COVID-19
Oral Antiviral Trial
This is a Phase II clinical trial testing the safety and efficacy of Pentarlandir for COVID patients with mild symptoms.
Enrollment Closed
Summary
COVID-19
Pentarlandir, oral tablets 6x every 8 hours
18 to 64 years old
All genders
Confirmed COVID-PCR within prior 4 days
2 weeks plus 6 weeks follow-up
- Condition
- Treatment
- Age
- Gender
- Other Criteria
- Study Duration
- Trial Sites
- Additional Information
- COVID-19
- Pentarlandir, oral tablets 6x every 8 hours
- 18 to 64 years old
- All genders
- Confirmed COVID-PCR within prior 4 days
- 2 weeks plus 6 weeks follow-up
- US
- Clinicaltrial.gov
- 中文相關臨床資訊
About The Study
The SNB01 COVID-19 Antiviral Study is one of SyneuRx’s efforts to bring new treatment options to COVID-19 patients.
This is a phase II clinical study to examine the safety and effectiveness of Pentarlandir® UPPTA to improve the symptoms of early and mildly infected patients who have been diagnosed with COVID-19 within the prior 4 days.
The duration of your participation in this study will be approximately eight (8) weeks. During the study, participants will visit a study center five (5) times, including one (1) screening and four (4) active treatment in-person visits. There are also several phone visits between the in-person visits.
About Pentarlandir®
Pentarlandir® ultrapure and potent tannic acid (UPPTA) is an investigational therapy with botanic origin. As such, it has demonstrated an excellent safety profile.
In the preclinical work, Pentarlandir® UPPTA has demonstrated potential to inhibit SARS-CoV-2 in 3 ways:
(1) inhibit on the main protease of SARS-CoV-2 to suppress virus replication
(2) to block the TMPRSS2 protease of human cells to prevent virus entry into human cells, and
(3) provide anti-inflammatory effect against cytokine storm that can lead to the deterioration of the illness.
Eligibility
Major Inclusion Criteria
- Adults between 18 and 64 years of age
- Confirmed of COVID-19 by PCR test within prior 4 days
- Mild COVID-19 symptoms
Major Exclusion Criteria
- Asymptomatic or moderate, sever, or critical COVID-19 symptoms
- Use of approved, EUA, or investigational COVID-19 therapy
- Body Mass Index over 30
- People at high-risk of progressing to severe COVID-19 (such as chronic kidney disease, diabetes, immunosuppressive disease, cardiovascular disease, chronic lung diseases, ... etc
Frequently Asked Questions
You are eligible if you meet the major inclusion and exclusion criteria above. Please contact us for further study screening and referral to a study center near you.
Please contact us for study screening and referral to a study center near you.
Pentarlandir® is ultrapure and potent tannic acid which developed by SyneuRx to work against the virus ‘SARS-CoV-2’, which has caused the global COVID-19 pandemic since 2019. In the preclinical work, Pentarlandir® UPPTA has demonstrated potential to inhibit SARS-CoV-2 in 3 ways: (1) inhibiting the main protease of SARS-CoV-2 to suppress virus replication (2) inhibiting the transmembrane protease serine 2 (TMPRSS2) of human cells to block virus entry into human cells, and (3) providing anti-inflammatory effect against cytokine storm that can lead to the deterioration of the illness. These mechanisms may help to improve and recover from the COVID-19 illness of the infected patients.
There is no cost to participate in the study. The cost of study-related health assessments and study medication will be covered. If you need a caregiver, transportation, or assistance to come to the study site, the study center can help to arrange needed supports to reduce the barrier(s) to come to the study.
The study is eight (8) weeks, including 2 weeks of treatment and 6 weeks follow-up long. Participants will visit a study center five (5) times, including one (1) screening and four (4) active treatment in-person visits. There are also several visits which will be conducted by phone call during active treatment and follow-up phases.
Participation in the study is completely voluntary. One may refuse to participate or may withdraw from the study at any time. However, it is recommended that one adhere to the study regime and visit the study center consistently throughout the study, so long as there are no safety or other concerns.