Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19
A Randomized, Double-Blind, Placebo-Controlled, Proof of Principle Study of Pentarlandir™ UPPTA for the Treatment of Patients With Early COVID-19
1 other identifier
interventional
90
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedStudy Start
First participant enrolled
August 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedDecember 17, 2021
December 1, 2021
3 months
June 1, 2021
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in viral genome up to Day 14
Baseline and Day14
Secondary Outcomes (10)
Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14.
Day 3, 7, 10, and 14
Change from baseline in daily COVID-19-related symptom severity score through Day 28
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.
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.
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.
28 days
- +5 more secondary outcomes
Study Arms (3)
Pentarlandir™ UPPTA - High Dose
EXPERIMENTALHigh dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)
Pentarlandir™ UPPTA - Low Dose
EXPERIMENTALLow dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially)
Placebo
PLACEBO COMPARATORPacebo, q8h (over 3 hours postprandially)
Interventions
Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)
The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Cactus Clinical Research, Inc.
Gilbert, Arizona, 85233, United States
Synergy Healthcare
Bradenton, Florida, 34208, United States
Columbus Clinical Services
Miami, Florida, 33125, United States
C'A Research, LLC
Miami, Florida, 33174, United States
CTMD Research
Palm Springs, Florida, 33406, United States
Eminat Research Group
Plantation, Florida, 33317, United States
Elite Medical Research
Dallas, Texas, 75230, United States
Diversified Medical Practices
Houston, Texas, 77057, United States
Accurate Clinical Research
Houston, Texas, 77065, United States
1960 Family Practice
Houston, Texas, 77090, United States
Ayinde Clinical Research
Irving, Texas, 75038, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 3, 2021
Study Start
August 24, 2021
Primary Completion
December 1, 2021
Study Completion
March 1, 2022
Last Updated
December 17, 2021
Record last verified: 2021-12