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

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

NCT05442983•TrippBio, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Non-hospitalized Patients with RT-PCR confirmed COVID-19 in ≤ 48 hours prior to randomization.
•2. Patients with WHO Ordinal Scale score 1 and 2.
•3. 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).
•4. Men and non-pregnant women, 18 - 65 years of age.
•5. Patient has estimated glomerular filtration rate (eGFR) ≥30 mL/min using the Cockcroft-Gault formula.
•6. Willing to participate in this study, signed Informed Consent and willing to participate in regular follow-up during the study.
•7. Able to understand and cooperate with study procedures. -

Exclusion Criteria

•1. 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).
•2. Patients with known blood dyscrasia and uric acid kidney stones.
•3. Females who are pregnant, breast feeding, or planning a pregnancy.
•4. Females of childbearing potential who do not agree to utilize an adequate effective form of contraception.
•5. 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.
•1. 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.
•2. 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.
•6. History of alcohol, chemical, or drug abuse or dependence as per DSM IV criteria within past 6 months.
•7. Current active malignancy or history of malignancy within the past five years.
•8. Known hypersensitivity history to Investigational Products or any of its component.
+11 more criteria

Locations (1)

PCMCs PGI Yashwantrao Chavan Memorial Hospital

Pune, India

Key Dates

Start Date

July 12, 2022

Primary Completion Date

September 7, 2022

Completion Date

October 8, 2022

Last Updated

August 25, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

PanCytoVir™ (probenecid)

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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