COVID-19Phase 2NCT05442983
A Study to Evaluate the Efficacy of PanCytoVir™ for the Treatment of Non-Hospitalized Patients With COVID-19 Infection
A Phase 2 study testing PanCytoVir™ (probenecid) in people with COVID-19, run by TrippBio, Inc. at 1 site in India.
Trial summary
This is a randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVir™ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- PanCytoVir™ (probenecid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jul 2022to 8 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-hospitalized Patients with RT-PCR confirmed COVID-19 in ≤ 48 hours prior to randomization.
- Patients with WHO Ordinal Scale score 1 and 2.
- Patient has presented within 5 days or less of randomization with at least one early onset COVID-19 symptom (i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting or diarrhea).
- Men and non-pregnant women, 18 - 65 years of age.
- Patient has estimated glomerular filtration rate (eGFR) ≥30 mL/min using the Cockcroft-Gault formula.
- Willing to participate in this study, signed Informed Consent and willing to participate in regular follow-up during the study.
- Able to understand and cooperate with study procedures. -
Who cannot join
- Subjects hospitalized (a) Patients with severe or critical forms of COVID-19 illness or those who are on ventilator support, ECMO, or shock requiring vasopressor support or those with cytokine storm; even not in hospital (b) Patients hospitalized for treatment of severe illnesses (c) "Long COVID-19" syndrome (defined as a diverse set of symptoms that persist after a minimum of 4 weeks from the onset of a diagnosed COVID-19 infection. Common symptoms include respiratory system disorders, nervous system and neurocognitive disorders, mental health disorders, metabolic disorders, cardiovascular disorders, gastrointestinal disorders, malaise, fatigue, musculoskeletal pain, and anemia).
- Patients with known blood dyscrasia and uric acid kidney stones.
- Females who are pregnant, breast feeding, or planning a pregnancy.
- Females of childbearing potential who do not agree to utilize an adequate effective form of contraception.
- Males with partners of child-bearing potential unwilling to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence effective from the first administration of any of the IPs throughout the trial.
- Men with partners of child-bearing potential unwilling to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel, or sexual abstinence. Men with pregnant or lactating partners unwilling to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the fetus or neonate.
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- Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the patients. Periodic abstinence (e.g., calendar, ovulation, sympathothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- History of alcohol, chemical, or drug abuse or dependence as per DSM IV criteria within past 6 months.
- Current active malignancy or history of malignancy within the past five years.
- Known hypersensitivity history to Investigational Products or any of its component.
- Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
- Patients with the following conditions:
- Immunosuppression
- HIV
- Current neoplasms
- Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma.
- Any other clinically significant abnormal medical condition, which in the Investigator's judgment, would put the patient at increased risk of illness or injury would interfere with study participation or would interfere with the evaluation or quality of the data.
- Investigator's judgment that participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.
- Is taking or is anticipated to require any prohibited medications or therapies.
- Participation in another trial within previous 3 months and is unwilling to abstain from participating in another interventional clinical study through Day 28 with an investigational compound or device, including those for COVID-19 therapeutics.
- Any patient that is already taking Investigational Medicinal Products. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-center, Single-blind, Placebo-controlled Study to Evaluate the Efficacy of PanCytoVir™ 500 mg Twice Daily and 1000 mg Twice Daily for the Treatment of Non-hospitalized Patients With COVID-19 Infection
This is a randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVir™ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection.
- Conditions
- COVID-19
- Being tested
- PanCytoVir™ (probenecid), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanCytoVir™ (probenecid)Drug
Active drug
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| PanCytoVir™ 500 mg twice daily | Experimental | Not described Receives: Drug: PanCytoVir™ (probenecid) |
| PanCytoVir™ 1000 mg twice daily | Experimental | Not described Receives: Drug: PanCytoVir™ (probenecid) |
| Placebo twice daily | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Viral Clearance
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start12 Jul 2022
- Primary completion7 Sep 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrippBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David E Martin, PharmD, Study director, TrippBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442983
- Sponsor's protocol ID
- COVID-19/01/05/2022
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martin DE, Pandey N, Chavda P, Singh G, Sutariya R, Sancilio F, Tripp RA. Oral Probenecid for Nonhospitalized Adults with Symptomatic Mild-to-Moderate COVID-19. Viruses. 2023 Jul 6;15(7):1508. doi: 10.3390/v15071508.
PubMed 37515194
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Single-blind, Placebo-controlled Study to Evaluate the Efficacy of PanCytoVir™ 500 mg Twice Daily and 1000 mg Twice Daily for the Treatment of Non-hospitalized Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05442983
- Acronym / sponsor ID
- COVID-19/01/05/2022
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TrippBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 5 Jul 2022 (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 randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVir™ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PanCytoVir™ 500 mg twice daily | Experimental | Drug: PanCytoVir™ (probenecid) |
| PanCytoVir™ 1000 mg twice daily | Experimental | Drug: PanCytoVir™ (probenecid) |
| Placebo twice daily | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-hospitalized Patients with RT-PCR confirmed COVID-19 in ≤ 48 hours prior to randomization.
- Patients with WHO Ordinal Scale score 1 and 2.
- Patient has presented within 5 days or less of randomization with at least one early onset COVID-19 symptom (i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting or diarrhea).
- Men and non-pregnant women, 18 - 65 years of age.
- Patient has estimated glomerular filtration rate (eGFR) ≥30 mL/min using the Cockcroft-Gault formula.
Key exclusion criteria (21 listed)
- Subjects hospitalized (a) Patients with severe or critical forms of COVID-19 illness or those who are on ventilator support, ECMO, or shock requiring vasopressor support or those with cytokine storm; even not in hospital (b) Patients hospitalized for treatment of severe illnesses (c) "Long COVID-19" syndrome (defined as a diverse set of symptoms that persist after a minimum of 4 weeks from the onset of a diagnosed COVID-19 infection. Common symptoms include respiratory system disorders, nervous system and neurocognitive disorders, mental health disorders, metabolic disorders, cardiovascular disorders, gastrointestinal disorders, malaise, fatigue, musculoskeletal pain, and anemia).
- Patients with known blood dyscrasia and uric acid kidney stones.
- Females who are pregnant, breast feeding, or planning a pregnancy.
- Females of childbearing potential who do not agree to utilize an adequate effective form of contraception.
- Males with partners of child-bearing potential unwilling to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence effective from the first administration of any of the IPs throughout the trial.
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 |
|---|---|---|
| PanCytoVir™ (probenecid)Active drug | Drug | PanCytoVir™ 1000 mg twice daily, PanCytoVir™ 500 mg twice daily |
| PlaceboMatching placebo | Drug | Placebo twice daily |
Primary outcome
Time to Viral Clearance
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 37515194Martin DE, Pandey N, Chavda P, Singh G, Sutariya R, Sancilio F, Tripp RA. Oral Probenecid for Nonhospitalized Adults with Symptomatic Mild-to-Moderate COVID-19. Viruses. 2023 Jul 6;15(7):1508. doi: 10.3390/v15071508.
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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.
David E Martin, PharmD study director
TrippBio, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PanCytoVir™ (probenecid) in people with COVID-19, run by TrippBio, Inc. at 1 site in India.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Viral Clearance (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442983, which also lists 1 linked publication.
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 25 Aug 2023.