Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVirâ„¢ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanCytoVirâ„¢ 500 mg twice daily | Experimental |
| |
| PanCytoVirâ„¢ 1000 mg twice daily | Experimental |
| |
| Placebo twice daily | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PanCytoVirâ„¢ (probenecid) | Drug | Active drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Viral Clearance | 5 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
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:
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. -
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David E Martin, PharmD | TrippBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PCMCs PGI Yashwantrao Chavan Memorial Hospital | Pune | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37515194 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Sulfur Compounds |