A Study to Evaluate the Efficacy of PanCytoVir™ for the Treatment of Non-Hospitalized Patients With COVID-19 Infection

NCT05442983 | Completed Phase 2

• 1 other identifier: COVID-19/01/05/2022
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to Viral Clearance

  5 days

Study Arms (3)

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

Interventions

PanCytoVir™ (probenecid) DRUG

Active drug

PanCytoVir™ 1000 mg twice daily; PanCytoVir™ 500 mg twice daily

Placebo DRUG

Matching placebo

Placebo twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• TrippBio, Inc.: lead

Study Sites (1)

PCMCs PGI Yashwantrao Chavan Memorial Hospital

Pune, India

Location

Related Publications (1)

• 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.

  PMID: 37515194 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Probenecid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• David E Martin, PharmD

  TrippBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 5, 2022
• Study Start: July 12, 2022
• Primary Completion: September 7, 2022
• Study Completion: October 8, 2022
• Last Updated: August 25, 2023

Record last verified: 2022-10

Locations

IN (1)