Recruiting
Elite Medical Research
Dallas, Texas, 75230
Hanney Musa, 682-367-5187, hmusa@medct.net
Kaothar Hashim, 4694900832, khashim@medct.net
- Recruiting
Cactus Clinical Research, Inc.
Gilbert, Arizona, 85233
Regina Almaraz, 602-370-4691, ralmaraz@cactusclinicalresearch.com
Anthony A Aghenta, MD
- Recruiting
Diversified Medical Practices
Houston, Texas, 77057
Denise Rodriguez, 832-229-2622, denise@biopharmainfo.net
Patricia D Salvato, MD
- Recruiting
Accurate Clinical Research
Houston, Texas, 77065
Ana Batista, 713-377-6433, abatista@accurateclinicalresearch.com
Adianez Diaz, 7133776433, adiaz@accurateclinicalmanagement.com
- Recruiting
1960 Family Practice
Houston, Texas, 77090
Alice Mouton, 281-501-5658, alice@biopharmainfo.net
Gambo Dangwaran, 2815015658, gambo@biopharmainfo.net
- Recruiting
Ayinde Clinical Research
Irving, Texas, 75038
Udeme Ebong, 469-248-6362, uebong@medct.net
Adila Siddiqi, Doctor
- Recruiting
Columbus Clinical Services
Miami, Florida, 33125
Sara Llerena, 305-631-6991, sara.llerena@columbusclinical.net
Bertha Cano, 305-631-6991, b.cano@columbusclinical.net
- Recruiting
C'A Research, LLC
Miami, Florida, 33174
Mario Llobet, 786-542-6933, caresearch.llobet@gmail.com
Giralt Yanez, MD
- Recruiting
CTMD Research
Palm Springs, Florida, 33406
Doris Rodriguez, 561-408-0613, DRODRIGUEZ@CTMDRESEARCH.COM
Martha Alcantara, 5614696704, MALCANTARA@CTMDRESEARCH.COM
- Recruiting
Eminat Research Group
Plantation, Florida, 33317
Daniel Perez, MD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof of Principle Study of Pentarlandir™ UPPTA for the Treatment of Patients With Early COVID-19
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.
Read the 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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Pentarlandir™ UPPTA, Placebo
- Keywords
- COVID-19, Pentarlandir™ UPPTA, UPPTA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentarlandir™ UPPTADrug
Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)
PlaceboDrug
The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)
| Study group | Role | What they receive |
|---|---|---|
| Pentarlandir™ UPPTA - High Dose | Experimental | High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially) Receives: Drug: Pentarlandir™ UPPTA |
| Pentarlandir™ UPPTA - Low Dose | Experimental | Low dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially) Receives: Drug: Pentarlandir™ UPPTA; Drug: Placebo |
| Placebo | Placebo comparator | Pacebo, q8h (over 3 hours postprandially) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in viral genome up to Day 14
Measured: Baseline and Day14
Secondary outcomes (10)
Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14.
Measured: Day 3, 7, 10, and 14
Change from baseline in daily COVID-19-related symptom severity score through 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))
Measured: Baseline to Day 28
Number of days with substantial COVID-19-associated symptoms from start of study treatment (Day 1) based on self-assessment using daily symptom diary.
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
Measured: 28 days
Number of days without COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
Symptom-free days are defined as number of days when all the symptoms score as absent (or none) in ePRO through Day 28.
Measured: 28 days
Number of days with limited COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
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.
Measured: 28 days
Number of days with progression (or worsening) of COVID-19-associated symptoms in ePRO through Day 28 compared to baseline.
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.
Measured: Baseline to 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
Measured: 28 days
Patient-reported global impression in ePRO
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)
Measured: 28 days
Change from baseline in the patient's health status on a 7-category ordinal scale at up 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.
Measured: Baseline to Day 14
Change from baseline in pulse oxygen saturation up to Day 14
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start24 Aug 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Sequential
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SyneuRx International (Taiwan) Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911777
- Sponsor's protocol ID
- SNR08-Covid19
- Status last verified
- Dec 2021
- First submitted
- 1 Jun 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Proof of Principle Study of Pentarlandir™ UPPTA for the Treatment of Patients With Early COVID-19
- ClinicalTrials.gov ID
- NCT04911777
- Acronym / sponsor ID
- SNR08-Covid19
- Conditions
- Coronavirus Disease 2019
- Keywords
- COVID-19, Pentarlandir™ UPPTA, UPPTA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- SyneuRx International (Taiwan) CorpIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pentarlandir™ UPPTA - High Dose | Experimental | Drug: Pentarlandir™ UPPTAHigh dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially) |
| Pentarlandir™ UPPTA - Low Dose | Experimental | Drug: Pentarlandir™ UPPTA, Drug: PlaceboLow dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially) |
| Placebo | Placebo comparator | Drug: PlaceboPacebo, q8h (over 3 hours postprandially) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
- 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]
Key exclusion criteria (27 listed)
- 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.
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 |
|---|---|---|
| Pentarlandir™ UPPTAPentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA) | Drug | Pentarlandir™ UPPTA - High Dose, Pentarlandir™ UPPTA - Low Dose |
| PlaceboThe placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA) | Drug | Pentarlandir™ UPPTA - Low Dose, Placebo |
Primary outcome
Change from baseline in viral genome up to Day 14
Time frame: Baseline and Day14
10 secondary outcomes
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
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
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
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
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
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
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
Change from baseline in pulse oxygen saturation up to Day 14
Time frame: Baseline to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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.
Sheena Koons contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentarlandir™ UPPTA in people with Coronavirus Disease 2019, run by SyneuRx International (Taiwan) Corp at 12 sites in United States.
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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emil Tsai, MD, PhD (+1-818-696-8800, emil.tsai@syneurx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in viral genome up to Day 14 (time frame: Baseline and Day14). 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 17 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.