We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05442983
Recruitment Status : Not yet recruiting
First Posted : July 5, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
TrippBio, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: PanCytoVir™ (probenecid) Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 12, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Probenecid

Arm Intervention/treatment
Experimental: PanCytoVir™ 500 mg twice daily Drug: PanCytoVir™ (probenecid)
Active drug

Experimental: PanCytoVir™ 1000 mg twice daily Drug: PanCytoVir™ (probenecid)
Active drug

Placebo Comparator: Placebo twice daily Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Time to Viral Clearance [ Time Frame: 5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  9. Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
  10. Patients with the following conditions:

    1. Immunosuppression
    2. HIV
    3. Current neoplasms
  11. Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma.
  12. 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.
  13. 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.
  14. Is taking or is anticipated to require any prohibited medications or therapies.
  15. 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.
  16. Any patient that is already taking Investigational Medicinal Products. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05442983


Contacts
Layout table for location contacts
Contact: David E Martin, PharmD 301-538-1878 davidmartin@trippbio.com

Sponsors and Collaborators
TrippBio, Inc.
Investigators
Layout table for investigator information
Study Director: David E Martin, PharmD TrippBio, Inc.
Layout table for additonal information
Responsible Party: TrippBio, Inc.
ClinicalTrials.gov Identifier: NCT05442983    
Other Study ID Numbers: COVID-19/01/05/2022
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Probenecid
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents